US FDA advisory committee to determine if COVID-19 vaccine boosters are widely needed now
Union urges NFL to adopt daily COVID-19 testing for vaccinated players
There’s a decent chance that the COVID-19 pandemic will play more of a role during the 2021 NFL season than last year. We’re seeing relaxed protocols from the league as it relates to fully vaccinated players with Week 1 of the campaign slated to get going Thursday evening. It has already led to some COVID-related issues for teams. That includes star guard Zack Martin and the Dallas Cowboys with their opener against the Tampa Bay Buccaneers mere days away. Despite being fully vaccinated, Martin tested positive for the virus and will miss the game.NFLPA president JC Tretter of the Cleveland Browns touched on this recently.
A federal advisory committee will decide Friday whether third shots of COVID-19 vaccines are safe and protective against infections.
At root is whether the extra shots are "luxuries" or an essential part of providing complete protection against the virus, presidential adviser Dr. Anthony Fauci said this week.
He and other federal officials, including President Joe Biden, believe it is time to begin offering third shots to compensate for what appears to be fading protection. The government has agreements to purchase the doses and provide them at no cost to consumers.
Some states may soon need to ration care; US says it can give boosters while still sharing shots abroad: Live COVID-19 updates
Kentucky Gov. Andy Beshear said the state is "right at" or "quickly approaching" needing to ration care in hospitals due to COVID-19. Updates:For the first time, Idaho has authorized its hospitals to ration care, quietly enacting the "crisis standard of care" move Monday and publicly announcing it in a statement Tuesday — warning residents that they may not get the care they would normally expect if they're hospitalized.
Others, particularly the director general of the World Health Organization, argue that Americans would benefit far more by getting initial shots to the unvaccinated around the world.
The Food and Drug Administration advisory committee will consider information from Pfizer and its German partner BioNTech in deciding whether to allow the companies to provide third vaccine doses to people 16 and older.
In a rareon the eve of an FDA committee meeting, CEO Albert Bourla said both lab data and real-world evidence from Israel showed boosters can play an important role in addressing the pandemic.
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Dion Dawkins was hospitalized for four days after developing severe COVID-19 symptoms. Dawkins lost 16 pounds and might have an uphill battle to be ready by the time the Bills begin their season. “He’s not close to where he needs to be to play and help us,” McDermott said. “So he’s got a long road here. … He’s going to control what he can control, and so are we. He’s got to continue to work hard to get himself back to where he’s — I mean, this is what, going on Week 4 of training camp at this point, so he’s missed a lot of time.
"A booster of the same dose and the same vaccine can achieve this marked enhancement of protection," Bourla wrote in the letter, published on Pfizer's website Thursday morning.
FDA officials, however, appeared skeptical about the need for third shots for everyone at this point.
In briefing information provided to the committee and, the FDA emphasized studies supporting the need for boosters are not conclusive and were not conducted in the United States, which may see different results than other countries.
"Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States," the FDA report concluded.
In the United States, "still well over 90% of people" who are hospitalized with COVID-19 have not been vaccinated, though vaccinated people have begun to catch milder forms of the disease, CDC Director Dr. Rochelle Walensky said in a White House briefing last week.
What the potential Covid-19 booster rollout could look like
It's not clear if or when boosters doses of Covid-19 vaccines will be OK'd for fully vaccinated people in the United States, but state and local health departments across the United States are moving ahead with plans for a potential rollout next week. © Ben Hasty/MediaNews Group/Reading Eagle via Getty Images Reading, PA - September 14: A nurse fills a syringe with a dose of BioNTech, Pfizer COVID-19 vaccine. At the Reading Area Community College campus in Reading, PA Tuesday morning September 14, 2021 where Pennsylvania Gov.
It's not clear whether the committee members, all experts in aspects of vaccine development and immunology, will support these booster doses six months after initial doses.
Even if they do decide that third doses are safe and effective, it will be up to the Centers for Disease Control and Prevention and its own advisory committee –– to decide who should receive the boosters and on what schedule.
The agencies are considering only the Pfizer-BioNTech vaccine at the moment, which is the only fully approved shot, though they are expected to soon review the Moderna vaccine as well.
Fauci, speaking to a class of undergraduates Wednesday morning at the Massachusetts Institute of Technology, said he thinks it will turn out that people need three doses of the Moderna or Pfizer-BioNTech vaccines in order to get adequate long-term protection against COVID-19. Other diseases, such as hepatitis B, also require a three-dose vaccine regimen for full protection.
"We started with two doses because we needed to get the vaccine out there quickly to save millions of lives, which it already has done," he told the students. "But when we ultimately get down to looking at this, as the dust settles, it is my opinion and now many of my colleagues' that the proper complete regimen would be a three-dose regimen as opposed to a two-dose regimen."
