Category Archives: Covid-19

The Madras High Court on Friday asked the Tamil Nadu government to submit by June 28 a preliminary report on the total number of deaths related to Covid-19 being reported in the state.

The Madras High Court sought the report while hearing a case in which it was alleged that many Covid-19 positive patients' deaths in hospitals were passed off as deaths due to lung or heart diseases and not Covid particularly. Concerns were raised over the matter as this has led to families of many victims not being able to avail monitory relief.

The high court said that across the country, there are several reports alleging that Covid-19 deaths are not being recorded properly in Tamil Nadu.

ALSO READ | Patna HC says jump in Bihar Covid-19 toll a serious concern; hearing today

The court observed that only accurate reporting will help in providing relief to the family of the deceased Covid-19 patients.

In its order, the court said, "As far as this state is concerned, there are reports in some quarters that unless a positive test report was issued in respect of the patient, the subsequent death would not be recorded as a Covid death. There are other issues pertaining to not attributing the death to Covid-19 in the event the patient suffered from other ailments."

The high court also said if a patient has suffered heart attack, then in this case, the underlying condition which might be Covid-19, also be mentioned as the cause of death.

The court said, "Without attempting to go into the specialised domain of doctors and persons trained in such regard, it is elementary that the major ailment suffered by a person may result ultimately in the heart being attacked and the death due to such attack. However, the cause of the death in such a case may not be appropriately attributed to just a heart-attack, but the underlying reason for the heart being attacked ought to be regarded as the real cause. So has it to be done in case of deaths triggered by Covid-19, even if the person suffered from co-morbidities."

The court said this will not only help the family of the deceased Covid-19 patient get monetary relief, but will also be a reference for future study on the pandemic.

"Apart from the fact that the accurate reporting or recording of deaths would help in studies being undertaken to deal with a pandemic of this nature in future, the immediate concern in some cases is that the relief that the family of a person who died due to Covid-19 is otherwise entitled to may not be available unless the death certificate attributes the cause of death to Covid-19," said the court.

The court also said that an appropriate study must be conducted by a specialised team, if necessary. The court further said that it would also be fit and proper to require death certificates already issued to be revised, if required.

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Madras HC asks Tamil Nadu govt to submit report on Covid ...

A Japanese company has started human trials of the first once-a-day pill for Covid-19 patients, joining Pfizer Inc. and Merck & Co. in the race to find treatments for the disease.

Osaka-based Shionogi & Co., which helped develop the blockbuster cholesterol drug Crestor, said it designed its pill to attack the Covid-19 virus. It said the once-a-day dosing would be more convenient. The company said it is testing the drug and any side effects in trials that began this month and are likely to continue until next year.

Shionogi is months behind Pfizer and Merck, which have started later-stage tests of pills to treat Covid-19. Pfizer has said its twice-daily pill could be ready to hit the market as soon as this year. It is preparing to enroll more than 2,000 patients in a test of the antiviral pill combined with a booster antiviral drug against a placebo.

All three companies aim to fill one of the biggest gaps in fighting the pandemic. Vaccines remain effective at preventing serious illness from known strains of the Covid-19 virus including the contagious Delta strain, studies have shown. But some people dont want to get vaccinated, and cases can occur for those who do get their shots.

Existing treatments, including Gilead Sciences Inc.s infused antiviral drug remdesivir, generally have to be administered in hospitals and work only some of the time. Other drugs that can be given in hospitals include monoclonal antibody drugs such as one made by Regeneron Pharmaceuticals Inc. and the steroid dexamethasone.

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Covid-19 Pill Race Heats Up as Japanese Firm Vies With Pfizer, Merck - WSJ - The Wall Street Journal

When Johnnett Kent learned she had lung cancer, the COVID-19 pandemic was already descending on California. Her doctor didnt want the 49-year-old to risk her health by heading into a crowded clinic between surgery, radiation and chemotherapy.

So she started checking in with Kent through her smartphone. Kent was skeptical of the arrangement at first, thinking, Can this really work?

Her Wi-Fi was glitchy and video calls froze as she tried to talk from her bed. Sometimes the internet was shut off entirely at her Burbank apartment because Kent had lost work and was short on money to pay bills.

But when the video froze, her doctor would make an audio call to go over her symptoms. Her oncologist monitored her vital signs from afar, providing Kent a device with a sensor that attaches to her body. At one point, she ended up getting a blood transfusion after her oncologist got concerned about the signs it detected.

It kind of saved my life, said Kent, a patient with Los Angeles Christian Health Centers and Beverly Hills Cancer Center. Had I not had this access to technology, I might not be here.

Now Kent is in remission and planning to rebuild her business as a private chef and caterer as the pandemic has eased its grip on daily life. And she still wants to hang on to telehealth as an option.

Telehealth, which went up dramatically in use during the COVID-19 pandemic, has long been envisioned as a way to help patients without forcing them to trek to a clinic. Reaching a doctor by computer or phone can be easier for patients who cant take time off work, need to juggle child care or have to take a string of buses to get to a medical office.

But the rise of telehealth has also raised concerns about perpetuating unequal access to care, partly due to the digital divide. Poorer residents remain much less likely than wealthy ones to have broadband internet access, according to the Pew Research Center. Rural areas are also at a disadvantage for broadband.

Video visits can gobble up limited data on phone plans and are especially hard for patients who dont have a private place to talk, including people living in crowded homes or on the streets. And downloading a new app or logging in to an online platform for medical visits can be daunting for patients who arent at ease with the technology.

