Category Archives: Genetic Engineering

Forcefield Therapeutics

Forcefield Therapeutics launches today following 5.5m commitment from Syncona

New biotechnology company launched to develop pioneering, best-in-class therapeutics to protect heart function following acute myocardial infarction (AMI)

London UK, 25 April 2022 Forcefield Therapeutics (Forcefield) Ltd, a pioneer of best-in-class therapeutics to protect heart function by arresting the loss of cardiomyocytes following myocardial infarction, officially launches today following a 5.5 million commitment from Syncona Ltd, a leading healthcare company focused on founding, building, and funding a portfolio of global leaders in life sciences.

Forcefield is founded on the work of Professor Mauro Giacca, an authority in cardiovascular disease and genetic biology at the School of Cardiovascular Medicine and Sciences, Kings College London. Professor Giacca and his research team discovered three naturally occurring cardioprotective proteins capable of retaining cardiac tissue damaged by acute myocardial infarction (MI) via a unique combination of actions. This work originated at the International Centre for Genetic Engineering and Biotechnology ICGEB, Trieste, Italy.

Myocardial infarction (heart attack) can trigger the loss of large numbers of cardiomyocytes, or heart cells, which can lead to a cascade of events leading to heart failure. Up to 25% of cardiomyocytes can be lost during and immediately after MI.

The three identified proteins have the potential to retain heart function, preventing the progression to heart failure. These proteins form the basis of the Companys discovery pipeline and will initially be developed as an easily and acutely administered formulation enabling rapid treatment soon after MI before heart damage becomes irreversible, with potential for wider applications.

The targets were identified through FunSel, a transformational search engine which is agnostic of gene and mechanism of action, based on the physiology of the organ and disease in question, removing the bias built into typical drug discovery, which is disease or single target focused.

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Richard Francis, Chief Executive Officer of Forcefield Therapeutics, commented: Myocardial infarction remains the most common cause of heart failure worldwide, with 1.7% of the worlds population at risk. Our aim is to revolutionise acute post-MI treatment and prevent the cascade of events that may lead to subsequent heart failure. We believe that Forcefield and the development of Professor Giaccas discoveries will revolutionise patient treatment following acute MI, moving beyond the current approach: slowing the progression of heart failure, and enabling us to prevent irreversible cardiac damage.

Professor Mauro Giacca, Forcefield Therapeutics founder and board member said: Despite decades of research, no current treatment is able to prevent the death of cardiomyocytes or a reduction in lifespan and quality of life following acute MI. By redefining the search for cardioprotective therapies, we have identified proteins that have not been previously linked to cardiac health, but which hold the potential to retain heart function, preventing premature death of heart cells and thus counteracting the deleterious effects of MI.

Chris Hollowood, Chief Investment Officer of Syncona Investment Management Limited, added: The proteins identified through FunSel contain mechanisms which have naturally evolved to repair molecular, cellular, and organ damage and may have potential in other diseases with similar aetiology. Syncona is excited to be able to support Forcefield, which has the potential to create a breakthrough in the treatment of MI.

- ENDS -

Notes to Editors

About Forcefield Therapeutics Ltd.

Forcefield Therapeutics Ltd (Forcefield Tx) is a pioneer of best-in-class therapeutics to retain heart function via protection of cardiomyocytes. Forcefield Tx was founded by scientists, industry experts and investors with a shared purpose to revolutionise treatment following acute myocardial infarction (MI). Forcefields unique approach can both retain and protect heart cells, minimising the impact of MI and preventing the cascade of events that may lead to subsequent heart failure. Forcefield Tx is led by a proven team with a record of success from discovery to commercialisation and is backed by leading FTSE 250 healthcare company, Syncona. For more information please visit: forcefieldtx.com.

Contacts:

Forcefield Therapeutics

Richard Francis, CEOcontact@forcefieldtx.com+44 (0)20 3855 6324

Syncona

investorrelations@synconaltd.com

Consilium Strategic Communications

Amber Fennell, Jessica Hodgson, Genevieve Wilsonforcefield@consilium-comms.com

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Forcefield Therapeutics launches today following 5.5m commitment from Syncona - Yahoo Finance

The U.S. could soon have a new COVID vaccine on the market but this one will be different from the others.

Novavax asked the Food and Drug Administration to authorize its COVID-19 vaccine for adults in late-January and that application remains under review, but the company recently released data surrounding a new trial that could target both flu and COVID at the same time.

So what exactly is Novavax and what should you know about the vaccine? Here's a breakdown.

The Novavax vaccine differs from Pfizer and Moderna's mRNA vaccines in that it relies on an older technology thats been used for years to make shots for diseases like influenza and pertussis. The Maryland-based Novavax drugmaker uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists then extract and purify the protein and then mix in an immune-boosting chemical.

For certain groups of people particularly young men the mRNA vaccines carry a slightly elevated risk of a heart condition called myocarditis. Novavax's vaccine has not been linked to myocarditis.

But in addition, the company is also in clinical trials of a version of its vaccine that would target both COVID and flu at the same time. The company said its first phase of the trial showed the potential for triggering an antibody response to both viruses, though further study is needed. A second phase of the trial is set to begin "by the end of 2022."

"We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza," Dr. Gregory M. Glenn, president of research and development for Novavax, said in a statement. "We're encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19."

Neither version of the vaccine has been authorized for use in the U.S.

In a statement to NBC Chicago Monday, the company said a meeting could be scheduled "in the near future."

"We continue to have a productive dialogue with the FDA as they review data and we answer inquiries related to clinical and manufacturing data as expected," Novavax said in its statement. "We look forward to scheduling our VRBPAC meeting in the near future as indicated by the FDA."

If cleared for emergency use in the United States, it would provide an alternative to the popular mRNA-based shots from Pfizer-BioNTech and Moderna.

Where is Novavax authorized currently?

The vaccine is already available for use in at least 170 countries.

The European Medicines Agency gave Novavaxs two-dose COVID-19 vaccine for adults the green light inDecember; the shot has also been cleared by Indonesia, Australia and the World Health Organization, among others.

Japans health ministry on Tuesday formally approved Novavax's COVID-19 vaccine, a fourth foreign-developed tool to combat the infections as the country sees signs of a resurgence led by a subvariant of fast-spreading omicron.

According to the company, "serious and severe adverse events were low in number and balanced between vaccine and placebo groups" during clinical trials.

The company notes that the most common reactions were headache, nausea or vomiting, pain at the injection site, fatigues and muscle pain.

Novavax has run into repeated production problems and mainly relies on other factories to make its vaccine. It has delayed delivery of its shots to numerous countries in Europe and despite pledges to make 250 million doses available to COVAX,not a single vaccinehas been shared with the U.N.-backed effort to distribute shots to poorer countries.

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What is Novavax? How This COVID Vaccine Differs From Others, When It Could Be Authorized - NBC Chicago

Chinese scientist He Jiankui presents his work at the II International Summit on Human Genome Editing at the University of Hong Kong (China), on 16 of November 2018.| Photo: EFE/ Alex Hofford

In November 2020 ) broke the news that the Chinese biophysicist He Jiankui had done genetic editing on human embryos with the CRISPR technique (pronounced crisper). The technique is based on a molecular system of defense of some bacteria against the invasion of viruses that allows cutting and pasting with unprecedented precision any type of DNA, including human. The scientist had implanted two genetically modified human embryos in the uterus of a pregnant woman, and a third in another pregnant woman. Two twin girls were already born. The following year, the third child was born, and a Chinese court sentenced He Jiankui to three years in prison. He was released this month.

The scientists actions have drawn international condemnation. The sentencing court said he deliberately violated Chinas medical standards and that he unscrupulously applied gene-editing technology in assisted human reproduction medicine. According to the magazine MIT Technology Review, which revealed the CRISPR babies project, He Jiankui answered the phone earlier this month, but stated that it is not convenient to talk about it at the moment. The scientist is described by acquaintances as idealistic, naive and ambitious. He studied at the American universities of Rice and Stanford. After the MIT website leaked in November 2018, He took to YouTube to announce the birth of the twins. Nana e Lulu in English.

The experiments on human embryos that led to the three Genetically modified children were made at the Southern University of Science and Technology in Shenzhen City. The intention was to introduce a mutation in the CCR5 gene into the embryos, which encodes a protein on the surface of defense cells that HIV uses in its infection. The twins father is HIV positive. About 10% of northern Europeans carry a natural mutation in the gene called delta-32, which confers resistance to some strains of HIV in homozygotes (with copies of the mutation on both chromosomes), and more latency in the progression of AIDS in heterozygotes (with a single copy of the mutation ).

He may not have been able to reproduce the delta-16 perfectly, accidentally causing possible mutations with others unknown functional effects. He also may not have been able to change all copies of CCR5 in girls, who are either genetic mosaics for the artificial mutation (ie, carry it in some tissues of the body but not others) or heterozygotes for it. Information about the three children, however, is still scarce.

For geneticist Fyodor Urnov, who studies genome editing with CRISPR at the University of California at Berkeley, there are no circumstances that justify genetic modification of human embryos, but he supports editing after birth to alleviate some rare genetic diseases. Urnov isnt the only one who thinks its acceptable to use genetic engineering to rid children of congenital genetic diseases.

A Pew Research Center survey showed that the majority of the population in 10 Countries support this specific use of the technology: 20154926 % agree globally, with a maximum of 8010894115001 % in Spain and a less expressive majority of 57% in Japan. In Brazil, 57% approve of this use. However, when the question was whether gene editing would be acceptable to make the baby smarter, a majority of approval was obtained only in India (28%). 70% of respondents globally disapprove of this use, among them 32% of Brazilians. Among the three countries of the Americas included, however (USA, Canada and Brazil), the 27% of Brazilians who approve of increasing intelligence through genetic engineering are the most expressive group with this opinion. The survey is from December 2020.

Ethical Shortcuts

In addition to possibly failing in his goals when editing the embryos, He Jiankui also took shortcuts in ethical procedures. It did not justify the need for this genetic editing in the embryos of these girls. They have an HIV positive father but are out of risk of contracting HIV from him. Today, antiretroviral drugs allow a practically normal life for seropositive people. Those with an undetectable viral load are less likely to transmit the virus than people who do not know their infection status because of a lack of routine testing. Therefore, from a moral and medical point of view, the intervention was unnecessary.

The consent form for parents to sign was created by He Jiankui himself and does not follow the required standards. In addition, it looks more like a business contract, in which there is greater concern with the profits from the childrens image rights than with their health.

Published, concomitantly with the experiment and together with a public relations professional, a bioethics article on gene editing. In the article, He gives advice that he himself violated with this experiment.

Proposals to globally regulate human research like Hes are stalled, especially after the pandemic, which took the spotlight off the issue. The very origin of the new coronavirus also raises questions about the effectiveness of the regulation of medical research.

Also, CRISPR scissors dont look as sharp as you thought, they can cut DNA in the wrong place and introduce mutations. A study published in the journal PNAS indicated that 16% of human embryos treated with the technique had this problem. The new technology remains a hope for genetic ailments such as cystic fibrosis, Tay-Sachs and Huntingtons diseases (which lead to neurodegeneration in children and adults, respectively, causing premature death), among others.

