Category Archives: Corona Virus

In March 2020, just as COVID-19 cases began to surge in Boston, Massachusetts, Esther Freeman noticed something peculiara deluge of people with discoloured toes requesting appointments. Freeman, director of global health dermatology at Massachusetts General Hospital, had seen these kinds of toes before. The itchy red and purple patches are a classic sign of chilblains, a skin condition that typically appears in cold weather. But usually, she would see one or two cases each winter. Suddenly, I was seeing 15, 20 patients a day, she says. Intriguingly, the surgeseen by physicians around the globeseemed to coincide with the rise of the COVID-19 pandemic.

Yet, when physicians examined people with what the media began calling COVID toes, most didnt test positive for a coronavirus SARS-CoV-2 infection. Scientists were stumped, and have been looking for answers ever since.

The latest study, published on 25 February, is an immunological deep dive, examining 21 people who developed chilblains during the early months of the pandemic in Connecticut. Although the results dont rule out a direct connection between COVID-19 and chilblains, the authors couldnt find any immunological evidence of a past SARS-CoV-2 infection in 19 of those people. The report adds to the argument by some researchers that COVID toe could have been caused by something unrelated to the virus. For instance, it might have arisen from people in lockdown being at home, not wearing shoes and socks, says Jeff Gehlhausen, a dermatologist and immunologist at Yale School of Medicine in New Haven, Connecticut, and first author of the study.

Still, the results raise some very interesting questions that deserve further study, says Freeman, who was not involved in the research. For instance, the study doesnt exclude the possibility that people exposed to the virus could have fought it off using an innate immune responsea first-line defence that would not prompt the body to produce detectable antibodies and T-cells against SARS-CoV-2. So for now, she adds, the mystery remains.

How chilblains arise isnt entirely clear. We think of it as a cold-weather-related injury, says Patrick McCleskey, a dermatologist and researcher at Kaiser Permanente in Oakland, California. We always see some amount of chilblains in the winter, and then it goes down in the summer. Researchers think that the cold probably leads to a restriction in blood flow, causing some cells to die and kicking off an inflammatory process. The purple or red patches that appear on toes (and sometimes fingers, ears or noses) can be itchy, tender or, in some cases, downright painful.

Most of the people in the latest study developed COVID toes between April and May 2020, when COVID-19 cases surged in Connecticut. About one-third reported having some symptoms of COVID-19 before developing the condition, and one-third reported that they had been in contact with a person confirmed or suspected to have been infected with SARS-CoV-2.

The researchers used a variety of methods to look for antibodies and T-cells specific to the coronavirussigns of the body having whats called an adaptive immune response to a pathogen. These people were months past the onset of their chilblains, so their immune systems would have had plenty of time to respond to SARS-CoV-2 if they had been infected. But the team picked up signs of a past infection only in two people, one of whom had initially tested positive.

Many groups have tested people with chilblains for SARS-CoV-2 antibodies, but nobody had looked really into this hypothesis about the T-cell response, Freeman says. The team did a fantastic, really extraordinary job. But she emphasizes that the study is smalland therefore not necessarily generalizableand that much larger epidemiological studieshave shown a connection between chilblains and SARS-CoV-2.

Dermatologist Thierry Passeron, at Cte dAzur University in Nice, France, still thinks COVID toes are triggered by the virus. His team foundthat people who developed chilblains during the pandemic showed evidence of a strong innate immune response. The researchers posit that many people with pandemic chilblains clear the virus in this way, so very few develop antibodies, he says.

Previous studieshave examined whether people with chilblains had been infected with SARS-CoV-2 by taking tissue biopsies and staining the samples with a dye that identifies parts of the virus. Gehlhausen and colleagues tried the stain and found that it stuck to some of their tissue samples. But they also tested the stain on random tissue samples collected before the pandemic, when the virus was not in circulation, and found that it also marked some of those. Our study suggests that there may be a lack of specificity in that staining, Gehlhausen says.

With the link between COVID-19 and chilblains still in question, some researchers point to the lockdown theorythat people spent more time at home barefoot early in the pandemic and got cold feet, literally. Or perhaps all the media coverage of COVID toes led to more people than usual seeking medical attention for the problem.

For Freeman, the case is not yet closed. On one hand, she has seen patients who developed chilblains, justifiably, after walking in flip flops during a snowstorm. On the other hand, she has seen people who test positive for SARS-CoV-2 and then develop chilblains with no other obvious explanation.

The debate has become strangely polarizing, Gehlhausen says. But the hypotheses are not mutually exclusive. Its possible that all these things are true, he says. I am not on any team.

Its also possible the problem might be fading. Were still seeing patients with new chilblains, but it seems to be kind of back to the old background rate, says Yale dermatologist William Damsky, an author on the paper.

In the end, the issue makes for an intriguing scientific debate, but the answer isnt likely to alter how dermatologists treat patients, McCleskey says. Irrespective of whether a person had COVID-19, chilblains generally go away on their own in two or three weeks.