In South Gate, Lourdes Bernis said her late mother, who had been diagnosed with Alzheimers and Parkinsons, seemed confused during video visits with her doctors. When one physician asked her to rate her pain on a scale of 1 to 10, she didnt understand what he meant, Bernis said.

She helped her mother set up the videoconferences, but the process seemed difficult for seniors living alone. They dont know how to use this technology, Bernis, who works as a health promotora with L.A. County, said in Spanish.

Johnnett Kent demonstrates how she attaches a sensor to her body at home in Burbank that her doctors can monitor remotely.

(Christina House/Los Angeles Times)

As telehealth boomed last year, eased by new flexibility in billing rules, we were worried about which of our patients we might be leaving behind, said Dr. Lauren Eberly, a fellow in cardiovascular medicine at the University of Pennsylvania.

Early in the pandemic, Eberly and other researchers found that people who are older or do not speak English were less likely to use either video or audio-only visits, along with patients of Asian descent. Video visits were a particular barrier for many groups and were used at lower rates by Black, Latinx and poorer patients, among others, their study found.

In addition, many people who were not fluent in English did not get telehealth in their preferred language, especially those who did not speak Spanish, according to research by the California Pan-Ethnic Health Network. Its surveys also found that Asian respondents were less likely to have a private place to keep a telehealth appointment and that Latinx respondents were most likely to report technological barriers such as a spotty internet connection.

Health providers are still grappling with those inequities: Telehealth use has fallen somewhat since the height of the pandemic, but many health providers say they cant imagine going back to a strictly face-to-face practice.

Besides video or phone appointments, telehealth can also include remote monitoring and store-and-forward technology to send images or medical data to a provider. A California Health Benefits Review Program analysis of existing studies found mixed evidence for how telehealth compares with seeing a doctor in person, depending on what medical condition, specific kind of outcome and method was being studied.

The pandemic has absolutely changed peoples view of what is possible, said Center for Care Innovations President Sofi Bergkvist, whose organization launched a program to help safety net health providers improve virtual care.

You can reach people, where they are, in a way that you couldnt before, Bergkvist said. However, it really requires concentrated efforts and it must not be at the expense of quality of care.

At White Memorial Community Health Center, a Boyle Heights center that serves patients who are largely insured through Medi-Cal, telehealth will remain an important option for older, disabled or otherwise vulnerable patients who struggle with transportation, said Chief Executive Grace Floutsis.

The challenge, she said, is that many of those same patients have trouble downloading and accessing a new app for telehealth visits. So the center made a simple change: It started texting them links to click on for appointments.

The San Fernando Community Health Center launched a pilot program during the pandemic to remotely monitor some of its diabetes patients, giving them iPads and equipment such as a blood pressure monitor to feed information about their health to doctors without visiting the clinic.

The center fielded a team to handle any technological problems, and if they dont read or write, everything in the program is color-coded, said Heidi Lennartz, its chief operating officer.

And L.A. Care, a publicly operated health plan, has been setting aside space in its community resource centers for private rooms for telehealth visits, a new addition for sites that offer classes on parenting and healthy cooking, Zumba and yoga, and giveaways of groceries and school supplies.

At a new center near Western Avenue and Pico Boulevard, community representative Haidy Juarez showed off a pair of small rooms each equipped with a laptop, headphones and a printer. Their goal is to provide people the privacy and technology that might make a telehealth appointment impossible at home.

Both rooms were sitting empty on a recent Monday: L.A. Care is still trying to get the word out to people about the option as they trickle back into the centers, said Mabel Ponce, a senior manager of its community resource centers.

When the pandemic hit, clinics had to find out from their patients: Did they have computers? Did they have a webcam? Did they have a phone? said Margarita Loeza, chief medical information officer for Venice Family Clinic. Some patients also needed equipment like a blood pressure monitor or a glucometer for telehealth visits.

We started seeing how hard it was for people who didnt have everything, Loeza said.

At Venice Family Clinic, the bulk of telehealth visits are happening by phone rather than video, according to its staff.

Phone visits appear to have been crucial for poorer patients: As COVID-19 swept through California, federally qualified health centers that target underserved groups did the bulk of their telehealth visits by phone rather than video, according to research published in the Journal of the American Medical Assn.

Cruz Cubias, an 80-year-old diabetes patient living in South Park, was relieved to not to have to make the trip to a downtown clinic run by Eisner Health for routine visits during the pandemic. She relied on audio calls for her telehealth appointments. Cubias said her granddaughter has a phone that can make video calls, but she needs it to study.

One hiccup, Cubias said, was that she didnt have a way to take her own blood pressure at home. But the doctor understood what I was saying and I understood him, said Cubias, who speaks Spanish.

Eberly said her study found that although Black and Latinx patients were less likely than white patients to use video visits, they were more likely to use telehealth in general, with the majority using phone calls. At Umma Community Clinic, Yohanna Barth-Rogers said no-show rates dropped with the rise of telehealth at the clinics centers.

People would often take the call from work, and theyd step away for 15 minutes to talk to their doctor, Barth-Rogers said. Phone visits might not always be ideal, she said, but if thats the only way theyre going to be seen, some access is better than no access.

During the pandemic, California paved the way for telehealth for poorer patients by insisting that Medi-Cal reimburse providers at the same rate for audio and video visits as for in-person clinic visits. Before that, many clinics that serve low-income patients were unable to get reimbursed for telehealth visits.