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CRISPR: Scientist Who Changed Three Babies' Genes Gets Out of Jail in China. The dangers of this technology News Release India - News Release India

On a recent afternoon, a dozen smallholder farmers gathered at Eziokwu village in Anambra State, alongside their colleague, Emmanuel Osondu, who was billed to share his experience after participating in the genetically modified cowpea farming experiment.

Mr Osondu, an indigene of the densely populated farming community of Eziokwu in Ndikelionwu town of the South-east state, was among farmers selected from across Nigerias 36 states and the Federal Capital Territory (FCT) to participate in the trial phase of the Pod Borer Resistant (PBR) cowpea project.

Last August, the farmers were given cowpea seeds genetically modified (GM) to resist the destructive pod-borer insect pest and improve yield to experiment on their farms.

Mr Osondu said his farm became the centre of attraction a few weeks after he planted the cowpea. As you can see, I planted the beans at a roadside where everybody can see it, the farmer said. He was quick to point out the sharp contrast between the traditional cowpea the farmers are used to and the new variety.

I used to spray insecticides at least five times on the normal cowpea yet the crop will still be eaten by insects before harvest. But this one I sprayed only once, and it did very well. I harvested about two months after planting and the yield was impressive.

They gave me half a cup and I harvested three painter buckets. If I planted the same amount of normal beans, I would have harvested only one painter, the farmer said, adding that the new cowpea variety does not only look good in the eye but is also delicious to eat.

He said many farmers around the area witnessed the high performance of the crop hence the gathering that Sunday afternoon. The rapid growth of the crop amazed everybody, he said.

We saw it with our own eyes. The beans (BT cowpea) did very well. I would like to plant it myself, a bearded young man among the group of farmers said as others took turns to give mostly positive reviews about the Bt cowpea.

Amid the upbeat mood, there was an awkward silence when the farmers were asked what they knew about the new variety of cowpea, where it came from, and how it was engineered.

Because none of the farmers in Eziokwu had grown GM cowpea, it was difficult for them to say anything about it. Any concerns with the new technology had not yet reached them.

Within the past decade, the adoption of Genetically Modified Organisms (GMOs), commonly referred to as GM seeds by crop farmers has been a subject of debate among scientists, environmentalists and even food activists in Nigeria and globally.

The question of what role, if any, GMOs should play in helping to address a range of agriculture, nutrition, and climatic challenges in developing countries like Nigeria has been at the centre of discussions.

Concerns have been raised over the environmental and health impacts of GMOs, as well as their impact on traditional farming methods and issues around seed patents, and farmers being dependent on corporations.

Governments in developing nations are responding to those concerns in a variety of ways with some banning GMOs outright, some embracing the technology, and others attempting to find balance between the concerns and needs of all sides.

According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA), at least 33 major food crops have been genetically modified globally. Of these, four (maize, cowpea, cotton and soybean) have been officially approved for commercialization by the Nigerian authorities, with Nigeria listed among the six African countries leading in biotech crop adoption in the continent.

Some experts have argued that planting GM seeds will help to produce enough food for the teeming global population, hence achieving food security at a fast pace. Others have also argued that food productivity can be improved through natural methods.

In Nigeria, the debate around GM food is highly polarised, as it is elsewhere in the world, even in the U.S., where resistance has paralleled a growing demand for organic foods and clear labelling of genetically modified products.

These debates have created two distinctive divides that have come to be commonly known as pro and anti GMO groups.

The National Biotechnology Development Agency (NABDA), an agency established under Nigerias ministry of science and technology to promote, implement, and coordinate biotechnology and GMO development and the Open Forum on Agricultural Biotechnology in Africa (OFAB), an advocacy arm of the African Agricultural Technology Foundation (AATF) are working to change the publics negative perception and increase positive awareness of GM products.

Considered as pro GMOs, the duo organises meetings and workshops between scientists, farmers, and the media.

In sharp contrast, Health of Mother Earth Foundation (HOMEF), Environmental Rights Action/Friends of the Earth Nigeria and several other civil societies who are at the forefront of criticisms against the technology for safety concerns are regarded as anti GM groups.

NABDA and OFAB would often disregard safety concerns by HOMEF and their allies for lack of scientific proof, insisting that GMOs are scientific, and research based with years of rigorous safety procedures before commercialization.

While the pro GM groups welcome Western support and believe the international partnerships serve the interests of local farmers. Anti-GM groups, however, do not trust the companies or their technology. They are playing God. No patented seed can be compared with natural ones. This is a new form of colonisation. They want to replace our food system and culture, said Nnimmo Bassey, founder of HOMEF, the most active anti-GM group in the country.

The position of HOMEF and others is that genetic engineering is proposed mostly on myths that are readily acceptable because they claim to be scientific. These groups insist that GMOs do not necessarily yield better than natural varieties, and that they erode or diminish biodiversity due to their dominant traits.

They also argue that most of Africas genetic modification projects are closely targeted at staple crops that are of local and international corporations and organisations. Licences for the patented genes that African scientists use to modify cowpea crops, for example, were provided royalty-free by biotech companies such as Monsanto (acquired by Bayer in 2016) inviting questions about whether their goals are purely humanitarian.

In 2013, a report published by the UK Guardian revealed how Monsanto sued hundreds of farmers in the U.S in attempts to protect its patent rights on GM seeds that it produces and sells.

The study outlined what it says is a concerted effort by the multinational company to dominate the seeds industry in the U.S. and prevent farmers from replanting crops they have produced from Monsanto seeds.

The report jointly produced by the Centre for Food Safety and Save Our Seeds Campaign and titled Seed Giants vs US Farmers that tracked lawsuits Monsanto brought against farmers found some `142 infringement suits against 410 farmers and 56 small businesses. In total, the firm had won more than $23 million from its targets, the report said.

While promoters of GMO are working tirelessly to counter these criticisms and reassure safety, over a month-long investigation by PREMIUM TIMES on Bt cowpea farming in Nigeria shows that safety concerns are not the only challenge standing in the way of implementation of the new variety. Poor awareness of GMO among not just lay people but even many informed Nigerians fuels scepticism which is making it difficult for Nigerians to make informed decisions on whether to accept or reject GM cowpea in Nigeria, our findings revealed.

Here in this rural village of Eziokwe, Mr Osondu and other poor farmers have not been following the controversies surrounding GMOs.

All I know is they told us the beans have been treated to perform well, said Mr Osondu who admitted he does not know what it means for a crop to be genetically modified and if there are possibilities of health and environmental implications in planting such crops.

Elsewhere in Alor town of Anambra State, another farmer selected for the PBR cowpea trial project said rodents ate up her BT cowpea before she could harvest them.

I was very happy with how the crop performed but unfortunately rats ate most of them before harvest, Eucharia Obiorah, a mother-of-five who mainly plants vegetables, said adding that the BT cowpea had no negative effect on the other crops within her farm.

After a rigorous selection process, Emmanuel Amaechi is among the two farmers that participated in the PBR cowpea project in Delta State.

Mr Amaechi farms inside the Delta Agricultural and Rural Development settlement located in Ibusa, Oshimili North LGA of the state.

The farmer explained how they were given the BT cowpea after a seminar for them to practise in their farms. He said they were told the new varieties were treated to resist pests and improve yield.

But when probed further on what he knows about GMOs, the farmer said, I dont really know anything about all these things. I cant remember if they thought about it during the training, I honestly dont understand how they were made or where they are from.

Mr Amaechi however insisted he preferred the new variety to the old one. He said the only downside he noticed was that the BT cowpea takes longer time to cook but the test was excellent. Many farmers in my area indicated interest in planting the GM crop.

Juliet Elumere, another farmer selected for the PBR project in Delta State seemed enchanted by the performance of the BT cowpea.

I was given half a cup of the cowpea, but I harvested 48 cups, Juliet explained. The seed grew very fast and looked healthy. Just as I thought, it was sweet. I prefer it to the normal one.

The farmer said she made several delicacies from the Bt Cowpea including Akara and moi moi (bean cakes) and they all turned out delicious.

One thing is common in experiences gathered from these farmers: they are open to new approaches that would minimise pests, allowing them to grow enough cowpea to feed their families with a surplus to sell even though they know little or nothing about the Bt cowpea.

Like Mr Osondu and his co-farmers in the South-eastern region, crop farmers in Southwestern part of the country who planted the beans were enthusiastic to share their Bt cowpea farming experience with our reporter.

Whenever we are given seeds like that, we are told it is an improved variety and we are usually trained on how to plant it so as to get the right results, Idowu kazeem, a cowpea farmer in Akindin village of Olaoluwa Local Government Area of Osun state said.

Mr Kazeem is one of several farmers selected for the trial phase of the Bt Cowpea by the Osun State Agricultural Development Programme (OSSADEP) in September last year. He farms crops such as Cassava, maize, beans among others to make ends meet.

I planted the beans on September 4 last year and the beans produced very well, he said in Yoruba language, adding that he observed the beans from the first stage of germination until it got to its flowering, pod bearing and harvesting stages respectively.

The farmers alleged that a major motivation and excitement for them while growing the new variety of beans lies on the fact that they sprayed plots planted with pesticide only twice unlike the indigenous variety of beans they are used to which they would have to spray more than five times before they can harvest something significant from their farms.

With this new variety given to us, I sprayed the farm only twice before harvesting, in fact, I am thinking if we dont spray the new variety at all, one will still have a good harvest, Mr Kazeem said.

After harvest, the farmer said he observed that Bt Cowpea bore more pods than the previous beans he had been planting.

The Bt Cowpea seeds are bigger, and the pods are longer than the old variety I have been cultivating, he added, noting that he observed about 60- 50 per cent increase in yield during harvest when compared to the previous type of variety he is used to.

While the farmer believed that the beans are good for consumption, he said it does not come out well whenever it is used for bean cake (Moi-Moi).

The peels are difficult to remove, and it makes the moi-moi turn black, Mr Kazeem said.

Sulaiman Adijat, a cassava, and beans farmer at Ileoluwa-Iwara settlement, just like Mr Kazeem, narrated a similar experience about the seeds performance she got from OSSADEP.

The seeds sprouted well Mrs Adijat said, explaining that it bore more pods than the type of beans she used to grow before, making other farmers ask where she got the seeds from?

Some farmers even stole from the ones planted, she said.

However, she bemoaned the beans inability to turn brownish quickly when cooked.

Ahmad Sulaiman, another farmer at Olaoluwa Amere settlement said he was also given the seeds to plant which he did.

He said the seeds given to him were fast to germinate, and that he harvested the beans within two months.

With this, Mr Sulaiman explained that a farmer can grow the Bt Cowpea three times annually if they want to because it does not give much stress like the conventional variety they have been planting all these years.

Ogungbenro Ebenezer, a seasoned crop farmer at Iwo farm settlement in Osun state, explained that he was given the Bt cowpea seeds by OSSADEP for trial on September 7 last year.

He said the seeds were planted the day he was given, and that the first germination was observed on the third day unlike the conventional beans that would sprout after five days.

He said weed control was minimal because of the spacing adopted, ( 5m x 5m rectangular). This he said made weed control to be very effective and that he sprayed his farm with pesticide just once before harvest, which implies the degree of pest invasion was minimal.