Honestly, I think maybe we can chill out about chilblains, he says.

This article is reproduced with permission and wasfirst publishedon March 162022.

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Are 'COVID Toes' Actually Caused by the Coronavirus? - Scientific American

A coronavirus testing site this month, outside a Hong Kong residential building under lockdown.Credit...Billy H.C. Kwok for The New York Times

Hong Kong said that more than one million people in the city of 7.5 million had tested positive for the coronavirus since the beginning of the pandemic, a worrying milestone for a city being battered by an extraordinarily lethal Omicron wave.

Hong Kong health officials said in a news conference on Friday that they had recorded 20,082 daily new cases and 206 new deaths, bringing the cumulative totals to more than 1,010,000 cases and more than 5,000 deaths.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

While other places in Asia like China, South Korea, Thailand and Vietnam are experiencing similar case waves driven by Omicron, Hong Kongs death rate is high, far outstripping that of mainland China, which has reported a total of about 4,600 deaths in a population of over 1.4 billion. Almost 95 percent of the citys deaths have come in the past 30 days, government data show.

Hong Kong was once viewed as a world leader in controlling the coronavirus crisis. But despite limits on public gatherings, restrictions on nighttime dining and mask mandates, a wave of Omicron cases that began late last year has overwhelmed its health care system, leading to bodies of the dead being piled up in hospitals.

In the past two weeks, Hong Kong has recorded about 65 percent of cases that it has ever had, government data show. Experts have said that figure is most likely an undercount. Using models, researchers at the University of Hong Kong estimated this week that at least 3.6 million people had been infected. Up to 4.5 million people may get the virus before the current outbreak ends, they added.

The outbreak involves the BA.2 subvariant of Omicron, which is more transmissible than Omicrons first version, BA.1, though not necessarily more virulent. Researchers in Britain and Denmark have found that BA.2 is no more likely to cause hospitalizations, but studies elsewhere are ongoing.

Other factors in Hong Kongs surge are also at play: The city is densely populated, and has a low vaccination rate among those 70 and older and residents of nursing homes. Its success in keeping the virus at bay until recently has also left many residents without any enhanced immunity.

Hong Kongs government is caught between the surging cases and deaths, pressure from Beijing for mass testing and lockdowns, and pandemic fatigue among residents. On Thursday, Carrie Lam, the citys chief executive, said at a news conference that she would move up the review of its current measures planned for April 20 to as soon as next week and reconsider its flight bans, compulsory testing and mandatory quarantines for travelers. I have a very strong feeling that peoples tolerance is fading, she said.

Hong Kongs case data included results from rapid antigen tests, officials said, which the government has accepted in lieu of P.C.R. test results since last month to expand testing capacity. Residents who test positive with rapid antigen tests have not had to seek confirmation with P.C.R. tests. But the government has also asked them to self-report their infections, or face legal consequences. Those who receive a positive result from a rapid antigen test may be randomly requested to be administered a P.C.R. test, officials said.

At a news conference on Friday, Ms. Lam underscored the urgency of reporting home tests to health authorities. If there are people blatantly refusing to comply, then isnt it incumbent upon the law enforcement body to do something? she said.

Johns Hopkins Universitys Center for Systems Science and Engineering, which has supplied the raw numbers for Our World in Data and The New York Timess coronavirus world map, has reported fewer cases than the Hong Kong government.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

The difference is because the center has not been including results from the citys rapid antigen tests in its total, but in an email on Friday, it said it intended to incorporate them in the future.

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Covid News: N.Y.C. Reports Spread of BA.2 Version of Omicron - The New York Times

President Biden participating in a virtual meeting with Prime Minister Micheal Martin of Ireland in the Oval Office on Thursday.Credit...Doug Mills/The New York Times

President Biden canceled his face-to-face meetings with Prime Minister Micheal Martin of Ireland on Thursday after the prime minister received a positive result on a coronavirus test during a gala event in Washington on Wednesday night that both men attended.

Daniel Mulhall, Irelands ambassador to the United States, confirmed the positive test early Thursday, complicating the prime ministers plans to spend the day with Mr. Biden for traditional St. Patricks Day celebrations.

Mr. Biden and Mr. Martin instead met virtually on Thursday morning, with Mr. Biden seated near a television monitor showing Mr. Martin, with a bowl of shamrock on a coffee table. The president said he was deeply sorry for the inconvenience for the virtual format.

White House officials said that Mr. Biden, who is 79 and has been vaccinated and boosted, was not in close contact with Mr. Martin during Wednesdays gala, which the Centers for Disease Control and Prevention defines as being within six feet of someone for at least 15 minutes. Jen Psaki, the White House press secretary, said that Mr. Biden is tested weekly for the coronavirus, and that his last test was on Sunday.

We, of course, abide by what the recommendations and advice are of his medical doctor, she said at a press briefing on Thursday. And if that would be to do increased testing, we would certainly do that. But he does not feel that is necessary at this point in time based on these recent contacts.