The California Primary Care Foundation and other groups have pushed to keep the policy as coronavirus cases have receded, arguing that phone visits must be included.

Warren Brodine, CEO of the Eisner Health/Pediatric and Family Medical Foundation, argued that phone calls can sometimes be better than a video call that could be overheard for instance, discreetly checking with a patient whether they are safe at home and can give patients more privacy. During the pandemic, we had patients who were ducking in closets, who were going out behind the carport, trying to find anywhere that they could go, Brodine said.

Keith T. Kanel, director of the Division of Practice Improvement at the Agency for Healthcare Research and Quality, said that paying doctors for phone visits has been the most contentious aspect of the telehealth debate as the pandemic ebbs. When COVID-19 hit, audio calls were a reliable technology, and it was the one that was egalitarian, Kanel said.

But there have been questions about the adequacy of phone visits: One recently published study found that rural patients in Canada were more satisfied with video than phone calls.

The California Health Benefits Review Program found evidence that phone visits seem to measure up to in-person care on physiological measures of how patients fare, but it was inconclusive on other measures, such as how often they went to the emergency room. Research on phone visits is thinner than on video visits.

Fraud has also been a concern among regulators. And the California Chamber of Commerce recently warned lawmakers that without clearer guidelines about reimbursing doctors for phone visits, even the simplest and shortest patient-provider telephone interactions could be reimbursed at the same level as face-to-face care, ramping up premiums.

State leaders decided both audio and video visits would be fully reimbursed through 2022, but the payment structure beyond that remains to be determined. Bergkvist said such uncertainty has held back some clinics from spending time or money improving telehealth.

As long as theres uncertainty, I think theres many leaders that are sitting on the fence, she said.

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Telehealth leapt forward with COVID-19. Who was left behind? - Los Angeles Times

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Of the 8,787 people who have died in Texas due to COVID-19 since early February, at least 43 were fully vaccinated, the Texas Department of State Health Services said.

That means 99.5% of people who died due to COVID-19 in Texas from Feb. 8 to July 14 were unvaccinated, while 0.5% were the result of breakthrough infections, which DSHS defines as people who contracted the virus two weeks after being fully vaccinated.

All people 12 and older are eligible for the COVID-19 vaccine in Texas. Children ages 12-17 can get the Pfizer vaccine, but COVID-19 vaccines are not mandatory for Texas students.

State and local health officials say that vaccine supply is healthy enough to meet demand across much of Texas. Most chain pharmacies and many independent ones have a ready supply of the vaccine, which is administered free and mainly on a walk-in basis. Many private doctors' offices also have it. And you can check current lists of large vaccine hubs that are still operating here.Public health departments also have vaccines. You can register with the Texas Public Health Vaccine Scheduler either And businesses or civic organizations can set up their vaccine clinics to offer it to employers, visitors, customers or members.

Yes. Medical experts recommend that people who have had COVID-19 should still get the vaccine. If someones treatment included monoclonal antibodies or convalescent plasma, they should talk to their doctor before scheduling a vaccine appointment. The CDC recommends that people who received those treatments should wait 90 days before getting the vaccine.

Yes. Health experts and public officials widely agree that the vaccine is safe. The three currently approved vaccine manufacturers Pfizer, Moderna and Johnson & Johnson reported their vaccines are 95%, 94% and 72% effective, respectively, at protecting people from serious illness. While no vaccine is without side effects, clinical trials for Pfizer, Moderna and Johnson & Johnson show serious reactions are rare.

The agency said nearly 75% of the 43 vaccinated people who died were fighting a serious underlying condition, such as diabetes, heart disease, high blood pressure, cancer or chronic lung disease.

Additionally, it said 95% of the 43 vaccinated people who died were 60 or older, and that a majority of them were white and a majority were men.

DSHS noted that these are preliminary numbers, which could change because each case must be confirmed through public health investigations. Statewide, more than 50,000 people have died of COVID-19 since March 2020, but the rate of deaths has slowed dramatically since vaccines became widely available in April.

Dr. David Lakey, the chief medical officer of the University of Texas System, said people succumbing to the coronavirus despite being vaccinated was not unexpected.

No vaccine is 100%, said Lakey, who is also a member of the Texas Medical Associations COVID-19 task force. And weve known for a long while that the vaccines arent 100%, but theyre really really good at preventing severe disease and hospitalizations. There will always be some individuals that will succumb to the illness in the absence of full herd immunity.

He added that 0.5% is a very low number of individuals in a state of 30 million. In the grand perspective of everything, thats not a large number that would call into question at all the use of this vaccine.

COVID-19 cases have been surging in Texas and nationally mostly among unvaccinated people as the highly contagious delta variant has become dominant. The Pfizer-BioNTech vaccine is 88% effective against symptomatic cases of the delta variant and 96% effective against hospitalizations, according to Yale Medicine. Researchers are still studying the efficacy of the Moderna vaccine against the delta variant but believe it may work similarly to Pfizer.

As of Monday, 42.8% of Texans have been fully vaccinated; the state continues to lag behind the national vaccination rate of 48.8%, according to the Mayo Clinic.

DSHS doesnt track the number of COVID-19 hospitalizations among vaccinated people statewide because hospitals are not required to report that information to the state. Travis Countys health authority, Dr. Desmar Walkes, told county commissioners and Austin City Council members in a Tuesday meeting that almost all new COVID-19 cases and hospitalizations in the area have been among unvaccinated people.