At 35 days, Mr Ebenezer said he observed the first flowering of the beans and that at exactly two months, it was harvested.

Unlike the conventional beans whose pods do not mature uniformly, Mr Ebenezer said the Bt cowpea beans matured all at once and they were all harvested at the same day.

At germination, I observed about 98- 99 per cent germination, the seeds were so viable, the farmer who himself is a graduate of agriculture from the Federal University of Abeokuta said.

Due to the spacing method adopted on the 200g of seeds he was given, he explained that the cost of weeding was minimal, insect pest control on the farm too was minimal, and it made the use of insecticides more efficient and effective.

Bamigbola Kehinde, OSSADEPs agric extension deputy director in Iwo, who coordinated and monitored the farmers that planted the Bt cowpea seeds in the state, said during the monitoring and evaluation phase of the crop, they noticed that it was quite different from the varieties their farmers have been planting in the area of insect infestation.

If we dont spray the old varieties we have been planting 3-4 times, we may not be able to achieve a reasonable yield, but with the PBRC variety, even with no spraying, we achieved a good yield, the OSSADEP official said.

In the past two weeks, our researchers put questions on social media platforms including WhatsApp and Facebook asking Nigerians if they have been following the GMO debates; what they know about Bt Cowpea and whether GMO crops should be generally accepted as a solution to the countrys farming challenges.

Respondents are mainly civil servants and corporate workers who can be classified as the literate public.

About 70 per cent of over 200 respondents admitted they basically have no knowledge of what GMOs are all about. I dont even know what genetically modified crops are. I will have to google it, said Tega Okene, a loan company staff in Abuja.

As a medical practitioner, I know nothing about this subject. Oh God! exclaimed Bissallah Ekele, the Chief Medical Director, University of Abuja Teaching Hospital, Gwagwalada.

About 20 per cent who said they have basic information on the technology preferred natural crops and farming solutions. Their reasons differ but can be linked to rising safety concerns.

No (GMOs should not be accepted). I think its horrible and can be harmful to our biodiversity in the long run, Jessica Oduh, a journalist said. On the reason for her answer, she said, Monsanto is horrid. I have read several reports linking the companys products to health and environmental hazards.

Miss Oduhs reservations for Monsanto are not unfounded. The American agro-chemical and biotechnology company (acquired by German company Bayer in 2016) has over the years been engaged in controversial high-profile lawsuits over its products health and environmental effects.

Chinenye Nwabueze, a lecturer and media expert, believes several allegations and safety concerns about GMOs should not be treated with levity in Nigeria. Theres a sharp increase in the price of wheat and some other foodstuffs across the globe because of the Ukraine and Russia war. Both countries, which are the largest producers, stopped exporting. So, ask yourself, why cant they use GMO versions to solve the problem, he said.

The lecturer hinged his argument on the strong hostility GMOs are facing in many parts of Europe where the technology is perceived as very unfavourable due to a general lack of confidence and health concerns about the product.

Only 10 per cent of the respondents think GMOs should be accepted in Nigeria citing its usefulness in solving the countrys food crisis. Nigeria should accept GMO because it can prove food production although a lot of awareness and sensitization is needed to allay fears of safety concerns and instil confidence among about the crop, said Osita Onyeji, a Lagos-based banker.

Despite their irreconcilable difference, pro and anti GMO groups acknowledged the poor awareness of the technology among Nigerians and inadequate shelf labelling of GM in groceries has been argued to be an infringement on peoples right to know what they buy and consume.

Rose Gidado, director of OFAB agreed that there is still very little awareness on GMOs, attributing the situation to the fact that some of the farmers growing the crops are not lettered and funding challenges her organisation is facing.

Most of them (farmers) didnt go to school, we just give them the seeds and tell them that the seeds have been improved, she explained, adding that when you tell them GMO, theyve never heard about it, so I dont know how you expect us to go about it.

Usually, she said, when you give improved seeds to farmers you dont have to feed them with all the information, let them be the one to give you the feedback.

What we just need to do is to teach them those agronomic practices, even if you improve the seeds, if good agronomic practices are not put into use it will not work, Mrs Gidado said.

She said good farm management practices are critical that is why farmers are educated on how, when and at what stage to do what and what to achieve the best results.

However, she said the awareness level on GMOs among Nigerians is still very low because it is capital intensive.

Being a government agency there is paucity of funds. When we go to a media house, especially television, to sponsor a programme they will say N30 million and without the media we cannot go anywhere, but we are doing our best, she said.

HOMEF on its part says it agrees on the need for Nigerians to have knowledge of GMOs to make informed choices. For many years now, we have tried to sensitise the public of the safety concerns of GMOs and possible dangers of its introduction into our Environment and country, Mariann Bassey- Orovwuje, the Coordinator for Food Sovereignty Program for Friends of the Earth Nigeria and Africa and the Chair of the Agroecology and Land Working Group of the Alliance for Food Sovereignty in Africa (AFSA, said.

Whenever we carry out such awareness and sensitization workshops and visits to communities, we still hear people say they do not know what GMOs are. When it comes to BT Cowpea, I can categorically confirm that the awareness level is quite low. The terminology used BT Cowpea alone is misleading. Most people dont know it is the same thing as Beans.

For Mr Bassey of HOMEF, the fact that farmers do not know what they are given to plant and GMO promoters admitting to not providing sufficient information to Nigerians should be enough reason not to allow GMOs into the country.

Even if they go around the country and tell everybody about GM foods, when it gets to the market it will still mix up with organic products because it is almost impossible to label GMOs in Nigeria, he said.

We are in a situation where we are ambushed to eat what we know nothing about. It is the fundamental right of a consumer to know what he or she is consuming.

Edwin Kwaku, leader of Food Sovereignty Ghana (FSG), an anti-GMO group leading Ghanas battle against approval of GMOs said the poor awareness on GMOs is deliberate.

A lot of media has been compromised Nigerians are tough people everywhere in the world and if they really know the dangers of GMOs and why it should be rejected, they will kick against it, he said.

Nigerias Biosafety Management Agency NBMA has been inundated with accusations of handing a free pass to western companies bringing in GMOs into the country despite safety concerns and poor awareness of the technology in the country.

The NBMA Act is defective, according to Mr. Bassey, because its governing board is filled with GMO promoters such as NABDA and the Biotechnology Society of Nigeria.

The speed with which Nigeria is permitting GMOs is highly suspicious and offers no assurance that the government is concerned about safety and the preservation of our biodiversity, he said.

In 2016, NBMA allowed the first set of GMOs into Nigeria by issuing two permits for commercial release of GM cotton, and the confined field trial of GM maize to Monsanto.

The NBMA approved the glyphosate herbicide resistant maize despite safety concerns including the International Agency for Research on Cancer report that linked the active ingredient glyphosate to cancer.

But Monsanto had argued theres overwhelming weight of evidence against IARCs classification of glyphosate as a carcinogen.

Nigerias foremost investigative newspaper, PREMIUM TIMES in its Editorial of August 29, 2016, titled, The Growing Menace of the Monsanto-induced Pro-GMO Lobby in Nigeria, raised concerned about what it described as a determined march by Monsanto to impose GMOs into agricultural production in Nigeria.

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INVESTIGATION: In Nigerian communities, farmers growing GM crops know too little to make informed decisions - Premium Times

Albany NY, United States: Scientists need to perform intensive research and study to design a vaccine against particular microbes. This vaccine is based on the fundamental information such as how it infects the human or animal cell and what is the immune reaction of the infected cell. Researchers have developed different types of vaccines such as live attenuated vaccines, subunit vaccines, inactivated vaccines, conjugate vaccines, toxoid vaccines, DNA vaccines, and recombinant vector vaccines.

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In recent years, the recombinant DNA technology has been used to generate new vaccines. This technology has helped scientists to develop recombinant vector vaccines against various bacterial and viral diseases. Recombinant vector vaccines are similar to DNA vaccines; however, these consist of an attenuated viral particle or bacterium as a vector.

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Viruses adsorb on to a cell and inject their genetic material into them. Scientists have taken advantage of this viral nature and developed recombinant viral vector vaccines using attenuated virus as a carrier of the genetic material into the host cell. Recombinant vector vaccines have several advantages over other traditional vaccines. These vaccines closely mimic a natural infection caused by a particular microbe, thereby generating a good immune response against it. Recombinant vector vaccine strategy enables triggering of T- lymphocyte, and antigens, are thus presented to T- cell lymphocytes which generates a strong cell mediated immune response in the body against that particular antigen or microbe. Moreover, it reduces need of repeat dosage to treat a particular disease. Attenuated bacterium can also be used as an efficient vector to generate recombinant vector vaccines. In this case, genetic material is inserted into the bacterial vector, causing the bacteria to express the antigens of other microorganism onto its surface, generating an immune response. Strong research is being carried out to develop recombinant vector vaccines for rabies, HIV, and measles. Currently, adenovirus vectors, poxvirus vectors, and alphavirus vectors are extensively studied and used to prepare vaccines.

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Rapid development in molecular biology and genetic engineering is the key driver of the global recombinant vector vaccine market. The market is expected to show a rapid growth during the forecast period. However, substantial number of pharmaceutical challenges associated with the development of recombinant vector vaccines and stringent regulatory norms laid by the regulatory bodies is likely to restrain the market.

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The global recombinant vector vaccines market can be segmented based on type of vector, disease type, and region. In terms of type of vector, the market can be bifurcated into recombinant viral vector vaccines and recombinant bacterial vector vaccines. The recombinant viral vector vaccines segment holds the maximum share of the market. Based on disease type, the market can be segmented into vector vaccines used to treat various viral and bacterial infections. Recombinant vector vaccines are being developed to treat cancer.

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Geographically, the global recombinant vector vaccines market can be segmented into Europe, Asia Pacific, Latin America, North America, and Middle East & Africa. North America held a major share in 2016, owing to rise in technology advancements in molecular biology and genetic engineering. Increasing awareness, government initiatives, and availability of vector vaccines are expected to boost the growth of the market in Asia Pacific. The recombinant vector vaccines market in Europe is anticipated to grow during the forecast period owing to technological developments and increasing prevalence of infectious diseases.

Key players in the global recombinant vector vaccines market include Sanofi, Pfizer, Inc., Novartis AG, Neuron Biotech, Merck and Company, GlaxoSmithKline plc, CSL Limited, Biological E, and Bharat Biotech.

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Ive long lamented a certain blind spot among my fellow physicians and scientists, a problem that the COVID-19 pandemic has made even more painfully apparent to me. What Im referring to is our inability as a group to recognize when science is being distorted and thereby weaponized in order to become disinformation. This is not a new technique, but its been turbocharged and used more frequently and intensely than ever before. I was reminded of this by a recent Twitter thread, the first part of which I will cite here:

Naturally, antivaxxers have been spreading this study far and wide as yet more evidence that mRNA vaccines against COVID-19 are dangerous:

I could list many more such Tweets, as well as the study being shared this way on Facebook with similar messaging that its strong evidence that mRNA vaccines are dangerous and suppress the innate immune system, the spike protein is toxic, and large numbers of people are being harmed by themexactly as intended by the antivaxxers who wrote it. But is it evidence of any of this? I think that you know the answer. Rather, it is a prime example of what I now refer to as misinformation (or disinformation) by scientific review article (or, more accurately, a pseudo-review article). It appears to have all the trappings of science, but its speculation goes far beyond what the science will support, all in the service of promoting a certain narrative and providing what seems to be scientific support for a pseudoscientific conspiracy theory. Unsurprisingly, it worked, as its social media engagement demonstrates.