The prime ministers test result came amid a burst of infections among public officials in Washington in recent days. At least nine Democratic members of Congress tested positive this week after a party retreat and late night voting last week. Douglas Emhoff, the husband of Vice President Kamala Harris, also tested positive this week, as did former President Barack Obama.

White House officials have downplayed the recent spate of cases, noting that the overall rate in Washington is still extremely low. Ms. Psaki said on Thursday that that the new Omicron subvariant, known as BA.2, has been circulating around the country for some time, and the administration was monitoring cases in Europe and in China. New U.S. cases have plummeted from the height of the Omicron surge.

We expect some fluctuation, especially at this relatively low level, Ms. Psaki said, adding that the country is in a better position to manage the pandemic.

It is not gone, and it means we still need to continue to take steps we can to fight the virus, she said.

400% of last winters peak

Mr. Mulhall said on Twitter that he had accepted a leadership award for Mr. Martin on Wednesday at the gala for the Ireland Funds in Washington, an event that Mr. Biden and Speaker Nancy Pelosi also attended.

I filled in for the Taoiseach after he tested positive for #Covid19, he wrote, using the Irish word for the countrys leader. I wish the Taoiseach well for his recovery.

The speakers office confirmed that Ms. Pelosi, who is vaccinated and boosted, had tested negative on a P.C.R. test on Thursday morning, and would continue regular testing and to follow C.D.C. guidelines, though it was not clear which ones. It was unclear whether the Attending Physicians Office considered Ms. Pelosi, 81, to be a close contact.

Ms. Pelosi, who was photographed sitting next to Mr. Martin during the gala, appeared at her weekly news conference on Thursday, adding that she was tested nearly every day. Mr. Martin remained masked until food was served, she said, and was pulled aside during the appetizer course about his positive test.

Were very, very sad that on St. Patricks Day, the Taoiseach has this diagnosis, she said at her indoor news conference, where she removed her mask to speak and take questions. We wont be able to have the benefit of the honor of his presence.

A scheduled lunch The Friends of Ireland Luncheon on Capitol Hill proceeded on Thursday, without Mr. Martin present. Ms. Pelosi addressed the room, where lawmakers sat at round tables, while introducing Mr. Biden, who sat on a stool a few feet away. Neither wore a mask, and there were few face coverings in the room.

America has been blessed by Irish children, and one of those Irish children is now the president of the United States, Ms. Pelosi said, just before the shook hands and he took the lectern. Mr. Biden spoke, but did not stay for lunch.

Irish journalists traveling with Mr. Martins delegation reported that he had attended the early part of the gala, and photos from the event appeared to show him seated next to Ms. Pelosi.

A spokesperson for the Irish government said in a statement on Thursday that the prime minister had tested negative for the virus earlier on Wednesday and also on Sunday, before traveling to the United States.

His second test on Wednesday was administered after a member of the prime ministers delegation received a positive result on a test, the statement said.

Mr. Mulhall did not elaborate on whether Mr. Martin had symptoms.

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Covid News: 35 Companies Sign on to Produce Generic Versions of Pfizers Covid Pill - The New York Times

WELLINGTON, New Zealand

Samoa will go into lockdown starting Saturday as it faces its first coronavirus outbreak, two years into the pandemic.

The move comes after a woman who was about to leave the Pacific island nation tested positive for the coronavirus. It is the first time Samoa has found any unexplained cases in the community and likely points to an undetected outbreak that has been going on for days or even weeks.

A government report leaked online indicates that the woman had visited church services, a hospital, stores, a library and a travel agency since first feeling ill Saturday.

Samoa and several neighboring island nations were among the last places on Earth to avoid virus outbreaks. But the more transmissible Omicron variant has changed the equation, and one by one the island nations have witnessed infections.

Since the start of the year, Kiribati, Tonga, the Solomon Islands, the Cook Islands and American Samoa have all experienced their first big outbreaks.

John Fala, who runs a logistics company in Samoa, said it was inevitable that the coronavirus would eventually come to Samoa, a reality brought home for many when it began spreading in nearby American Samoa.

Weve had two years to prepare, Fala said. Now its finally here. Of course, there is going to be a bit of scrambling.

Starting Saturday, all schools will be closed, public gatherings will be banned, and all stores and other services will be shut down, except those considered essential. People are also required to wear masks.

There were reports Friday of panic-buying ahead of the lockdown.

Fala, who is vaccinated, said that his company is considered an essential service and that hes frantically trying to navigate the new rules to keep it operating.

The lockdown is initially scheduled to last through midnight Tuesday, but Fala expects it will be extended.

The father of three young children, Fala said his biggest concern is that unvaccinated children will catch the coronavirus. He said the nation of 200,000 had good rates of inoculation among adults but had only just begun vaccinating children ages 5 to 11 in the past week or so.

About 65% of all Samoans have had at least two doses of a COVID-19 vaccine, according to Our World in Data.