Its not surprising that we have [increasing COVID-19] cases, Lakey said. This delta variant spreads very rapidly among individuals, and theres only some of these individuals who have been vaccinated, and a small number of those will have severe disease. But the vast majority of the people that have severe disease will be the unvaccinated individuals.

To count deaths from the virus statewide, DSHS analyzes death certificates to find people whose cause of death was listed as COVID-19. Those records are then checked against immunization records to see if each person was vaccinated.

Disclosure: The Texas Medical Association and the University of Texas System have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Texas has seen nearly 9000 COVID-19 deaths since February. All but 43 were unvaccinated people. - The Texas Tribune

After weeks at some of the lowest levels of COVID-19 since last year, the number of COVID-19 cases and the size of outbreaks in King County have begun to rise again. An uptick is not unexpected as restrictions on activities are relaxed, but the rising numbers should prompt all of us vaccinated as well as unvaccinated to take extra precautions.

COVID-19 has been on the rise in King County since June 29, when King Countys indoor mask Directive ended. At that time, Public Health was reporting an average of 61 new cases daily. Since then, our average daily case counts have swelled to 141 a 130% increase in just over three weeks.

Hospitalizations and deaths have remained relatively low compared to past peaks, which is what we would expect in a county with relatively high rates of vaccine coverage. But recently, hospitalizations are also on the rise. Over the last seven days, 45 people were admitted to the hospital in King County for COVID-19, a 32% increase over the previous week, and the hospitalization rate has doubled from 1 per 100,000 per week on July 7 to 2 per 100,000 per week on July 17.

A number of recent outbreaks have occurred in indoor settings where people have prolonged contact with one another, such as gyms and social gatherings.These outbreaks, like others reported nationally, include indoor public settings where unvaccinated and fully vaccinated people are in contact with each other and are not masking. There are some instances of infection even among vaccinated people engaging in indoor activity in a poorly ventilated space without masks.

The best way to stem this increase is for everyone who is eligible to get vaccinated. The large majority of recent cases, hospitalizations and deaths are among unvaccinated residents. Over the past 30 days in King County, 94% of hospitalizations and 94% of deaths due to COVID-19 occurred among people who arent fully vaccinated.

While the share of COVID-19 cases among fully vaccinated people has increased over the last month, illness rates among vaccinated people are low compared with unvaccinated people. About 14% of people who tested positive for COVID-19 between June 9 July 6 were fully vaccinated, compared with 86% who were not. The hospitalization rate is 34 times higher among unvaccinated residents compared to vaccinated residents, and the death rate due to COVID-19 is 43 times higher among unvaccinated residents compared to vaccinated residents.

COVID-19 vaccines provide very high-level protection against whats most important: serious infections with hospitalization and deaths. Since no vaccine is 100% effective, its not surprising that some vaccinated people may develop COVID-19 and be able to pass the infection to others, although that is much less likely than for unvaccinated people.When vaccinated people do become infected, their illness is typically mild and not serious.Unfortunately, the Delta variant may increase the risk of vaccinated people developing mild breakthrough infections compared to earlier strains, but our vaccines still offer excellent protection.

When youre exposed to COVID-19 today in King County, its most likely that youre being exposed to a highly contagious variant of the virus. Of the recent COVID-19 test samples genetically sequenced in King County, about 90% represent a variant of concern and not the original strain of the virus, and about 60% of these are the Delta variant. This is concerning because the Delta variant is so contagious.

Nailing down exactly where people are being exposed is complicated. Contact tracers ask people who test positive for COVID-19 about where theyve spent time during their contagious period. Comparing the most recent 30 days with the month prior, an increasing share of people with COVID-19 report having attended a social event (36% vs 28%), visited a bar or restaurant (15% vs 10%), or and to have travelled out-of-state (17% vs 9%).

This virus will is getting better and better at finding people who are unvaccinated, and that is what we are seeing in the recent data from King County, said Dr. Jeff Duchin, Health Officer, Public Health Seattle & King County. While we would all like to have COVID-19 completely in the rearview mirror, and although our vaccines are greatly diminishing the threat, we remain vulnerable to continuing COVID-19 spread impacting our community, especially for those who remain unvaccinated and those who arent able to be protected, including children under 12 and people who are immunocompromised.

The most important way to protect yourself and your community is to get vaccinated. Vaccines provide strong protection against the original strain of COVID-19 and variants of concern.

The increasing numbers mean that all of us, even people who are fully vaccinated, should consider taking extra precautions, especially in indoor settings with other people. Unvaccinated people are currently required to continue wearing masks in public, indoor spaces and should continue to do so.

Public Health Seattle & King County now recommends that all residents five years of age and older, regardless of vaccination status, wear face coverings in indoor public settings. This extra layer of protection will help us all stay safer, including those who are unvaccinated, such as the 300,000 children in King County who arent able to get vaccinated yet, and the many thousands of people who have immune systems that are weakened or suppressed.

Washington State already requires unvaccinated people to wear masks in indoor public settings, although in stores and other public spaces, there is no practical way to know who is vaccinated and who isnt. For this reason, universal masking in indoor public spaces provides a more reliable way to ensure everyone is safer as we monitor the current increasing disease trends.

Masking in public spaces is also beneficial for those who are in close contact with someone at increased risk, to model mask-wearing for children, and to protect from other respiratory illnesses or allergens.