Overnight Health Care — FDA panel backs boosters for some, but not all
FDA panel backs boosters for some, but not all Welcome to Friday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Are we living in Jumanji? All of the National Zoo's lions and tigers have been infected with COVID-19. And the zebras are still on the loose in Prince George's County. An FDA panel voted to recommend booster shots of Pfizer'sWelcome to Friday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.
Data from Israel, which Fauci cited, suggests that vaccine protection begins to fade over time, beginning at around six months, with vaccinated people becoming first more prone to mild disease, and then to increasingly severe disease.
Israel, where most people received the Pfizer-BioNTech shots, was one of the first countries to launch wide-scale vaccination against COVID-19 and so has some of the best data about how well those vaccines are holding up over time.
Israeli public health officials are expected to attend Friday's meeting of the Vaccines and Related Biological Products Advisory Committee to explain their findings in detail.
Other public health and vaccine experts are less persuaded by the available data.
"I'm convinced that protection against symptomatic infection wanes," said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia. But he's "less convinced about waning of protection against severe disease."
The purpose of vaccines is not to prevent every single symptom of infection, but to protect people against the most severe outcomes, said Dr. Anna Durbin, who studies experimental vaccines at the Johns Hopkins Bloomberg School of Public Health in Baltimore.
"Right now," she said on a Wednesday call with media, "the indication is that we don't need an additional booster."
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The United States is on track to exceed the total number of COVID deaths in July and August combined within a matter of days. Live updates.Through Saturday, the country reported 32,526 deaths in September, compared to 27,612 in all of August. With deaths averaging nearly 2,000 per day, the U.S. is on track to exceed the total deaths of July and August combined within a matter of days, a USA TODAY analysis of data from Johns Hopkins University shows.
There's no doubt that boosters are effective. "Will it improve your immune response? Will we see higher titers of antibody? Yes. Do the safety data look good? Yes. Does that mean we need boosters? No."
She added, "and we shouldn't be giving a valuable resource just because we can," noting it won't be possible to stop COVID-19 from coming into the United States unless the virus is stopped around the world.
In his letter, Pfizer CEO Bourla said a decision about boosters should be based on science, not concerns about equitable distribution. The introduction of boosters won't alter how many doses each country receives, he said.
"No commitments already made by Pfizer to a country will change if boosters are approved," he said. "We will honor each and every one."
His letter also noted booster doses were effective against the extremely contagiousthe COVID-19 infections in the U.S. Studies show adding a third dose – the same vaccine at the same dose of the first two shots – boosts protection against all variants of the virus.
Fauci told the students he's relieved the original vaccine provides protection against a wide range of variants; otherwise, he said, "you'd be playing whack-a-mole with every new variant."
A third dose would be as safe as the first two, according to Pfizer-BioNTech data, with roughly the same side-effect profile. There is no information on third doses in 16 and 17-year-olds, but the companies think they are similar enough to those over 18 that they should be covered by a booster approval as well.
Report: Buccaneers' Antonio Brown positive for COVID-19, unlikely to play at Rams
Brown is fully vaccinated against COVID-19, meaning he can return to team activities if he stays asymptomatic and produces two negative virus tests 24 hours apart. Nevertheless, Arians added he's preparing as if both Brown and Minter won't be available against the Rams. Brown leads Tampa Bay with 23.0 yards per catch on six receptions and is second on the team with 138 receiving yards this season. He caught one touchdown over the first two games of the campaign, both Tampa Bay wins. The Rams are also 2-0 on the campaign. Subscribe to Yardbarker's Morning Bark, the most comprehensive newsletter in sports.
Only Pfizer-BioNTech booster shots are being considered now because their vaccine is fully licensed by the FDA. Moderna and Johnson & Johnson vaccines are still available only under an emergency use authorization.
Moderna, which Fauci said is likely to receive full approval soon,Wednesday in support of boosters at six months.
One study,, showed the vaccine prevented 87% of cases of COVID-19 and avoided 96% of hospitalizations. About half the people in the study were exposed to the delta variant.
Another study, which has not yet been peer reviewed, followed people who were in the company's initial study of vaccine effectiveness, in which half the volunteers received the active vaccine and half a placebo. At the end of the trial they were vaccinated as well, meaning they got their shots months after the first group.
Among the more than 14,000 people in each group, those who received their shots earlier were more likely to catch COVID-19 and to develop severe disease. Three people who received earlier shots were hospitalized and one died, suggesting that protection against severe disease begins to wane over time.
There is no data yet on whether people who received the single-dose J&J vaccine need a second shot.
Contact Karen Weintraub at firstname.lastname@example.org and Elizabeth Weise at email@example.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY:
FDA authorizes Pfizer booster for people 65 and over; Iowa sets new 2021 high for coronavirus hospitalizations: COVID-19 updates .
Health care workers, teachers and grocery workers are among the high-risk workers eligible for a Pfizer booster. The latest COVID-19 updates:Individuals 18 and up who are at high risk for severe COVID-19 were also included in the authorization, which only covers those who are at least six months out from their second dose of the COVID-19 vaccine.