Samoan Prime Minister Fiame Naomi Mataafa told people about the positive case in a special announcement to the nation late Thursday. She said the infected woman was in isolation and that her movements and contacts with people were being traced.

Mataafa said officials wanted to do all they could to contain it from spreading rapidly.

Although our country continues to traverse through these difficult times, let us continue to trust in the Lord, Mataafa said in her announcement.

Samoa has had previous coronavirus scares and lockdowns after returning plane passengers tested positive while isolating, but had managed to avoid any community outbreaks until now.

Micronesia, the Marshall Islands and Nauru are among the few remaining Pacific island nations to have avoided Omicron outbreaks.

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Facing its first coronavirus outbreak, Samoa to go into lockdown - Los Angeles Times

Ian Sheer, a Keller Army Community Hospital at West Point nursing student, administers a coronavirus booster shot to Master Sgt. Jose Rivera of the 1179th Transportation Surface Brigade during a booster shot clinic at the U.S. Army Garrison Fort Hamilton, N.Y., on Feb. 24, 2022. (Connie Dillon/U.S. Army )

Stars and Stripes is making stories on the coronavirus pandemic available free of charge. See more storieshere. Sign up for our daily coronavirus newsletterhere. Please support our journalismwith a subscription.

WASHINGTON The Army has issued its first three separations for soldiers who refused to get their mandatory coronavirus vaccinations, the service announced Friday.

The Army is the last of the service branches to begin kicking out troops who do not get the shots. Technically, the three soldiers were separated for refusing a lawful order to receive the vaccine, according to the Army.

The announcement comes more than three months after the Armys deadline to receive the vaccine, and about six weeks after Army Secretary Christine Wormuth ordered service commanders on Jan. 31 to begin the process of involuntarily separating vaccine refusers as expeditiously as possible.

While the Army had not separated any soldiers until this week, the Army relieved six service leaders from command including two battalion commanders and issued 3,251 general officer written reprimands to soldiers for refusing the vaccination order.

Defense Secretary Lloyd Austin ordered all service members to receive the vaccine in August, but allowed each service to determine their own timelines.

Last week, the Army approved its first permanent religious waiver for the vaccine order. The service has granted one more as of Friday, according to an Army statement released Friday.

About 702 active-duty soldiers have been denied a religious exemption, while another 3,943 are awaiting decisions on their religious waiver requests.

The Army also has approved seven permanent medical exemptions to the vaccine, as of Friday. The service has denied 658 permanent waiver requests and another 692 are awaiting decisions.

Those denied exemptions to the Armys vaccine mandate have seven days to start the vaccination process or file an appeal of their denial before commanders are to begin the process of kicking them out, according to Wormuths January order.

Some 96% of the Armys about 486,000 active-duty soldiers have been fully vaccinated and another 1% were partially inoculated, the service said Friday. Those percentages remain unchanged from the previous week.

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Army kicks outs its first three coronavirus vaccine refusers - Stars and Stripes

All epidemics trigger the same dispiriting cycle. First, panic: As new pathogens emerge, governments throw money, resources, and attention at the threat. Then, neglect: Once the danger dwindles, budgets shrink and memories fade. The world ends up where it started, forced to confront each new disease unprepared and therefore primed for panic. This Sisphyean sequence occurred in the United States after HIV, anthrax, SARS, Ebola, and Zika. It occurred in Republican administrations and Democratic ones. It occurs despite decades of warnings from public-health experts. It has been as inevitable as the passing of day into night.

Even so, its not meant to happen this quickly. When I first wrote about the panic-neglect cycle five years ago, I assumed that it would operate on a timescale of years, and that neglect would set in only after the crisis was over. The coronavirus pandemic has destroyed both assumptions. Before every surge has ended, pundits have incorrectly predicted that the current wave would be the last, or claimed that lifesaving measures were never actually necessary. Time and again, neglect has set in within mere months, often before the panic part has been over. The U.S. funds pandemic preparedness like Minnesota snow, Michael Osterholm, an epidemiologist at the University of Minnesota, told me in 2018. Theres a lot in January, but in July its all melted.

Or, as it happens, in March.

This week, Congress nixed $15 billion in coronavirus funding from a $1.5 trillion spending bill, which President Joe Biden then signed on Tuesday. The decision is catastrophic, and as the White House has noted, its consequences will unfurl quickly. Next week, the government will have to cut shipments of monoclonal-antibody treatments by a third. In April, it will no longer be able to reimburse health-care providers for testing, vaccinating, or treating millions of uninsured Americans, who are disproportionately likely to be unvaccinated and infected. Come June, it wont be able to support domestic testing manufacturers. It cant buy extra doses of antiviral pills or infection-preventing treatments that immunocompromised people are banking on but were already struggling to get. It will need to scale back its efforts to improve vaccination rates in poor countries, which increases the odds that dangerous new variants will arise. If such variants arise, theyll likely catch the U.S. off guard, because surveillance networks will have to be scaled back too. Should people need further booster shots, the government wont have enough for everyone.