Originally published July 23, 2021

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COVID-19 cases increasing in King County: Vaccination continues to be our best protection - Public Health Insider

Over the last decade, Dr. Mercola has built a vast operation to push natural health cures, disseminate anti-vaccination content and profit from all of it, said researchers who have studied his network. In 2017, he filed an affidavit claiming his net worth was in excess of $100 million.

And rather than directly stating online that vaccines dont work, Dr. Mercolas posts often ask pointed questions about their safety and discuss studies that other doctors have refuted. Facebook and Twitter have allowed some of his posts to remain up with caution labels, and the companies have struggled to create rules to pull down posts that have nuance.

He has been given new life by social media, which he exploits skillfully and ruthlessly to bring people into his thrall, said Imran Ahmed, director of the Center for Countering Digital Hate, which studies misinformation and hate speech. Its Disinformation Dozen report has been cited in congressional hearings and by the White House.

In an email, Dr. Mercola said it was quite peculiar to me that I am named as the #1 superspreader of misinformation. Some of his Facebook posts were only liked by hundreds of people, he said, so he didnt understand how the relatively small number of shares could possibly cause such calamity to Bidens multibillion dollar vaccination campaign.

The efforts against him are political, Dr. Mercola added, and he accused the White House of illegal censorship by colluding with social media companies.

He did not address whether his coronavirus claims were factual. I am the lead author of a peer reviewed publication regarding vitamin D and the risk of Covid-19 and I have every right to inform the public by sharing my medical research, he said. He did not identify the publication, and The Times was unable to verify his claim.

July 24, 2021, 11:34 a.m. ET

A native of Chicago, Dr. Mercola started a small private practice in 1985 in Schaumburg, Ill. In the 1990s, he began shifting to natural health medicine and opened his main website, Mercola.com, to share his treatments, cures and advice. The site urges people to take control of your health.

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The Most Influential Spreader of Coronavirus Misinformation Online - The New York Times

Associated Press| Associated Press

CORUNNA, Mich. Elected officials in a conservative Michigan county who gave themselves bonuses of $65,000 with federal COVID-19 relief aid said they will return the money following days of criticism.

Shiawassee County commissioners acted after the prosecutor said the payments were illegal, The Argus-Press reported.

The Michigan Constitution bars additional compensation for elected officials after services had already been rendered, prosecutor Scott Koerner said Friday.

The commissioners, all Republicans, voted on July 15 to award themselves $65,000 as part of a plan to give $557,000 to 250 county employees as hazard pay for dealing with the coronavirus pandemic.

The smallest amounts for recipients were $1,000 to $2,000. But County Board Chairman Jeremy Root got $25,000. Two more commissioners received $10,000 each, while four others received $5,000 each.

The vote was 6-0 with one commissioner absent.

The commissioners awarded money to other elected officials, including the prosecutor, the sheriff and the county clerk, all Republicans. They, too, said they would give it back.

Since these payments were made, confusion about the nature of these funds has run rampant, a statement from commissioners said. (We) deeply regret that this gesture has been misinterpreted, and have unanimously decided to voluntarily return the funds to the county, pending additional guidance from the state of Michigan.

Commissioner Marlene Webster insisted she had no idea that she had voted to pay herself and returned the money last week, even posting a copy of the check on Facebook. She criticized the latest statement, saying there was no misinterpretation of the payments.

Thats an insult to the citizens of Shiawassee County, Webster said.

Two Michigan congressmen, a Democrat and a Republican, said federal virus aid wasnt intended to reward elected officials.

Separately, a judge set a hearing for Monday in a lawsuit aimed at rescinding bonuses for the officials. It was filed before the latest action.

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Shiawassee County officials will return COVID-19 relief aid bonuses they gave themselves - Detroit Free Press

The Biden administration now believes that fully vaccinated people who are older or immunocompromised may need a booster shot.

Though all three vaccines authorized for use in the United States Pfizer/BioNTech, Moderna, and Johnson & Johnson are highly effective in preventing Covid-19 infections, recent data suggests that the efficacy of Pfizers two-dose vaccine can wane slightly four to six months after vaccination, according to the New York Times.

However, a booster shot could lift antibody levels even more substantially than the current two-dose regimen for the Pfizer and Moderna vaccines, and could be especially beneficial for people 65 and older and those who are immunocompromised.

People who are immunocompromised may receive significantly less immune protection than the general population after two vaccine doses, increasing the upside of a potential third shot.

According to a Centers for Disease Control and Prevention advisory committee, which met earlier this week to discuss the potential need for booster shots, about 2.7 percent of the US population is currently immunocompromised in some way, whether due to ongoing medical treatment like chemotherapy, their status as organ transplant recipients, or another reason.

Immunocompromised people are also more likely to become severely ill from Covid-19, and they have a markedly higher chance of experiencing breakthrough infections despite being vaccinated a concern magnified by a delta variant-fueled resurgence of Covid-19 cases in the US.

As things stand, data from Pfizer indicates that its vaccine the first to be authorized in the US, and still the most common among US vaccine recipients declines from 95 percent to 84 percent effectiveness against symptomatic infection after four to six months, according to the Times Sharon LaFraniere.

Data from Israel, where Covid cases are once again rising, suggest that an even sharper decline in effectiveness against symptomatic infections is possible but even then, the vaccine remains more than 90 percent effective in preventing severe disease, and the small sample size means there is still uncertainty about Israels findings.

The goal of this vaccine is not to prevent mild or low, moderate infectious disease, Dr. Paul Offit, a member of the Food and Drug Administrations outside advisory committee, told the Times. The goal is to prevent hospitalization to death. Right now this vaccine has held up to that.