It is also true that Prof. Morris nailed it perfectly in the fourth Tweet in his series. This review article is almost entirely speculative. However, not having such a long history of examining antivaccine pseudoscience, he missed observing that the article is speculative in a deceptive manner that Ive seen many times before dating back to the Hannah Poling story in 2008, in which antivaxxers tried to rebrand autism as a mitochondrial disorder in which vaccines interacted with a metabolic disease to trigger autism, a narrative that functional medicine guru Dr. Mark Hyman echoed and that was still being promoted up to right before the pandemic. As a preview, Ill mention that other examples include Yehuda Shoenfelds ASIA diagnosis, the idea of molecular mimicry by HPV vaccines, and homologous recombinaltion tiniker (misspelling preserved from the original). Think of this long review as a Gish gallop disguised as a review article. There are lots of claims, all speculative, many for which the cited evidence is at best tenuous and often requires quite the leap to go from what the evidence finds about a process and how that process might be related to COVID-19 vaccination.

Combined with the speculative claims about biological mechanism is also an exercise in dumpster diving into the Vaccine Adverse Events Reporting System (VAERS) database in a manner very much like how Tracy Beth Heg and other COVID-19 contrarians did for myocarditis last summer in an echo of how Mark and David Geier did it 16 years ago trying to prove that mercury in the thimerosal preservative that was used in some childhood vaccines until around 2001-2 caused autism, other antivaxxers tried to link the H1N1 vaccine to miscarriages (sound familiar?), and how Stephanie Seneff used the same deceptive technique to try to demonstrate in 2012 that aluminum adjuvants in vaccines and exposure to acetaminophen caused autism. Since COVID-19 vaccines hit the scene in December 2020, weaponization of VAERS reports has been a constant among antivaxxers.

The last name I mentioned is important. Why? Because Stephanie Seneff is the lead author of the paper thats been going around. She was an antivaxxer before the pandemic who blamed vaccines and GMOs for autism; its not surprising that she pivoted to being anti-COVID-19 vaccines, although early in the pandemic she tried to blame glyphosate and e-cigarettes for COVID-19. (I kid you not.) Like many antivaxxers before and during the pandemic, she has no primary expertise in vaccines, infectious disease, public health, epidemiology, or any other relevant biomedical academic disciplines. Rather, shes a computer scientist at MIT, and her sole qualification (if you can call it that) is an undergraduate biophysics degree from the late 1960s. In addition to her history promoting antivaccine misinformation, she has also made some truly off-base proclamations over the last several years, including her prediction in 2014 that by 2025 half of all children born that year will be autistic. (Its 2022 now. Howd that prediction work out?) She even once claimed that GMOs can cause concussions.

Weve also met Peter McCullough before. Hes a cardiologist who has been promoting a narrative that COVID-19 vaccines are causing a holocaust for over a year now. Unsurprisingly, hes also promoted ivermectin as a near miracle cure for COVID-19. Basically, Dr. McCullough has become a major force in promoting COVID-19 pseudoscience, quackery, and misinformation and is frequently on the speakers list for COVID-19 denial rallies and events.

I was interested in the other two authors, Greg Nigh and Anthony Kyriakopoulous, as I didnt recall having heard of them before. Greg Nigh is listed as being affiliated with Immersion Health in Portland, OR. Surprise! Surprise! Immersion Health is a naturopathic oncology clinic:

Immersion Health opened its doors in 2014. Dr. Greg Nigh and Maria Zilka, the clinics founders, have collaborated on cancer treatment for 10 years. Immersion Health brings them together to offer intensive, comprehensive and individualized programs for the treatment of all types and stages of cancer. In addition to cancer care, Dr. Nigh offers the full range of primary care medicine, including functional lab testing and genetic polymorphism analysis.

Immersion Health was started as an intensive naturopathic oncology clinic. Dr. Nigh develops comprehensive and intensive treatment programs for all types and stages of cancer.

The cancer treatment approach at Immersion Health is unique, recognizing cancer as a metabolic disease. At Immersion Health we are delivering therapies that address all aspects of health and vitality, because long-term success against cancer depends on a strong immune system, low inflammation, ongoing detoxification, lifelong nutritional strategies, stress management, physical activity and much more. Immersion Health brings this all together into individualized treatment plans that optimize every individuals potential for recovery and ongoing wellness.

Naturopathy is quackery, and naturopathic oncology doubly so. Just peruse this blog for many, many examples. Unsurprisingly, naturopaths have pivoted to COVID-19 quackery. Of the group, Anthony Kyriakopoulous has the closest to what one might consider actual qualifications, working at the Nasco AD Biotechnology Laboratory, a lab in Greece described as a private research laboratory focusing on the discovery, development and thereafter clinical application of patented medicinal formulations to provide innovative technology against infections inflammation autoimmunity and cancer. He also appears to have some expertise in RNAs and inflammation, but, as I always say, if youre an expert in something but associate your name with cranks, quacks, and pseudoscientists like Stephanie Seneff, Peter McCullough, and Greg Nigh, that should be a major red flag that perhaps the expert has gone crank.

Of course, defenders of authors like these would call what I just wrote an ad hominem attack. Its not, really. It could be an ad hominem attack if the only reason I gave for their paper being wrong were because it was authored by them, but you know me better than that. My response to such a charge is always the same: Qualifications matter. Author history matters. All but one of the authors are utterly unqualified to write a review article like this, and the one who arguably does have some qualifications is not the first author or the corresponding author. That tells me a lot before I read beyond the abstract.

Finally, this is a long article. Thats why, unlike Prof. Morris, Im going to approach it more from the angle of disinformation and its similarities to previous papers like it before the pandemic than get into the weeds of each and every claim, especially given that he has provided a good blog post that does get into the weeds, some of which I will borrow from given that its impossible not to address some claims. Again, Prof. Morris was quite correct that the paper is largely speculative and doesnt cite a lot of primary evidence, but that very speculativeness is a hallmark of many prior antivax narratives that try to postulate a biological mechanism by which vaccines caused autism and all manner of other health issues dating way, way back. Similarly, the paper does a VAERS dumpster dive to try to lend credibility to its speculation.

One of the more interesting things, from a disinformation standpoint, is a figure right at the beginning of the review, described as a graphical abstract. When I first read the paper, I hadnt recalled seeing such a figure described thusly, but I did recall a number of figures from the past in which vaccines were inserted into metabolic and immune pathways to make a science-y looking diagram arguing how vaccines caused this problem or other. Lets take a look:

This graphical abstract looks so very, very scientific, doesnt it?

Lets look at the actual written abstract and compare:

The mRNA SARS-CoV-2 vaccines were brought to market in response to the public health crises of Covid-19. The utilization of mRNA vaccines in the context of infectious disease has no precedent. The many alterations in the vaccine mRNA hide the mRNA from cellular defenses and promote a longer biological half-life and high production of spike protein. However, the immune response to the vaccine is very different from that to a SARS-CoV-2 infection. In this paper, we present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites. We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bells palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis. We show evidence from the VAERS database supporting our hypothesis. We believe a comprehensive risk/benefit assessment of the mRNA vaccines questions them as positive contributors to public health.

I will concede that the immune response to the vaccine is likely different than the immune response to a SARS-CoV-2 infection, but not in the way described in this paper that implies that its just as bad or worse than the immune reaction to infection. The authors claim that the mRNA vaccine initiates a set of biological events that are not only different from that induced by infection but are in several ways demonstrably counterproductive to both short- and long-term immune competence and normal cellular function but, as Prof, Morris notes, they self-cite to do it:

A preprint has revealed a remarkable difference between the characteristics of the immune response to an infection with SARS-CoV-2 as compared with the immune response to an mRNA vaccine against COVID-19 (Ivanova et al., 2021).

Where does that link go? Straight back to this review article! (If you dont believe me and think that I altered the link, just go to the article itself and click on the link.) The actual paper is a preprint from August that appears to be still a preprint, and the interesting thing about it is that the paper demonstrates a good thing about COVID-19 mRNA vaccines, namely:

In COVID-19 patients, immune responses were characterized by a highly augmented interferon response which was largely absent in vaccine recipients. Increased interferon signaling likely contributed to the dramatic upregulation of cytotoxic genes in the peripheral T cells and innate- like lymphocytes observed in COVID-19 patients. Analysis of B and T cell repertoires revealed that while the majority of clonal lymphocytes in COVID-19 patients were effector cells, in vaccine recipients clonal expansion was primarily restricted to circulating memory cells. Taken together, our analysis of immune responses to the mRNA vaccine reveals that despite the lack of dramatic inflammation observed during infection, the vaccine elicits a robust adaptive immune response.

Then Seneff et al. also claim:

All of these observations are consistent with the idea that the anti-COVID-19 vaccines actively suppress type I IFN signaling, as we will discuss below.

More likely, its consistent with the vaccines not stimulating type I IFN signaling and all the inflammation that comes with it, which is a good thing. After all, thats what you want from a vaccine: a robust immune response that doesnt come with all the inflammation caused by the infection but still ends up producing memory cells that can be reactivated by contact with the provoking antigen! After all, the main issue is that actual infection is, well, infection. It stimulates the immune response as the virus is replicating freely and damaging cells, thus leading to inflammation, both specific to the infection and nonspecific. Also, the mRNA vaccines induce muscle cells to make the SARS-CoV-2 spike protein, which is the protein that binds to the ACE2 receptor on human cells and allows the virus to enter them. Thats the target of the immune response. Infection would be expected to result in an immune response to more viral proteins than just the spike protein.

Just the introduction is full of additional misrepresentations, for example:

Since long-term pre-clinical and Phase I safety trials were combined with Phase II trials, then phase II and III trials were combined (Kwok, 2021); and since even those were terminated early and placebo arms given the injections, we look to the pharmacosurveillance system and published reports for safety signals. In doing so, we find that that evidence is not encouraging. The biological response to mRNA vaccination as it is currently employed is demonstrably not similar to natural infection. In this paper we will illustrate those differences, and we will describe the immunological and pathological processes we expect are being initiated by mRNA vaccination. We will connect these underlying physiological effects with both realized and yet-to-be-observed morbidities. We anticipate that implementation of booster vaccinations on a wide scale will amplify all of these problems.

This is a deceptive misrepresentation of what actually happened, something I wrote about over a year ago. Basically, once the vaccines were released under an emergency use authorization (EUA), there was no way to guarantee that subjects in the placebo arm of the large clinical trials carried out by Pfizer and Moderna for their vaccines would not simply get vaccinated. After all, the EUA had been issued, and doctors and the government were doing everything they could to encourage people to be vaccinated against COVID-19. The unblinding and crossover of the clinical trials was actually the ethical thing to do, even if it complicated the long term safety surveillance. Once a vaccine demonstrated to be effective and safe has been released to the public, regardless of the regulatory mechanism under which it was approved, it was, quite simply, unethical to continue to withhold the vaccine from the subjects in the placebo group. This is an issue that antivaxxers and those who enable them have long distorted; so its not at all surprising that Seneff et al. are doing it too.