To be clear, these facets of the pandemic response were already insufficient. The U.S. has never tested sufficiently, never vaccinated enough people, never made enough treatments accessible to its most vulnerable, and never adequately worked to flatten global vaccine inequities. These measures needed to be strengthened, not weakened even further. Abandoning them assumes that the U.S. will not need to respond to another large COVID surge, when such events are likely, in no small part because of the countrys earlier failures. And even if no such surge materializes, another infectious threat inevitably will. As I wrote last September, the U.S. was already barreling toward the next pandemic. Now it is sprinting there.

The virus is moving too. Cases are shooting up across Western Europe, auguring a similar rise in the U.S., as has happened in every past surge. (A third of the CDCs wastewater sites have detected upticks in coronavirus samples this month, although such data are noisy and hard to interpret when levels of virus are low.) Meanwhile, mask and vaccine mandates are being lifted. Contact tracing and quarantine policies are being discontinued. The CDCs new guidelines recast most of the country as low risk and left the most vulnerable individuals with the burden of protecting themselves. Some experts supported the guidelines on the grounds that testing, treatments, and other defensive tools were availableand, as promised in Bidens recently unveiled national plan, would be strengthened even further. But those promises were always contingent on congressional funding; without it, those residual layers of protection evaporate too. For half a year, Biden, administration officials, and several prominent public-health voices have encouraged optimism because we have the tools to fight the virus. The first half of that catchphrase now seems doubtful.

As The Washington Post and others have reported, the funding meltdown occurred because Republicans were skeptical about the need for further COVID funding. Their counteroffer was to repurpose unspent pots of money that had already been set aside for state-level pandemic responses; Democrats refused, and coronavirus aid was omitted from the bill entirely. It is reasonable to ask for accountability in spending, but this particular line of reasoning is familiar. In 2016, Barack Obama asked Congress for $1.9 billion to fight Zika, but Republicans refused, arguing that such funds should be cannibalized from a pot that was set aside for the 2015 Ebola outbreak. In 2018, Donald Trump asked Congress to rescind $252 million that was leftover in that pot, which he billed as an example of irresponsible federal spending. In fact, those funds were an investment, left deliberately untouched so that the U.S. could more quickly respond to future outbreaks (such as the one that began in the Democratic Republic of the Congo exactly as Trump issued his call). The U.S. clearly grasps the concept of preparedness during peacetime: It spends at least $700 billion a year on its military, more than any other country. But when thinking about infectious diseases, vital preparations for the future are routinely seen as unnecessary excesses of the presenteven in the middle of a pandemic.

One could argue that such thinking reflects pragmatism rather than complacency. Budgets arent infinite, and countries face a multitude of pressing problems. If one threat goes away, doesnt it make sense to divert resources to others? This argument fails for three major reasons. First, and most obvious, the threat didnt go away! Even when the coronavirus reaches endemicity (which it very much hasnt yet), an endemic threat isnt one that can be ignored but one that must be managedwhich requires regular investment of the kind that Congress saw fit to deny. Second, preventing epidemics is far more cost-effective than dealing with their consequences, and allocating funds only when a threat is knocking on our door is economic folly.

Third, many of the measures that would make a difference against COVIDbetter ventilation, paid sick leave, equitable health care, a stronger public-health infrastructurewould also protect people from other diseases and health problems. In this respect, even the $15 billion that the White House asked for (and now wont get) is insufficient. And to consider such money as COVID funding is part of the problema misguided approach of tackling health problems one by one, instead of fixing the inequities that underlie them all.

These dynamics might occur for many of the same reasons that I identified in a recent article about why much of the U.S. has normalized so many COVID deaths. The virus is invisible. The ruin it inflicts is hidden from public view. The pandemic has gone on for two long years, turning tragedy into routine and breeding fatalism from failure. Older, disabled, poor, Black, or brown Americans, whose excess deaths were tolerated long before COVID, have borne the brunt of the pandemic, while privileged people have had the swiftest access to medical interventionsand have been quickest to declare the crisis over. A country that so readily forgets its dead is surely prone to also forgetting the lessons of the all-too-recent past, setting itself up for further failure in an all-too-imminent future.

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The COVID Funding Collapse Is a Disaster - The Atlantic

STATEN ISLAND, N.Y. Booster coronavirus (COVID-19) vaccine doses will no longer be required for New York State health-care workers, according to a recent report.

The New York State Public Health and Health Planning Council voted on Thursday to no longer require health-care workers to receive a COVID-19 booster, stated a report by WETM-18 News, in Elmira, N.Y. The change in policy needs to be added to the State Registry before it becomes effective, according to the media outlet.

Gov. Kathy Hochul first mandated the booster in January, citing the effectiveness of the vaccine mandate for keeping health-care workers safe.

Many health-care associations, hospitals and workers themselves spoke out against the mandate, saying it would lead to further staffing shortages. Some associations, like the Health Care Association of New York State, asked for a 90-day extension before the booster mandate went into effect.