A booster shot administered at the six-month mark could increase antibody levels as much as tenfold, according to data released earlier this year by both Pfizer and Moderna, underscoring its potential value to older and immunocompromised people.

Israel is already offering a third Pfizer shot for immunocompromised residents though millions of Palestinians in the West Bank and the Gaza Strip have yet to be vaccinated and Pfizer has previously suggested that a booster shot could be needed in the US.

Though the US currently has tens of millions of surplus Covid-19 vaccine doses on hand, making a third Pfizer or Moderna shot available to millions of immunocompromised or elderly Americans likely wont be a quick process.

Currently, all three Covid-19 vaccines in use in the US are being administered under an emergency use authorization, or EUA, issued by the FDA, which sets specific regimens for each vaccine: two doses several weeks apart for both Pfizer and Moderna, and a single dose for Johnson & Johnson.

Changing that, according to the Washington Post, would require either full FDA approval for the vaccine or an amendment to the EUA. And until that happens, the CDCs Advisory Committee on Immunization Practices cant go forward with recommending a third shot for vulnerable populations in the US.

According to the New York Times, doctors would have vastly more leeway to prescribe a booster for their patients once the vaccine is fully approved by the FDA.

However, there are some potential workarounds to get third shots in arms more quickly. According to Dr. Amanda Cohn, chief medical officer for the CDCs immunization and respiratory diseases center, the US is actively looking into ways ... to potentially provide access earlier than any potential change in regulatory decisions including through a study, or through an investigational new drug format.

As the Washington Post reported after the advisory board meeting earlier this week, that strategy could open up access to a third shot under the FDAs compassionate use program, which would require enrolling individuals in a clinical study where additional doses can be given.

President Joe Biden also struck an encouraging tone on the prospects for the FDAs full vaccine approval in coming months, at a recent town hall in Cincinnati, Ohio.

Theyre [the FDA] not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, theyll get a final approval, Biden told CNNs Don Lemon on Wednesday.

Full FDA approval requires a massive amount of data, including at least six months of vaccine efficacy data, and it usually takes about 10 months for the agency to review license applications and reach a decision.

When we were reviewing applications back when they were on paper, there was so much, it would not fit on the freight elevator, Norman Baylor, the former head of the FDAs Office of Vaccines Research and Review, told CNN. Thats how big the application is.

However, the Pfizer/BioNTech vaccine has already been granted a priority review, which shortens the potential timeline to six months, and multiple officials have said approval will likely come even sooner, potentially clearing the way for booster shots for older and immunocompromised people.

Moderna is currently in the process of completing our rolling submission to the FDA, according to a Moderna spokesperson, and approval for the Moderna vaccine will almost certainly take longer. The company told CNN this week that it has no specific timeline in place yet.

Full FDA approval could also have a number of other benefits, in addition to opening up the possibility of booster shots for vulnerable groups. As NBCs Shannon Pettypiece explained on Tuesday, the official regulatory signoff would remove a significant legal and public relations barrier for businesses and government agencies that want to require vaccinations for their employees and customers, and could also boost vaccine confidence.

Thus far, the US has largely held back from imposing vaccine mandates, though other countries, such as France, have embraced them to positive effect.

As the Biden administration consensus coalesces behind the need for a booster shot for vulnerable groups, the delta variant of Covid-19 is gaining ground quickly in the US, fueling a sharp rise in new cases.

On Saturday, the US reported a rolling seven-day average of nearly 50,000 cases per day the highest level since early May, according to CNNs Ryan Struyk, and almost 39,000 more cases than the same seven-day average in late June.

Additionally, at a Thursday White House briefing on the pandemic, CDC director Dr. Rochelle Walensky warned that the delta variant now represents more than 83 percent of the virus circulating in the United States.

Compared to the virus we had circulating initially in the United States at the start of the pandemic, the delta variant is more aggressive and much more transmissible than previously circulating strains, Walensky said. It is one of the most infectious respiratory viruses we know of and that I have seen in my 20-year career.

As Voxs Umair Irfan explained in late June, when delta accounted for just 20 percent of new Covid cases in the US, the CDC has identified delta as one of five variants of concern. Not only does it spread far faster than the original strain of Covid, but its better at evading vaccine protections, and, as Irfan reports, theres some evidence that it can cause more severe outcomes from Covid-19 compared to the original versions of the virus.

Despite those breakthrough cases, however, the delta surge is overwhelmingly proving to be a pandemic of the unvaccinated, as Walensky put it earlier this month. In the US, more than 99 percent of recent deaths and about 97 percent of recent hospitalizations from Covid-19 have been among unvaccinated individuals.

As a result, this latest virus outbreak has been especially bad in parts of the US with low vaccine uptake, such as rural Missouri.

As The Atlantics Ed Yong reported from Missouri earlier this month, ICUs are also filling with younger patients, in their 20s, 30s, and 40s, including many with no underlying health problems.

According to Yong,

Almost every COVID-19 patient in Springfields hospitals is unvaccinated, and the dozen or so exceptions are all either elderly or immunocompromised people. The vaccines are working as intended, but the number of people who have refused to get their shots is crushing morale. Vaccines were meant to be the end of the pandemic. If people dont get them, the actual end will look more like Springfields present: a succession of COVID-19 waves that will break unevenly across the country until everyone has either been vaccinated or infected.