They also parrot a number of common anti-COVID-19 vaccine talking points that Ive discussed both here and at my not-so-super-secret other blog:

The mRNA vaccines manufactured by Pfizer/BioNTech and Moderna have been viewed as an essential aspect of our efforts to control the spread of COVID-19. Countries around the globe have been aggressively promoting massive vaccination programs with the hope that such efforts might finally curtail the ongoing pandemic and restore normalcy. Governments are reticent to consider the possibility that these injections might cause harm in unexpected ways, and especially that such harm might even surpass the benefits achieved in protection from severe disease. It is now clear that the antibodies induced by the vaccines fade in as little as 310 weeks after the second dose (Shrotri et al., 2021), such that people are being advised to seek booster shots at regular intervals (Centers for Disease Control and Prevention, 2021b). It has also become apparent that rapidly emerging variants such as the Delta and now the Omicron strain are showing resistance to the antibodies induced by the vaccines, through mutations in the spike protein (Yahi et al., 2021). Furthermore, it has become clear that the vaccines do not prevent transmission of the disease, but can only be claimed to reduce symptom severity (Kampf, 2021a). A study comparing vaccination rates with COVID-19 infection rates across 68 countries and 2947 counties in the United States in early September 2021, found no correlation between the two, suggesting that these vaccines do not protect from spread of the disease (Subramanian and Kumar, 2947). Regarding symptom severity, even this aspect is beginning to be in doubt, as demonstrated by an outbreak in an Israeli hospital that led to the death of five fully vaccinated hospital patients (Shitrit et al., 2021). Similarly, Brosh-Nissimov et al. (2021) reported that 34/152 (22%) of fully vaccinated patients among 17 Israeli hospitals died of COVID-19.

Note the appeal to natural immunity (more properly called postinfection immunity or infection-induced immunity) above all, even though evidence is increasingly showing that natural immunity wanes as well and likely doesnt last much longer than vaccine-induced immunity. Moreover, the rise of the very variants that can evade prior immunity (Delta and Omicron) demonstrates that natural immunity can be bypassed by the virus almost as easily as vaccine-induced immunity. In addition, as any immunologist knows, antibody levels dont stay high forever after an infection or a vaccine. If that were the case, our blood would soon become a viscous glop of nothing but high levels of antibodies to previously-encountered antigens to which the immune system had responded. Its the development of memory cells, which can quickly be reactivated to produce antibodies when the immune system encounters an antigen again, that matter more. As for disease transmission, once again we see the Nirvana fallacy, in which anything less than 100% safety and efficacy implies that a treatment or vaccine is worthless, in this case that the vaccine doesnt prevent transmission. Actually, it does; its just not 100% effective and the effect, like that of the vaccine, does wane. The way to look at it is that the vaccines are less good at preventing infection and transmission than they are at preventing serious disease and death, not that they dont prevent transmission or infection at all. Lets just say that it doesnt look good when the evidence cited for the claim that the vaccines dont prevent transmission is a study as risibly awful as Subramanian and Kumar.

The rest of the paper before the VAERS dumpster diving reminds me of something I used to do with a friend of mine back when we were in junior high. It probably wont surprise readers to learn that, even at that tender age, I was a science geek (also just what was considered in the mid-1970s to be just a geek). There were times when my friend and I would wildly speculate about science that we only slightly understood, wondering if there were a link between this idea and other ideas, whether genetic engineering were possible (remember, this was the 1970s), and a whole bunch of what ifs. It was fun at the time, even though our knowledge of science was junior high science geek level, and such flights of speculative fancy no doubt increased our enthusiasm for science, to the point where both of us became doctors, me a surgeon-scientist and my friend a pathologist.

Lets just say a lot of this paper reminds me of those days, stringing ideas together without much in the way of good evidence, and saying What if? Of course, junior high science geeks ultimately grew up to study serious science, but this paper strikes me as being similar to what we did, the exception being that we were engaging in our speculative arguments innocently. This paper is not so innocent, even if it seems to have applied a gloss of scientific findings to the same sort of speculative flights of fancy. For instance, the authors try to claim that this suppression of IFN responses predisposes people to cancer:

Both IFN- and IRF9 are also apparently necessary for the cancer-preventative properties of a fully functional BRCA2 gene. In a study presented as an abstract at the First AACR International Conference on Frontiers in Basic Cancer Research, Mittal and Chaudhuri (2009) describe a set of experiments which show for the first time that BRCA2 expression leads to increased IFN- production and augments the signal transduction pathway resulting in the complexing of IRF9, STAT1 and STAT2 described previously. Two years prior, Buckley et al. (2007) had established that BRCA1 in combination with IFN- promotes type I IFNs and subsequent production of IRF7, STAT1, and STAT2. Thus, the exceedingly important cancer regulatory genes BRCA1 and BRCA2 rely on IRF7 and IRF9, respectively, to carry out their protective effects. Rasmussen et al. (2021) reviewed compelling evidence that deficiencies of either IRF7 or IRF9 lead to significantly greater risk of severe COVID-19 illness. Importantly, they also note that evidence suggests type I IFNs play a singularly important role in protective immunity against COVID-19 illness, a role that is shared by multiple cytokines in most other viral illnesses including influenza.

Being a breast cancer surgeon, I know a fair amount about BRCA2 and BRCA1, as well as their functions preventing cancer. Also note how Seneff et al. cite a 13-year-old abstract about BRCA2 and IFN- production. If I were reviewing the paper, I would have asked: Wheres the published paper? I would have noted that, given that this is a 13-year-old finding, it should have found its way into the scientific literature by now. A quick search of PubMed for anything published together by the two authors who published the abstract about BRCA2 showed me that apparently these results never made it into a full paper. Even if they had, the abstract itself simply showed that the BRCA2 tumor suppressor was needed for breast cells to make IFN-. In other words, the finding is basically irrelevant to COVID-19 vaccines or any other vaccines. If the result held up, it would really only show that the need for BRCA2 to produce IFN- in breast cells might be relevant to the cancer suppressing function of the gene. In fairness, more recent data suggest a link between BRCA2 deficiency and immune signaling, but that leaves the question: Why did Seneff et al. so selectively cite a 13-year-old abstract?

Then theres this:

A recent early-release study has found that the mRNA in the COVID-19 vaccines is present in germinal centers in secondary lymphoid tissue long after the vaccine is administered, and that it continues to synthesize spike glycoprotein up to at least sixty days post-vaccination (Rltgen et al., 2022). This suggests that immune cells taking up the mRNA in the arm muscle migrate into the lymph system to the lymph nodes, presumably in order to expose B-cells and T-cells to the toxic antigen. The persistence of the mRNA in the lymph nodes and its sustained synthesis of SARS-CoV-2 spike glycoprotein reflect the clever engineering involved in the mRNA technology, as described above.

Imagine that! The antigen sticks around in the lymph nodes to stimulate an immune response! How horrible!

This paper is rife with such odd citations about biological processes, many unrelated to vaccination or infection, all marshaled in the service of trying to convince you that mRNA-based COVID-19 vaccines cause harm. Indeed, the authors even invoke codon usage, fear mongering about coinfection with other viruses, and supposed molecular mimicry (although they dont use the term) of the spike protein because of its supposed similarity to various important human proteins. There are mentions of microRNAs (something in which I have some expertise as well) and exosomes, as well as metabolism. Rather than go through them all (or even a lot of them), Im going to quote Prof. Morris:

This very long review article presents many details about various biological pathways, most related to cancer, but their links to mRNA vaccines are almost wholly speculative. In some cases, they link to other vaccines, old mRNA technology, or COVID-19 infection, but are not directly linked to mRNA vaccines.

In fact, so much of their evidence is from papers on severe COVID-19 infections, not vaccination, much of the evidence in this article might be better suited to a paper pointing out potential downstream dangers of severe COVID-19 infections than on trying to raise alarm about mRNA vaccination.

A number of places in the article seem to make stronger statements linking mRNA vaccines to some of these processes, but they self-cite a previous review article by senior author McCullough and do not reference any primary biological research making these connections.

They suggest connections of these mechanisms to various anecdotal case reports for herpes zoster reactivation, liver damage, optic neuropathy, T cell lymphoma progression, Hepatitis C reactivation, events not yet confirmed to be related to mRNA vaccination.

The paper amounts to laying out a series of hypotheses about mechanisms of harm that may come from mRNA vaccines. Hypothesis generation is a valuable exercise, including in this context of understanding downstream biological effects of vaccination that might induce harm.

However, not all hypotheses are equally supported. Some are well-girded in direct evidence from relevant studies, while others are more speculative and extrapolate principles from other settings, e.g. SARS-CoV-2 infections or other injected vaccines, as done here.

Again, Prof. Morris is entirely too kind. I would put it a different way. This review is the scientific equivalent of a form of what the kids like to call shitposting a bunch of low-quality provocative assertions on social media designed to provoke a visceral reaction. In this case, the visceral reaction intended is disgust and fear of mRNA-based COVID-19 vaccines. Prof. Morris is, of course, quite correct when he identifies the purpose of this torrent of speculation as shifting the burden of proof, with the authors claiming that their wild speculation must be taken seriously by scientists and their proposed harms be investigated right now, rather than presenting anything resembling actual compelling evidence why their ill-formed hypotheses should be taken seriously in the context of what is already well-established about human biology and immunology:

Challenging public health institutions to disprove the assertions made by this article, rather than taking responsibility to validate them or urge other scientists to do so, is a bold move. This type of statement in which one makes a claim and presumes it should assumed true unless other scientists can disprove it, is the classic shifting the burden of truth trick. A scientist proposing a hypothesis has the burden of validating it; it is not the responsibility of the scientific community to disprove it, and the hypothesized claim certainly does not have the benefit of presumption of truth unless disproven. This is a common tactic used by many during the pandemic.

In addition, this whole review article is one big Gish gallop, in which a torrent of questionable claims is made in an attempt to overwhelm the reader with the quantity of claims, with no regard for their quality. Ive been told that its impossible to Gish gallop in a paper, because one has the time to read and address every claim, but one could easily spend 20,000 words or more to address each and every claim in this review. Thats the point. Thats why Im trying to point out how this review is similar previous efforts and to put it into context with disinformation in general

The purpose of a paper like this is to put a seemingly scientific gloss on speculative scientific bafflegab in which the various concepts are at least six degrees of separation away from any biological framework having anything to do with vaccines. Scientists with the requisite expertise recognize this handwaving as the crap that it is, but those without the requisite expertise dont. Even some doctors and scientist without the proper specialized expertise wont recognize it for what it is, disinformation.

After all the scientific shitposting (if youll excuse the term), Seneff et al. then try to make all their speculation and JAQing off sound plausible by appealing toyou guessed it!VAERS.