To help protect some of our most vulnerable New Yorkers from COVID-19, today the Public Health and Health Planning Council (PHHPC) extended the original vaccination requirement for health-care workers that has remained in effect since last year and does not renew the booster dose requirement for health-care workers, the state Health Department said, according to the report.

In light of concerns about potential staffing issues, on Feb. 18, the New York State Department of Health announced it would not enforce the mandate requiring health-care workers get a COVID-19 booster shot. As a result of the health-care worker vaccine requirement, hospital workers and long-term staff have a completed vaccine series of 98 and 99 percent, respectively, the statement continued.

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Coronavirus booster to no longer be mandated for health-care workers, report says - SILive.com

WASHINGTON Over the past 10 months, as tens of millions of children and teenagers received the Pfizer-BioNTech vaccine, the companies main rival, Moderna, sat on the sidelines, its shot limited to adults.

But Moderna may now be poised for a comeback at a critical juncture in the nations vaccination campaign. The company is expected to send federal officials initial data this week on how well its coronavirus vaccine works for the nations youngest children.

About 18 million children under the age of 5 are the only Americans not yet eligible for vaccination. And while uptake for older children has been slow, many parents are still anxiously awaiting the chance to protect their babies, toddlers and preschoolers.

Moderna is going head-to-head with Pfizer-BioNTech for the opportunity to vaccinate this group, hoping it has found what some scientists are calling the Goldilocks dose: strong enough to offer lasting protection, but not so strong that it causes widespread worrisome side effects, such as high fevers.

Moderna has opted for a regimen of two doses at a quarter the strength of its adult dose for children under 6. Pfizer is expected to seek authorization next month for a three-shot regimen for children under 5, with doses one-tenth as strong as those for people aged 12 and up.

Moderna is also expected to release data soon from its clinical trial on the next age group up: children aged 6 to 11.

Dr. Yvonne Maldonado, a Stanford professor of pediatric infectious diseases and a lead investigator at the Stanford site of Pfizers pediatric vaccine trials, said new data from both Moderna and BioNTech in the coming weeks will offer critical insight into the effectiveness of their pediatric shots. She said researchers are watching carefully to see if Modernas stronger doses result in more robust immune responses than Pfizers shots have elicited in young children.

A series of new studies raising questions about how long Pfizers lower doses protect elementary-school-age children has piqued interest among federal scientists and vaccine experts in Modernas choices.

Dr. Ofer Levy, a pediatric expert at Harvard Medical School and a member of the Food and Drug Administrations independent vaccine advisory committee, said he thought Pfizer might have selected too low a dose for 5- to 11-year-olds in the understandable priority to maximize safety.

To date, Pfizer has been the only player in vaccinating younger Americans, winning authorization to vaccinate 12- to 15-year-olds last May, followed by 5- to 11-year-olds in October. Its authorization for adults also covers 16- and 17-year-olds.

Moderna sought authorization to vaccinate teenagers last June, but the F.D.A. delayed considering the request because of concerns about the risk of myocarditis, a condition involving inflammation of the heart that has been tied to both the Moderna and the Pfizer shots.

More than 22 million people in the United States under 18 are now fully vaccinated with the Pfizer vaccine, but uptake has been leveling off. Only roughly one in four children ages 5 to 11 are fully vaccinated, for example, even though shots have been offered to that group for more than four months.

But there is still a demand to protect the youngest children as more of the country unmasks, more parents return to workplaces and the summer travel season approaches.

Compared with adults, there is no question that in children the benefit of an effective vaccine is less, because fewer get really sick, said Dr. Eric Rubin, an infectious disease expert at the Harvard T.H. Chan School of Public Health and a member of an advisory panel to the Food and Drug Administration.

But it will benefit some individuals, he said. It will save some lives. According to the Centers for Disease Control and Prevention, 336 children in the United States under the age of 5 have died of Covid since the start of the pandemic.

Hopes that the youngest children would soon be covered surged last month after regulators pressed Pfizer-BioNTech to submit preliminary results from its three-dose trial. The F.D.A. wanted to get the vaccination campaign underway with two doses while awaiting final results on three.

March 18, 2022, 7:05 p.m. ET

But that effort collapsed when new data from Pfizer that encompassed more of the Omicron surge showed convincingly that two doses failed to protect adequately against symptomatic infection.

Now, more detailed results from Pfizers and Modernas trials are materializing at roughly the same time. And while neither company knows yet whether its vaccines will prove effective enough for the youngest age group, but both say their research shows they are safe.

We have not seen anything untoward right now, so we feel confident in the safety profile, Dr. Paul Burton, Modernas chief medical officer, said in an interview.

Amy Rose, Pfizers spokeswoman, has said that after careful research, Pfizer-BioNTech chose the safest and most tolerable dose for young children. The companies have said they are hopeful that a three-shot regimen will provide strong protection for children under the age of 5. Pfizer is testing a 10-microgram dose for 5- to 11-year-olds, a third of the adult and teenage dosing; and 3 micrograms for children under 5.