A swath of southern states, including Louisiana and Florida, are currently reporting more cases per 100,000 people than anywhere else in the US, with Florida alone contributing more than one-fifth of all new cases in the US.

Folks [are] supposed to have common sense, Alabama Gov. Kay Ivey, a Republican, said this week. But its time to start blaming the unvaccinated folks, not the regular folks. Its the unvaccinated folks that are letting us down.

Currently, only 34 percent of Alabamans are fully vaccinated the worst vaccination rate of the any state in the US, along with Mississippi.

As of Saturday, about 57 percent of the vaccine-eligible population in the US more than 162 million people have been fully vaccinated, according to data from the CDC. Another 15 million or so more have received at least one dose of the vaccine.

That level of widespread vaccination is unequivocally good news, but with US Covid cases on the rise and the delta variant running rampant, it invariably also means some of the new Covid cases in the US are breakthrough infections fully vaccinated people nonetheless testing positive for Covid-19.

As Voxs Umair Irfan explains,

The CDC definition of a breakthrough infection is a laboratory-confirmed infection more than 14 days after the final dose of a Covid-19 vaccine, as it can take a while for the full protection of a vaccine to spool up. This definition includes everything from infections that produce no symptoms at all to cases that result in death. People often think about infection and disease as being the same thing, and that is not the case, said Brianne Barker, a virologist at Drew University.

Its only when a virus starts causing symptoms that an infected person is said to have disease, so not all SARS-CoV-2 infections cause Covid-19. But as weve seen throughout the pandemic, people can carry and transmit the virus without falling ill themselves, creating a major route for the spread of Covid-19. Thats why tracking breakthrough cases is so important.

The good news about breakthrough infections, though, is that if youre vaccinated and get sick with Covid-19, youre far less likely to get severely ill than you would without a vaccine. With a vaccine, the chance of hospitalization and death are both reduced compared to unvaccinated individuals, according to Dr. Anthony Fauci, the United States top infectious disease expert.

If you look at the number of deaths, about 99.2 percent of them are unvaccinated. About 0.8 percent are vaccinated, Fauci told NBCs Chuck Todd on Meet the Press earlier this month. No vaccine is perfect. But when you talk about the avoidability of hospitalization and death ... its really sad and tragic that most all of these are avoidable and preventable.

Currently, the country is administering about 537,000 doses per day on average, down from more than a million per day on average at the start of July and that dropoff could fuel a brutal, self-reinforcing cycle.

Specifically, according to Irfan, with vaccination rates slowing, reports of people becoming infected after their immunizations could feed vaccine hesitancy, which in turn can fuel more breakthrough cases.

In reality, however, getting vaccinated actually heads off the risk of further breakthrough infections by making it harder for the virus to spread. And by the same token, getting more people vaccinated will also go a long way toward protecting older and immunocompromised people who have already been vaccinated but may now need a booster shot.

Each day, hundreds of thousands of Americans are choosing to protect themselves, their kids, and their neighbors by getting their first shot, White House Covid czar Jeff Zients said this week. These Americans are stepping up and doing their part. Each shot matters. Each additional person fully vaccinated is a step closer to putting this pandemic behind us.

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As the pandemic wears on, some Americans could need Covid-19 booster shots - Vox.com

Coronavirus cases rising

Justin Matthews reports.

TAMPA, Fla. - The COVID-19 pandemic is raging on across the country as the highly contagious delta variant infects unvaccinated and fully vaccinated people.

The average amount of new cases more than doubled nationwide in the past month. There were 11,500 new cases reported on June 20. This week, 38,000 new cases were reported, according to data from the Centers for Disease Control and Prevention.

"The really sad this is if we maintained the vaccination rates that we were seeing in April this all would've been done, we would've reached herd immunity by the third week in June and this would never have happened," said Dr. Thomas Unnasch, an infectious disease researcher at the University of South Florida who has been forecasting COVID-19 trends since the beginning of the pandemic. "The last three weeks have been the worst that I've seen since I started doing the calculations last summer."

In the last two weekly reports from the Florida Department of Health, the number of new infections increased from 23,000 to 45,000 to 73,000. Thats an average of more than 10,000 new cases per day.

READ States dial back coronavirus reporting just as COVID-19 cases surge

"We're about halfway up of what's going to be a really steep wave in infections which is being driven primarily by infections in the unvaccinated people," said Dr. Unnasch.

He says fully vaccinated people who are being infected barely have symptoms, like sniffles for a couple of days for example.

READ Floridas COVID-19 hospitalization rate increased 65% since last week

Unvaccinated people are having severe infections and thats why hospitals are filling back up, medical experts say.

Dr. Unnasch says the virus is eventually going to burn out because more people are being infected or being vaccinated. He anticipates the U.S. achieving herd immunity by September.

COVID UPDATES: Download the free FOX 13 News app for ongoing coronavirus coverage and live updates

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Fourth wave of COVID-19 pandemic is around the corner, health experts say - FOX 13 Tampa Bay

A Pfizer COVID-19 vaccine is administered at a mobile clinic in Los Angeles county, which has pockets of vaccine hesitancy.

By Rachel FrittsJul. 21, 2021 , 11:00 AM

In many U.S. regions, the Delta variant of SARS-CoV-2 has caused the COVID-19 pandemic to surge once again. Last weeks 7-day average of daily new cases increased by nearly 70%, to more than 26,000; hospitalizations have jumped by more than one-third, according to the Centers for Disease Control and Prevention.