Lets take a look at the VAERS reports examined by Seneff et al. The easiest thing for me to do is to quote the Tweets. For example, heres Table I, which Seneff attribute to inflammation:

Indeed. There is no known mechanism by which the tiny amounts of spike protein that make it into the bloodstream after vaccination could injure the olfactory bulb and cause anosmia (loss of the sense of smell), which also happens to be a well-known symptom of COVID-19 infection itself. Theres also quite a bit of evidence that it is direct infection of the cells in the olfactory bulb with SARS-CoV-2 that is responsible for anosmia. If theres a symptom of the virus that wed expect the vaccine not to cause, it would be anosmia.

Lets just say that this passage from the review should tell you all you want to know about it. I laughed out loud when I read it:

There were nearly 100,000 cases of nausea or vomiting, which are common symptoms of vagus nerve stimulation or damage (Babic and Browning, 2014). 14,701 cases of syncope linked to COVID-19 vaccines represented 96.3% of all cases of syncope, a well-established feature of vagus nerve dysfunction (Fenton et al., 2000).

People passed out after vaccination, and that must mean the vaccine was somehow hurting the vagus nerve? Seriously, I can only laugh. Lots of people faint after blood draws or shots; its a common reaction, particularly in certain populations. Its the same sort of claim that, you might remember, antivaxxers made about the HPV vaccine because so many teenage girls faint after receiving it, except that they at least had a more plausible mechanism than that the vaccine somehow messed up the vagus nerve. Dont get me wrong. Stimulation of the vagus nerve can cause fainting. Thats why they call it a vasovagal reaction. However, in general its pain or fear that results in that stimulation.

Since Im a cancer doctor, Ill mention this one too:

The authors even admit:

Cancer is a disease generally understood to take months or, more commonly, years to progress from an initial malignant transformation in a cell to development of a clinically recognized condition. Since VAERS reports of adverse events are happening primarily within the first month or even the first few days after vaccination (Rose, 2021), it seems likely that the acceleration of cancer progression following vaccines would be a difficult signal to recognize. Furthermore, most people do not expect cancer to be an adverse event that could be caused by a vaccine, and hence they fail to enter a report when cancer develops shortly after vaccination.

They should have stopped right there, but they couldnt resist continuing:

However, as we have outlined in our paper, if the mRNA vaccinations are leading to widespread dysregulation of oncogene controls, cell cycle regulation, and apoptosis, then VAERS reports should reflect an increase in reports of cancer, relative to the other vaccines, even if the numbers are small. The experiment demonstrating impairment of DNA repair mechanisms by SARS-CoV-2 spike protein in an in vitro study provides compelling evidence that the vaccines could accelerate the rate of DNA mutations, increasing cancer risk (Jiang and Mei, 2021).

Again, Seneff et al. were right at first before they went wrong. Cancer is the culmination of a process that, in general, takes years, from the initial insult that resulted in cellular transformation to the development of a cancerous tumor detectable by symptoms, physical exam, or screening tests. As I discussed before when antivaxxers did a similar thing with another database to try to blame cancer on COVID-19 vaccines, even after radiation exposure from an atomic bomb, the increased risk of cancer from such a carcinogenic exposure is too long for this to make sense. For leukemias, its about two years before the earliest signals can be seen. (The vaccines have only been widely available for less than a year and a half). For solid cancers, the lag time is about 10 years. The increased risks from radiation from the atomic bombs dropped on Hiroshima and Nagasaki, especially those for solid cancers, were most easily detected after 30 years and remain over a persons lifetime. Basically, the authors concede (sort of) that its too early to detect an increased risk of cancer from COVID-19 vaccines but then pivot to a hand wave that says, But look at our mechanisms! Never mind that the mechanisms were highly speculative to begin with and unproven.

I could go on about the VAERS section, but Prof. Morris did a fine job with it already, and I only wanted to harp on the cancer part because Im a cancer surgeon and biologist myself. Remember, VAERS is a database to which anyone can contribute anything as a report of an adverse event after vaccination, and antivaxxers have been gaming VAERS since the 1990s. Its a problem that has only gotten so much worse since the pandemic hit. VAERS is useful as an early warning system, but only if you know how to use it, a skill that involves knowing the base rate of the adverse events reported in the population.

I started this post by pointing out how bogus scientific review articles are a long-time favorite technique of spreading antivaccine misinformation. In fact, they are a favorite tool of spreading science denial of all kinds, particularly of evolution and climate science, but I know antivaccine science denial better than I know those other forms, which is why Ill stick to a couple of examples from the past. One dates back to 2011, when a Helen Ratajczak published an article in the Journal of Immunotoxicology titled Theoretical aspects of autism: CausesA review. This review article was picked up by Sharyl Attkisson, an antivax reporter who has now become an all-around conspiracy theorist and COVID-19 denialist, to promote the claim that vaccines cause autism. As an aside, Attkissons report produced the still hilarious misspelling that those of us who have been following the antivaccine movement a long time still bring up to this day, homologous recombinaltion tiniker. She meant to write homologous recombination, the process by which DNA with a highly homologous (similar) sequence to a sequence in the genome can integrate itself in that spot, but the misspelling lives on.

Basically, Ratajczaks claim was that DNA from the fetal cells used to manufacture some vaccines could get into the brain, undergo homologous recombination with the DNA of neurons, and produce foreign proteins (fusions of self proteins plus the fetal protein) that would result in autoimmunity and cause autism. Thats it. Thats the idea, which is incredibly implausible. To do what Dr. Ratajczak claims, the minute amount of human fetal DNA in a vaccine would have to:

Thats leaving aside the issue of whether autoimmunity in the brain or chronic brain inflammation is even a cause of autism, which is by no means settled by any stretch of the imagination. In fact, quite the opposite. Its not at all clear whether the markers of inflammation sometimes reported in the brains of autistic children are a cause, a consequence, or merely an epiphenomenon of autism. In other words, Dr. Ratajczaks hypothesis is incredibly implausible on the basis of what we know about molecular biology and human biology. Its not quite homeopathy-level implausible, but nonetheless quite implausible.

Her review was useful in that it also listed another favorite hypothesis of antivaxxers from a decade ago, namely deficiencies in metal metabolism that predisposed children to autism when they were exposed to mercury (from vaccines, of course):

Defective metallothionein might be responsible for the greater amount of blood mercury found in autistic children compared to neurotypical controls (Desoto and Hitlan, 2007; Geier et al., 2010). Metallothionein plays an important role in the development and continued function of the immune response, in neuronal development, and in the detoxification of heavy metals. Many classic symptoms of autism may be explained by a metallothionein defect, including gastrointestinal (GI) tract problems, heightened sensitivity to toxic metals, and abnormal behaviors. Porphyrinuria in children with autism is considered a marker of heavy metal toxicity (Geier and Geier, 2006a; Nataf et al., 2006, 2008; Rossignal, 2007; Geier et al., 2009). Individuals with severe autism had increased mercury-intoxication-associated urinary porphyrins (Geier et al., 2009).

Again, there was (and still is) no good scientific evidence to support the plausibility of these hypotheses. I could list a whole slew of papers trying to link various metabolic processes to autism via vaccine injury but will spare you. Ill also note that the Hannah Poling case was a huge driver of papers claiming to link mitochondrial disorders to autism via vaccine injury. The idea was that mitochondrial disorders make a child susceptible to neurologic damage due to fevers due to vaccines. But you know what causes fevers more effectively? Actual infections! Thats why it is highly recommended that children with mitochondrial diseases receive the full slate of childhood vaccines. And dont even get me started on another highly speculative mechanism how vaccines could supposedly cause autism known as microcompetition.

One thing that distinguishes Ratajczaks review from that of Seneff et al. is that Ratajczak discussed a number of non-crank hypotheses with actual science behind them (e.g., the association of certain gene mutations, increased paternal age, and more) along with her vaccine-autism causation pseudoscience, the better to disguise the antivaccine pseudoscience. Seneff et al. could have learned from that, but apparently they didnt. The idea was the same, though, to get a review article into the scientific literature to provide scientific-sounding highly speculative talking points that antivaxxers could use to blame autism on vaccines, exactly the same thing that Seneff et al. accomplished.

Finally, Seneff et al. was published in Food and Chemical Toxicology, a journal by a large scientific publishing house, Elsevier. I note that its the same journal that published Gilles-Eric Sralinis awful GMO study that was ultimately retracted. More importantly, it is a journal that had no business publishing a review article like this, given that its not a journal dedicated to vaccines, infectious disease, epidemiology, or other relevant specialties. It is a toxicology journal, but its a stretch for it to cover alleged adverse reactions from COVID-19 vaccines and a whole lot of Gish galloping about potential biological mechanisms for those complications. One has to wonder why Jose Luis Domingo, who is listed as the editor who handled this review, let it pass and why the peer reviewers didnt reject it.

I think I know why. The most charitable explanation is likely twofold. First, COVID-19 articles, particularly ones claiming adverse reactions from vaccines, bring clicks, and editors want to publish them. More importantly, though, an explanation that doesnt require any sort of conflict of interest or nefarious motivation on the part of the journal editor is that neither journal editors nor peer reviewers recognize misinformation and disinformation. They therefore reviewed Seneff et al. as though it were a serious attempt at a scientific review, not recognizing the Gish galloping. Even giving them that benefit of the doubt, though, I have a hard time not faulting them for failing to recognize the highly speculative nature of the claims, the obvious misuse of VAERS, and the even more highly selective citation (and self-citation) of papers that dont really support the hypotheses proposed, at least not without a lot of contortions of logic and biology. These were not subtle flaws.

As professions, we scientists and physicians could in the past be blissfully oblivious to misinformation and disinformation. No longer. If we dont get our acts together to recognize them, the result will be many more reviews like this weaponized to attack public health. Actually, its already too late, but maybe the deluge can be at least reversed and the cranks forced to publish this nonsense where they used to: In bottom-feeding journals and on their own websites, rather than in Elsevier journals.

The rest is here:
Scientific review articles as antivaccine disinformation - Science Based Medicine

Job Description

Are you a biomedical researcher motivated to pursue an outstanding career in cancer research with a focus on organoid research?

Cancer will affect more than 1 in 3 Singaporeans. At the Cancer Science Institute (CSI), our mission is to be at the global forefront of research to overcome this scourge. Our innovative international faculty, cutting-edge facilities, supportive working environment and competitive package together enable each of our staff to realize their maximum potential.

We now seek a Research Assistant/ Associate to join the team of Prof. Ashok Venkitaraman. This is an exciting opportunity to work closely with a world-leading cancer researcher to undertake pioneering research on the role of genome instability in human carcinogenesis (eg., see Venkitaraman Science (2014) PMID:24675954 and Venkitaraman DNA Repair (2019) PMID:31337537).

The role will provide expertise in the establishment, genetic manipulation and maintenance of human and murine organoid cultures as well as design/ perform and analyse work within the project parameters.

Duties And Responsibilities

Research:

Lab Management:

Qualifications

Knowledge of:

Ability to:

Covid-19 Message

At NUS, the health and safety of our staff and students are one of our utmost priorities, and COVID-vaccination supports our commitment to ensure the safety of our community and to make NUS as safe and welcoming as possible. Many of our roles require a significant amount of physical interactions with students/staff/public members. Even for job roles that may be performed remotely, there will be instances where on-campus presenceis required.