Moderna is proposing substantially higher dosing than Pfizer in all three pediatric age groups: 100 micrograms, the full adult dose, for those ages 12 to 17; 50 micrograms in children 6 to 11, and 25 micrograms in those under 6. Regulators are considered likely to review the firms data for all three age groups simultaneously.

We really stand behind those doses, Dr. Burton said. Although federal officials say both Pfizer and Modernas vaccines wane in potency over time, some studies of adults have suggested that Modernas protection holds up longer. I think it comes down to dose, Dr. Burton said.

He said initial results showed a 50-microgram Moderna dose prompted a robust immune response in children 6 to 11. While the overall number of infections was small, researchers hope that trial will help reveal how well the vaccine prevents illness, not just how high it boosts antibody levels.

Dr. Philip Krause, who recently retired as a senior vaccine regulator at the F.D.A., said the agency spent significant time last year worrying about the safety of Modernas vaccine for those under 18, with some studies showing a higher risk of myocarditis from the companys shot than from Pfizers.

The question is always: What is the dose that gives rise to an immune response that we think is likely to be protective? he said. You couldnt actually test to figure out the rate of myocarditis since its rare, but you could ask, What are we sacrificing in immune response by lowering the dose, and do we think thats important?

Partly because of concerns about myocarditis, the C.D.C. recently encouraged some people 12 or older, particularly boys and men between 12 and 39, to wait eight weeks between their first and second Pfizer or Moderna shots. Studies have shown that teenage boys and young men are most at risk of developing the side effect.

Dr. Burton said that overall the research had proved reassuring, including recent British data that showed myocarditis was very rare and typically mild in both Pfizer and Moderna recipients.

But Dr. Walid F. Gellad, a drug safety expert at the University of Pittsburgh, said it remained unclear whether Modernas higher dosing might elevate the risk of myocarditis in young children. The companys pediatric studies are most likely much too small to identify the risk of the side effect, he and other experts said.

Modernas new push also comes after several studies raised questions about the protection that two doses of Pfizer-BioNTechs vaccine provide for children 5 to 11. Researchers in New York States health department recently found that protection against infection from two doses faded significantly within weeks.

C.D.C. researchers separately found that during the Omicron wave, the effectiveness of two doses of the Pfizer shot against moderate forms of the disease in children ages 5 to 11 dropped significantly.

The studies have kindled a debate among vaccine experts about whether a stronger dose would have been better or whether those children need third doses. Booster shots are now authorized for everyone 12 and up. Pfizer expects results from its study of a three-dose regimen for the younger children next month.

Dr. Gellad said it was possible the Pfizer dose for 5- to 11-year-olds may have been too weak, but that scientists could not yet be certain. He said he expected regulators would be especially careful in considering higher doses for young children given the comparatively low risks of them catching Covid now and getting severely ill.

Amid all the questions, one thing is clear: The back and forth over which vaccine will be better for young children could discourage uptake.

Alison M. Buttenheim, a behavioral health expert at the University of Pennsylvania, said those considering vaccination found comfort in certainty. Otherwise, thats just going to pave the way to say, Im going to hold off, she said. A lot of people are uncomfortable with evolving science.

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Which Coronavirus Vaccine Will Work in the Youngest Children? - The New York Times

(The Hill) White House adviserAnthony Fauci is warning that COVID-19 infection rates are likely to rise in the next few weeks in the United States after their dramatic drop following the omicron variants rapid spread across the country.

I would not be surprised if in the next few weeks, we see somewhat of either a flattening of our diminution or maybe even an increase, Fauci said on theABC News podcast Start Here,ABC News reported.

Whether or not that is going to lead to another surge, a mini-surge or maybe even a moderate surge, is very unclear because there are a lot of other things that are going on right now, he added.

Cases have fallen heavily across the nation over the last two months, with the average number of new cases totally just over 30,000.

Faucis prediction is based on the United Kingdom, where cases have slightly started to go up, although their intensive care bed usage is not going up, which means theyre not seeing a blip up of severe disease, Fauci added.

The increase in cases comes as the BA.2 variant is seeing an uptick in the U.S., with Fauci predicting on the podcast the variant will overtake omicron in the future.

The U.S. has just begun easing COVID-19 restrictions after two years of pandemic policies such as masking and social distancing.

All U.S. states have dropped their mask mandates as the Centers for Disease Control and Prevention said most areas in the U.S. did not need to require masks indoors.

See the article here:

Fauci warns COVID-19 infection rates likely to increase - WGN TV Chicago

Last November, having alerted the world to the new and highly transmissible Omicron variant of the Sars-CoV-2 virus, South Africa-based scientist Tulio de Oliveira saw that country hit with travel bans.

Already smarting at what he saw as wealthier nations hoarding of vaccines, antiviral drugs and test reagents, his frustration spilled over. If the world keeps punishing Africa for the discovery of Omicron and global health scientists keep taking the data, who will share early data again? he tweeted.