Part of the reason is that less than half of the U.S. population is fully vaccinated. Some scientists and physicians worry vaccine hesitancy is fueled by the fact that shots available in the United Statesmade by Pfizer and BioNTech, Moderna, and Johnson & Johnson (J&J)have been authorized on an emergency basis but have yet to be fully approved. Antivaccine activists, talk show hosts, and far-right politicians have made the vaccines experimental nature a talking point.

Full approval from the Food and Drug Administration (FDA) could help win over skeptics, says Monica Gandhi, an infectious disease physician at the University of California, San Francisco. It means something to people for it to be approved, she says. It just seems like the simplest, easiest thing we could be doing right now.

Pfizer and Moderna have both applied for full FDA approval for their jabs, but it could be months away. Heres where things stand.

All three vaccines have been given an emergency use authorization (EUA), which FDA offers during crises as a quick way to give people access to potentially lifesaving medicines. In the past, EUAs have typically been used for drugs during very catastrophic, immediate circumstances, like an anthrax attack, says Jesse Goodman, a former chief scientist at FDA whos now at Georgetown University. The COVID-19 pandemic marks the first time EUAs have been granted for new vaccines.

To receive an EUA, vaccine manufacturers had to follow a special set of guidelines that asked for safety and efficacy data from clinical trials involving tens of thousands of participants, as well as information on vaccines quality and consistency. Pfizer and Moderna both received an EUA in December 2020; J&Js came in February. Based on the real-world data they have collected since then, Pfizer applied to FDA for full approval in early May, and Moderna on 1 June. J&J is expected to follow soon.

Its one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. Its not a huge difference, but it is a real difference, Goodman says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. Its an exhaustive review, Goodman says.

FDA is already familiar with much of the data, however, for instance on the very rare side effects caused by the J&J and Pfizer vaccines that didnt show up in clinical trials.

On 16 July, FDA accepted Pfizers application under priority reviewmeaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. The review has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date, an FDA press officer confirmed to Science in a statement.

FDA has not formally accepted Modernas application, possibly because the company has not yet submitted all the required materials.

Full approval could help overcome vaccine hesitancy, Eric Topol, director of the Scripps Research Translational Institute, wrote in a recent op-ed in The New York Times. Some people who understand that the E in EUA stands for emergency are waiting for full FDA approval before they receive a shot, he wrote.

I think its fair to say that any number of us who are clinical infectious disease doctors and in public health are frankly a little surprised at how long the process is taking, says William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center.

I want [FDA] to be careful. I also want them to move it along, Schaffner says. Frankly, Id like them to work on the weekends. The people who are vaccinating are working on the weekends. The virus is working on the weekends.

About 30% of unvaccinated people say they were waiting for vaccines to receive full approval, according to a survey of 1888 adults conducted in June by the Kaiser Family Foundation. But the report cautions that for many people, FDA approval is likely a proxy for general safety concerns. Not everyone now focused on approval may actually get a vaccine, especially if they perceive the approval process as rushed or politically motivated.

For the people who are really dead set against getting the vaccine at this point, I dont know that the FDA giving it full approval is going to make a huge difference, says Krutika Kuppalli, an infectious disease doctor at the Medical University of South Carolina who says many of her patients are wary of COVID-19 shots.

But full approval may sway some people. For example, for members of groups that have been treated poorly by the health care system, signing a consent form to get vaccinateda requirement for vaccines with an EUAmay be a psychological barrier, Gandhi says: Signing a consent that says experimental and the phrase experimental brings up issues of experimentation on Black and brown communities.

More than 500 U.S. universities and some high-profile hospitals have already issued vaccine mandates, meaning staff and students must be vaccinated.

But many schools and hospitals are hesitant to ask their employees to take what is technically still an experimental product and are holding out for full approval; so is the U.S. military. Some states, including those with some of the lowest vaccination rates in the country, such as Alabama, Arkansas, and Tennessee, have gone so far as to ban mandates in schools and colleges until vaccines are fully approved. (Conversely, a judge this week upheld Indiana Universitys vaccine mandate after it was challenged by a group of eight students.) Once a vaccine is approved, I think it will be on firmer foundation for organizations and businesses to mandate it, Goodman says.

In Francewhere vaccine hesitancy is also running highmore than 1 million people signed up for a vaccine after President Emmanuel Macron announced on 12 July that vaccination would become mandatory for health care workers and health passes would be required to enter malls, bars, restaurants, and other public places. But those measures proved controversial as well: Tens of thousands took to French streets on Saturday in protest.

Perhaps, but the agency does not want to rush. Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy, FDAs Peter Marks wrote in The New York Times in response to Topols plea for speed.

Any claims that this is taking a long time [are] almost like saying you dont want FDA to do the normal, complete job that it does, Goodman says. Regulatory rigor is especially important for messenger RNA vaccines, which use an entirely new technology, he adds.

Every expert Science talked to had the same message: The data amassed so far show the vaccines given an EUA in the United States are very safe and very effective. It was really incredible to see how well these vaccines worked in the clinical trials, Gandhi says.

The vaccines are such a gift, says Cody Meissner, a pediatrician at Tufts Childrens Hospital specializing in infectious diseases and a member of FDAs vaccine advisory committee. Every adult should get this vaccine.

*Correction, 22 July, 3:20 p.m.:This story has been corrected to show that Monica Gandhi is at the University of California, San Francisco, not the University of California, San Diego.

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When will COVID-19 vaccines be fully approvedand does it matter whether they are? - Science Magazine