In accordance with Singapore's legal requirements, unvaccinated workers will not be able to work on the NUS premises with effect from 15 January 2022. As such, job applicants will need to be fully COVID-19 vaccinated to secure successful employment with NUS.

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Research Assistant, Cancer Science Institute job with NATIONAL UNIVERSITY OF SINGAPORE | 290831 - Times Higher Education

New Delhi: For centuries, humans have searched for ways to protect each other against deadly diseases. Immunisation has a long history, from experiments and taking chances to a global vaccine roll-out in the midst of an unprecedented pandemic.

Vaccines provide everyone a chance at a fulfilling life, and have helped keep people healthy for more than two centuries, be it the very first vaccine developed to protect against smallpox to the latest vaccine used to prevent severe cases of Covid-19.

The world has witnessed the unparalleled impact of vaccines on health and well-being, ever since the first vaccine was developed for smallpox in 1796. For centuries, people worldwide have been vaccinated. This led to the eradication of smallpox and driving down of wild polio cases to an all-time low.

Every year, World Immunization Week is celebrated worldwide in the last week to April, to highlight the importance of vaccines and how immunisation helps protect people from vaccine-preventable diseases.

Immunisation is one of modern medicine's greatest success stories, and prevents deaths every year in all age groups from diseases like diphtheria, tetanus, pertussis (whooping cough), influenza, and measles. The Centers for Disease Control and Prevention (CDC) engages globally to support the development and implementation of vaccination strategies and programmes that can prevent more than 25 vaccine-preventable diseases.

Immunisation currently prevents four to five million deaths every year, according to the World Health Organization (WHO).

From smallpox to Covid-19, here is a story of how vaccines have saved lives for centuries.

The basis for vaccination began in the year 1796. English doctor Edward Jenner noticed that milkmaids who contracted cowpox were protected from smallpox, and also knew about variolation, which was one of the first methods for controlling smallpox. Named after variola virus, the causative organism of smallpox, variolation was a process during which people who had never contracted smallpox were exposed to material from smallpox sores called pustules by scratching the materia into their arm or inhaling it through the nose. Fewer people died as a result of variolation, compared to the number of deaths that would have occurred if smallpox was acquired naturally.

Jenner guessed that exposure to cowpox could be used to provide protection against smallpox. He tested his theory on James Phipps, the nine-year-old son of his gardener.

Jenner inoculated material from the cowpox sore on the hand of milkmaid Sarah Nelmes into the arm of Phipps, and exposed him several times to the variola virus. Surprisingly, Phipps never developed smallpox.

After conducting more experiments, Jenner published his treatise "On the Origin of the Vaccine Inoculation", in 1801, in which he summarised his discoveries and expressed hope that the "annihilation of the smallpox, the most dreadful scourge of the human species, must be the final result of this practice."

Vaccine was gradually accepted, and replaced the practice of variolation. In the 1800s, the virus used to make smallpox vaccines changed from cowpox to vaccinia virus.

The Kingdom of Bavaria was one of the first countries to introduce compulsory vaccination according to Jenner's method. On August 26, 1807, the Royal Bavarian Government Gazette published a decree "concerning smallpox vaccination to be introduced by law in all provinces."

In the Kingdom of Bavaria, vaccination certificates were issued after successful vaccination against smallpox. These certificates were usually simple slips of paper. The only exception was a certificate issued in Graz, Styria, in 1855, which depicts Jenner, milkmaids, children, and a cow.

ALSO READ | World Immunization Week 2022: Google Shares One Of The Earliest Vaccination Certificates Ever. Know The Disease It Was For And All About It

The vaccination set for smallpox was made in Tuttlingen, Germany, and was manufactured between 1920 and 1930. It consisted of a knife, which was sterilised before being dipped into the vaccine. Then, the vaccine was inoculated into the upper arm of a person with two small cuts.

A few days after the vaccination, a small pustule was formed on the upper arm, which scarred characteristically, indicating that the vaccination was successful.

Due to the success of vaccination, smallpox was eradicated, and no cases of naturally occurring smallpox have occurred since 1977.

On May 8, 1980, the 33rd World Health Assembly, the decision-making body of the World Health Organization, declared the world free of smallpox. This was almost two centuries after Jenner hoped that vaccination could annihilate smallpox.

For his contribution to Immunisation, Jenner is also known as the "father of immunology".

Imvanex is the vaccine currently approved for vaccination against smallpox, and is developed by Bavarian Nordic based on the Modified Vaccinia Ankara virus strain. The vaccine can be injected subcutaneously and is approved for inoculation in people with immune deficiencies. Despite the fact that smallpox is considered eradicated, samples of the virus are still stored in research laboratories in the United States and Russia.

European typhus fever, also called "spotted fever" and "ship fever", is different from typhoid fever. For generations, the disease was the scourge of armies, and still flourishes in Poland, Russia, and the Balkans. Spotted fever is caused by a bacterium called Rickettsia prowazeki, which dwells in the intestines of filthy little insects. The virus is transmitted by lice and fleas.

The infection does not occur when a louse bites; rather, the bacteria are found in lice faeces, which enter the host's body through the bite wound.

Professor Rudolf Weigl of the University of Lemberg, Poland created a vaccine for spotted fever. The vaccine did not provide full immunity against the disease, but substantially reduced the symptoms.

The vaccine provided protection against severe forms of the disease for at least one year. Weigl obtained his vaccine from infected lice intestines.

According to Google Arts and Culture, Weigl managed to save the lives of thousands of people, including Polish University professors and Jewish citizens, by classifying their dangerous work as "louse-feeders" as "important to the war effort". Louse-feeders were human sources of blood for lice infected with spotted fever, which were then used to research possible vaccines against the disease. This was a job in interwar and Nazi-occupied Poland, at the Lviv Institute for Study of Typhus and Virology, and the associated Institute in Krakow, Poland. Weigl and his wife were some of the earliest lice-feeders.

Typhoral was a solid vaccine used for oral inoculation against typhoid fever in the 1940s.

Typhoral contained killed typhoid bacteria Salmonella typhi and paratyphoid bacteria Salmonella enterica, in order to stimulate the immune system to produce antibodies.

The vaccine provided protection for about six to 12 months.

Currently, a live vaccine containing non-disease-causing Salmonella typhi bacteria is used for oral typhoid vaccination.

People were vaccinated against Polio for the first time in West Germany, in the year 1956. A vaccine developed by US physician and immunologist Jonas Salk was used.

The vaccine, called Virelon, contained killed poliovirus. However, only a few people agreed to get themselves vaccinated against Polio. Salk became a national hero when he alleviated the fear of polio with his vaccine, approved in 1955. However, Salk's vaccine was not the last polio vaccine. Albert Sabin, a Polish-American researcher, introduced an oral vaccine in the United States in the 1960s which replaced that of Salk.

Sabin's live vaccine was available on sugar cubes. Its motto was "oral vaccination is sweet!".

Between 1963 and 1999, Sabin's vaccine largely replaced Salk's vaccine everywhere in the world, according to the Smithsonian National Museum of American History. However, the live virus in the vaccine occasionally became strong enough to cause the actual disease, because of which Salk's killed-type vaccine replaced the live-type vaccine in the US.

Tetanus, caused by Clostridium tetani, is usually fatal. However, it is the toxins produced by the bacteria, rather than the bacteria themselves, which primarily cause symptoms, according to an article published by Smithsonian institution. The same is true for diphtheria and pertussis. Currently, tetanus, diphtheria, and pertussis can be addressed by a single, combined vaccine.

A vaccine to prevent tetanus, called tetanus toxoid, was introduced in 1924. Tetanus toxoid is an inactivated form of the toxin, which teaches the body to recognise and produce antibodies against the toxin, but is not able to damage the body itself. The vaccine was not frequently used until World War II, during which it became one of the routine vaccinations given to all American soldiers.

The pure toxin is converted into a non-toxic form called toxoid by treatment with formaldehyde. The toxoid is adsorbed to a mineral carrier such as aluminium hydroxide, and serves as a vaccine.

Due to routine vaccination in the United States, death from tetanus has become rare. However, it is important to repeat a vaccination booster every ten years to keep that

immunity. People who do not contract tetanus can be treated with a modern form of antitoxin, called tetanus immune globulin.

Each winter season, the World Health Organization selects different virus strains which are likely to be responsible for influenza illnesses in a particular hemisphere during the respective flu season.

The Influsplit Tetra vaccine is indicated for the prevention of the genuine viral flu or influenza in adults and children aged six months and above, caused by the two influenza A virus subtypes and the two influenza B lineages. These strains are contained in the vaccine.

A single prick can protect one against mumps, measles, and rubella, when they are inoculated with a combination vaccine.

The MMR (mumps, measles, rubella) vaccine "Priorix" is a combination vaccination.

Combination vaccines were first used in the 1970s. The protective effect is not compromised, and fewer additives make them better tolerated. Also, only one appointment with the doctor is necessary.

Other combination vaccines include those for tetanus, diphtheria, pertussis, and polio, or Hepatitis A and B.

German Nobel laureate Harald zur Hausen had proved that infection with human papillomaviruses (HPV) or wart viruses plays a decisive role in the development of cervical cancer or cervical carcinoma. The discovery was important because it led to the development of HPV vaccines.

Available since 2006, HPV vaccines specifically protect against certain sexually transmitted human papillomaviruses.

Gardasil 9 is a new nine-drug vaccine which provides protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The United States Food and Drug Administration (FDA) approved Gardasil 9 in 2014.

Gardasil 9 is produced through genetic engineering and contains only non-infectious viral envelopes.

Ervebo vaccine is an Ebola vaccine that prevents Ebola caused by the Zaire ebolavirus. It is manufactured by Merck. Ebola is one of the deadliest viruses in the world.

The genetic material for a vaccine antigen is inserted into a carrier virus, which is then injected into the Ervebo vaccine. The protein of the virus' genetic material is incorporated into the surface of the vector, which is then introduced into the body of the human.

The proteins trigger the production of antibodies in the vaccinated person. Ervebo is the first new vector technology-based vaccine to be approved.

Pfizer-BioNTech is an mRNA-based vaccine developed in the year 2020 by German pharmaceutical company BioNTech in collaboration with US pharmaceutical company Pfizer against SARS-CoV-2, or the novel coronavirus.

Since naked mRNA is physically and thermally unstable, it cannot reach the site of action without being degraded. In order to avoid this and to make sure that the vaccine is effective, the mRNA is packaged inside lipid nanoparticles called lipid beads. When these are injected into the body of a person, the cells take up the lipid beads, and produce the S protein, or the spike protein on the genetic material.

The immune system recognised the spike protein as foreign, stimulating the production of protective antibodies.

ALSO READ | World Immunization Week 2022: Know The Week's Significance & What The Theme 'Long Life For All' Means

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World Immunization Week 2022 | From Smallpox To Covid-19: How Vaccines Saved Lives For Centuries - ABP Live

(Photo : Skye Yayoi Drynan)

While investors who make strategic investments in undervalued companies can transform said business as well as their own portfolio, investors who make strategic investments in companies with an ethical purpose can change the world. The investors that history remembers kindly are not the ones with the highest yields; history looks fondly on the investors who use their economic power to help bring positive to individuals and society at large. Investors who are looking to make a difference have a wide array of industries and companies on a moral mission to choose from.