Two years into this pandemic, as the World Health Organization (WHO) mulls the tricky question of when to call it over and some countries, including the UK, pre-empt that decision, the worlds attention is turning to the future.

How do we improve our response to the next pandemic?

There are two main challenges: improving the surveillance of pathogens; and ensuring vaccine equity.

And as De Oliveira intimated, these are linked. Not only morally, but for the first time in pandemic history, legally.

It used to be that living organisms, including pathogens, were considered humanitys common heritage, and sharing them for scientific purposes happened informally.

That changed with the UNs 1992 convention on biological diversity (CBD), which states that countries have sovereign rights over genetic resources found on their territory.

Under an annex to that convention, the Nagoya protocol, the host country can set terms for accessing those resources and for ensuring the fair and equitable sharing of benefits arising from them.

Covid-19 is the first pandemic since Nagoya entered into force in 2014, but the spirit of the protocol has not been respected. Starting with China in January 2020, countries have shared Sars-CoV-2-related data freely, demanding nothing in return.

That data has driven revolutions in vaccinology, pathogen sequencing and data collection. But the fruits of those revolutions have not been shared equitably.

Just 14% of people in low-income countries have received at least one vaccine dose, compared with about 80% in high- and upper middle-income countries.

The WHO is now proposing several separate initiatives to improve surveillance, including two Europe-based hubs for the international sharing of pathogen data and samples. But these proposals, too, effectively ignore Nagoya.

The WHO expects countries to contribute to the hubs for the common good, possibly even on pain of sanctions. Though it has been vocal about the need for vaccine equity, none of the current proposals explicitly address benefit-sharing.

Were treating pathogen-sharing as a common good, but were not treating vaccines and medical countermeasures as a common good, sayslegal scholar Mark Eccleston-Turner of Kings College London.

Eccleston-Turner says human pathogens should be excluded from Nagoya and vaccines should be similarly reclassified.

Practically, he suggests, this might be enshrined in a pandemic treaty the WHO is working on, that could apportion intellectual property (IP) rights according to the ratio of public-private investment in vaccine development.

The three or four leading coronavirus vaccines all took a different route to market, but one thing they have in common, according to IP law specialist Luke McDonagh of the London School of Economics, is that the public bore most of the risk and the drug companies maintained most of the IP.

More of the IP should stay in the public domain, he says, reflecting taxpayers investment. McDonagh points to research showing private-sector claims that reducing their IP dominance would dilute innovation do not hold up, and gives the example of antiretroviral drugs for HIV the subject of an earlier IP battle.

The fact of generic production in the global south has not affected incentives for HIV research in the rich countries, he says.

But changing the status quo via a new treaty may not be easy without government backing, he admits, and the UK and EU are among those whose current stance on patents suggests they might oppose it. Sharing knowhow and building up vaccine manufacturing capacity globally are also vital for achieving vaccine equity, he says, and the WHO is promoting both.

There may be a radically different solution: leave pathogens in Nagoya and respect its insistence on equitable benefit-sharing.

There is a precedent, says Edward Hammond, a Texas-based consultant who has advised low- and middle-income countries on the implications of Nagoya. He points to a successful implementation of Nagoya in the WHOs own pandemic influenza preparedness (PIP) framework.

Through PIP, WHO member states share samples of flu viruses that have human pandemic potential, and the WHO receives a share of the benefits. It has generated over $250m [190m] in cash payments from vaccine [and other] companies, Hammond says.

Some have said applying Nagoya to pathogens would at best create delays in sharing and at worst give control to bad actors. In the event of another pandemic, some country might assert its rights over virus samples, keeping the rest of the world in the dark, Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, wrote in a blog post at Stat last November.

It is not just drug companies expressing that view. It is shared by some in public health. Three years ago, Vasee Moorthy, a senior science adviser at the WHO, worked on a study into the impact of Nagoya on public health. Certain people were worried that there might be delays, but we havent seen that, Moorthy says.

If anything, the study found that the protocol encourages pathogen-sharing by building trust that benefits will be fairly shared. As Moorthy says: Sharing is in everyones interests.

De Oliveira agrees. With its history of fighting HIV, he says, South Africa would never withhold crucial data whose rapid release it knows could potentially save millions of lives, but unfortunately not every country has this long-term experience or transparent government and they might withhold.

To avoid that, he says, containment measures including travel bans should be balanced by financial or other support.

Nagoya is not perfect, Hammond admits. For one thing, it only covers physical samples, not the digital sequence data that is increasingly all that is needed to make vaccines, tests and drugs though he and others are lobbying to change that.

But it does embrace the spirit of the era, with its accent on reciprocity. It allows for multilateral benefit sharing, as befits a pandemic. It could, he feels, have prevented or at least mitigated vaccine nationalism.

And PIP could provide the model for a better instrument that covers many pathogens, including the one that causes the next pandemic.

Continued here:

How should the world respond to the next pandemic? - The Guardian