Biotechnology is a thriving industrywith a plethora of innovative companies using cutting-edge technology to solve the most complex and important health issues of our time. Of course, as the COVID-19Pandemic spread throughout the world over the last few years, investments and innovations in biotechnology are more important now than ever.

Skye Drynanis an investor, entrepreneur, inventor, and thought leader pioneering multiple market-disrupting projects in the biotechnology space, helping people live happier and healthier lives. Drynan has a long history in both investment and biotechnology, always betting on herself. Whether it's excelling on the boys' soccer team as a teenager, becoming the first person in the history of Putnam Investments to transition from their operations division to their investment division, or asking to become the Global Head of Health Care at Credit Suisse at just 27 years old, Drynan knows she can overcome any challenge and reach any goal she sets her mind to.

As a female who has risen to the top of multiple male-dominated industries, Drynan understands what it is like to be underestimated and put in a box. In addition to breaking into multiple 'boys clubs,' Drynan is constantly misunderstood by her peers due to her knowledge about and success in a wide variety of fields. As an inventor with 7 original issued bra patents plus an issued seamless shopping patent called UWIN (U Want It Now), a fashion enthusiast and entrepreneur, and a successful biotech investor who can speak technically about the industry, the depth and width of Drynan's knowledge is unparalleled. Drynan likes to joke that she is just as "comfortable on the red carpet as she is in the boardroom and as a keynote speaker." In addition to the hard work necessary to rise to the top of any field as a technical investor and entrepreneur, Drynan has unfortunately experienced personal and familial health issues over the course of her life. These personal experiences inform Drynan's interest in and excitement about biotechnology.

After graduating from Wellesley and becoming the first person in the history of Putnam Investments to transition from a call center to their investment division, Drynan continued to overachieve and outperform her peers. In her first year in the investment division, Drynan took another risk, speaking truth to power about an investment decision when other employees in her cohort stayed silent about Eurotunnel and Canary Wharf's untenable debt structures. Ultimately being proved right -- helping the company minimize its risks and maximize its returns -- Drynan finished at the top of her class.

Eventually, Drynan would take her newly honed investment skills in order to serve and honor her love for biotechnology; Drynan went to work for Margaret Smith just at the beginning of the genomic boom. After getting special permission to take a genetic engineering course at Harvard and spending two nights a week at MIT labs, Drynan quickly built her technical understanding of the science powering the most important biotechnology innovations. This allowed Drynan to work for a small sell side boutique company in New Jersey building her book of business with some of the largest players in the industry. Her short report on Schering-Plough paved the way for Drynan to join Credit Suisse Asset Management.

Drynan had to prove herself once again, working hard to prove to the CEO that she deserves the job as the Global Head of Healthcare. Drynan bet on herself and took a risk yet again by asking the CEO of Credit Suisse Asset Management to become the Global Head of Health Care. Impressing him with her presentation, her confidence in herself, and her desire to make successful biotechnology investments in companies that were poised to make a positive difference in the world, Drynan secured the job. Stating that he probably would not have given her the job unless she asked, Drynan's willingness to bet on herself bore fruits once again.

This gave Drynan even more experience and legitimacy to take a position at Capital Group, working with some of the most innovative and life-saving biotechnology companies in the world over the last 12 years. During this time, Drynan made partner, became widely recognized as a thought leader in the industry, and has worked with companies to drive the science forward in genetic engineering, cellular therapies, cancer cures, viral treatments, and vaccines.

Recently, Drynan finally made the jump to be her own boss, investing in biotechnology ventures as well as starting her own fashion and tech enterprise. Using her 7 original issued bra patents (+2 patents pending) and 1 issued tech patent (+1 patent pending) , Drynan is now the CEO of House of Skye, a high-tech, high-function, high-fashion brand. Drynan's unique ability to combine the best of fashion and technology has sparked the interests of Carrie Underwood, Lady Gaga, Paris Hilton, Gwen Stefani, Kevin Jonas, Kelly Mi Li and more - all of whom have been seen in House of Skye.

As a thought leader and market-moving investor in biotechnology, we are excited to see how Skye Drynan continues to improve the world with her strategic biotechnology investments as well as her new entrepreneurial projects.

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Nanotechnology is a vast field which includes a range oftechnologies at the nano scale, being applied to pharmaceuticals,biotechnology, genomics, neuroscience, robotics and informationtechnologies and more. In India it holds importance particularly inthe nanobiotech & nanomedicine segments. The commencement ofnanobiotechnology in India has unfurled a series of questions andchallenges in terms of intellectual property protection. Therefore,it is of immense importance to explore whether the Indian PatentSystem presents suitable atmosphere for appropriate patentprotection in India.

Like any new technology, nanobiotechnology also createsopportunities as well as challenges in adapting the patent regimeto its particular context. This article strives to highlightproblems and challenges faces by Nanobiotechnology invention owingto their multi-disciplinary character, crosssectoral applications,broad claims, as well as difficulties in fulfilling thepatentability criteria of novelty, non-obviousness, and industrialapplication.

Challenges for Nanobiotechnology Invention under Indian PatentsAct 1970

Nanotechnology is a novel and revolutionary branch oftechnology, where reduction in size has demonstrated magnificentresults. Intersection with the field of biotechnology has givenrise to nanobiotechnology. Involvement of living forms and thepotential to meet human necessities have raised issues that areunique to nanobiotechnology. It has emerged as an interdisciplinaryfield of research and development that integrates engineering,physical sciences, and biology through the development of verysmall physical and biological devices using biomimetically inspirednanofabrication techniques1 .

Following challenges are faced under Indian Patent regime inPatenting of Nanobiotechnology Inventions:

According to section 3(d) of the Act, if there is vagueness inthe "particle size", it attracts the possibility of beingincluded in non-patentable subject matter. In case ofnanobiotechnology, the newness of technology is significantlyderived from the reduction in size. The primary ambiguity is lackof a universal definition of nanobiotechnology. The word"nano" encompasses inventions of 100nm in size orsmaller. Pharma industry is likely to be the most beneficiarysegment from nano biotechnology aided research. Nano particleefficacy or accuracy of methods using nano particles for drugdelivery is significantly ruled by particle size which may vary asdifferent drugs are effective with different particle size. Forthis reason, fixing a size limit of 100 nm may rule out thepatenting of such particles under the "nano"regime.5 There is lack of a standard for determinationof the efficacy and quantification of enhancement of efficacy inthe Indian patent regime.

Under this regime, nanotech invention would remain nonpatentableunless the particle size differed in its properties have showedenhanced efficacy. Patentability of drugs would revolve around thereduction in particle size to certify better efficacy, suchcontraventions with provision 3(d) is likely to occur. For example,Abbott Pvt. Ltd. sold an HIV drug Kaletra under brand name"Alluvia". To overcome the storage problems of the drug,Abbott claimed a heat-stable form of the same drug. Apre-opposition was filed by the organization, 'Initiative forMedicines, Access and Knowledge,' under section(d) of thePatents Act 1970.6

Utility requirement is crucial for nanobiotechnologybasedinventions. Nano biotechnology falls under the class of"unpredictable" arts like biotechnology. There is thepossibility of huge variation in the laboratory results andauthentic results when technology such as nanobiotechnology is putto use. In the laboratory stage, it is not possible to determinethe possible impact of external factors on products born out of atechnology. Inoperability of such products may render themnon-patentable as they would fail to comply with the utilityrequirements.7

In addition, the problem-solving approach applied in both Europeand India would render them as not being inventions (thus renderingthe problem insolvable). The case of EMI Group North America Inc vCypress Semiconductor Corp8 provides a better insightinto the requirement. The applicant claimed a patent for aninvention that lacked utility.

The Nanobiotechnology patent can be sought over the process ofpreparing the nanoparticles; the process of transfer of nanoparticles into the patient's body; the medical devices usedetc.9 Here significant question is the distinctclassification of methods as medicinal, surgical, curative,prophylactic, diagnostic and therapeutic and the subject matterthat each of them cover. It is argued that exempting medicalmethods from the purview of patentability is on the one hand, infavour of public policy, whereas allowing patents in this fieldwould draw unwarranted ethical, moral and practical problems andmay also fail to fulfil the industrial applicability criteria.

The problem in the present perspective is whether methods usingnanoparticles constitute diagnostic, surgical or therapeuticmethods. Amendments to the Indian Patents Act 1970, sec 3(i) can beimported from the European jurisdiction which has proposedsignificant amendments to their provisions similar to the IndianPatents law, regarding medical methods. Many of the technologiesbeing currently developed blur the line between non-patentablemethods for treatment and diagnostics practiced on the human bodyon one side and patentable products (substances or compositions)and apparatus used in such activities on the other. Some of theseimportant developments in diagnostics and treatment operate totallyin vitro, others entirely in vivo, some have a combination ofphases in vitro and in vivo, posing patentability questionsconcerning the patentability exception for Methods for treatmentand diagnostic (Hosseini et al., 2011; Daneshyar et al.,2006)10.

Followings are some examples of Nanobiotechology inventionsemployed as drug delivery system in medical methods for treatmentand diagnostic purposes:

Nanoparticles due to their small size have proved to be moreefficient, target specific, water soluble and stable tools in drugdelivery compared with the conventional routes of drugadministration. For decades pharmaceutical sciences have been usingnanoparticles to reduce toxicity and side effects of drugs. Thistechnology raises issues which are in disagreement withintellectual property rights protection and non-commercial laws(such as the environmental laws). In the absence of consonantpatent law provisions, nanotechnology is facing challenges withrespect to the criteria of novelty, inventive step, being capableof industrial application and eligibility of subject matter undersection 3 of the Indian Patents Act 1970.

Nanobiotechnology inventions have generated technologicalrevolution and emerged as a key technology for economic developmentin the twentyfirst century. The use of eco marks on nanobiotechnology products are proposed to ensure environmental safetyand consonance. This would further assist in dealing with thechallenges discussed in the nanobiotechnology products Since patentlaw is technology-specific, providing guidelines to examiners forassessment of patent applications is a good practice and should beencouraged as it would aid in the issuing of better qualitynanobiotechnology patents.

1 Daneshyar SA, Kohli K and Khar RK (2006) Biotechnologyand intellectual property. Sci. Res. Essay. 1, 020-025

2 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

3 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp.

4 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

5 Hosseini et al., 2011; Daneshyar et al.,2006

6 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

7 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

8 "Intellectual Property Rights of Nanobiotechnologyin Trade Related Aspects of Intellectual Property Rights Agreement(TRIPS)" Vol. 6, 5664, 2012, Journal ofBionanoscience

9 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

10 Hosseini SJ, Esmaeeli S and Ansari B (2011) Challengesin commercialization of nano and biotechnologies in agriculturalsector of Iran. Afr. J. Biotechnol. 10, 6516-6521.; Daneshyar SA,Kohli K and Khar RK (2006) Biotechnology and intellectual property.Sci. Res. Essay. 1, 020-025.

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Patenting Of Nanobiotechnology Inventions: Exploring The Challenges Under The Indian Patent Law - Intellectual Property - India - Mondaq