US President Joe Biden leaves after providing an update on his administration’s response to the coronavirus disease (COVID-19) in the South Courtroom of the Eisenhower Executive Building at the White House in Washington, June 2, 2021.
Carlos Barria | Reuters
A major part of President Joe Biden’s plan to combat Covid-19 is at risk as the Food and Drug Administration’s Vaccine Advisory Committee meets Friday to discuss and vote on the Pfizer and BioNTech app to deliver booster footage to the general public.
The agency’s Advisory Committee vote on Vaccines and Related Biological Products — scheduled for around 2:30 p.m. ET — comes as some scientists, including at least two at the U.S. Food and Drug Administration, say they aren’t entirely convinced every American who has received the Pfizer vaccine needs to additional doses at this time.
In documents released before the advisory committee meeting, FDA scientists declined to take a position on supporting the third shot, saying that US regulators had not independently reviewed or verified all available data to support the use of boosters. They also appeared skeptical about some of the data presented, including efficacy numbers that were widely cited outside of Israel, where researchers have released observational studies showing that the effectiveness of the Pfizer vaccine against infection has waned over time.
It sets the stage for a tense meeting on Friday in which the Biden administration said it wants to start providing enhanced footage to the general public as early as next week, pending authorization from the Food and Drug Administration. The move is part of the administration’s broader plan to tackle a greater number of Covid cases in the United States fueled by the rapidly spreading delta variant.
The country’s top health regulators, including CDC Director Dr. Rochelle Wallensky, Acting Food and Drug Administration Commissioner Dr. Janet Woodcock and White House medical advisor Dr. Anthony Fauci, endorsed Biden’s enhanced plan in August. While the Food and Drug Administration hasn’t always followed its committee’s advice, it often does. The agency surprised investors and the public earlier this year when it walked away from the advice of its independent team of outside experts to approve Biogen’s Alzheimer’s drug.
If the committee does not provide an affirmative vote, it could force the Biden administration to change its plan, possibly limiting the third shot to certain groups of Americans, such as those 65 and older who are known to be at high risk. disease, said Lawrence Justin, director of the WHO Collaborative Center on National and Global Health Law.
Justin said the FDA group could give Biden’s boosted plan “a fantastic reception.” “While there is good evidence that vaccine immunity may be diminished, two doses of mRNA hold up powerfully by preventing serious illness, hospitalization and mortality.”
Dr. Bruce Farber, head of infectious diseases at Northwell Health, said the vote puts the committee in a “critical position” as the administration has already announced it will begin distributing the boosters in the week of September 20.
“I’m sure they will not be unanimous at all in what they said because we already know that they are not unanimous,” he said.
Scientists and other health experts had already criticized Biden’s move to promote all Americans 16 and older when top health officials outlined the plan last month. Scientists and other experts said the data cited by federal health officials was not convincing and called the administration’s push for reinforcements premature.
In outlining plans to begin distributing the boosters as early as next week, administration officials cited three CDC studies that showed vaccine protection against Covid waned over several months. The management plan calls for people to get a third dose of the Pfizer or Moderna vaccine eight months after the second shot. Biden has since said scientists are studying whether the third shot should be raised by three months. US health officials have said they need more data about Johnson & Johnson’s vaccine before they can recommend boosters for those injections.
Both Pfizer and Moderna also released their own analyzes showing the incidence of advanced Covid cases — which occurs in fully vaccinated people — was less frequent in clinical trial participants who were recently vaccinated, suggesting that the protection of Covid vaccines wanes over time. In separate documents released Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine six months after the second shot restores protection against infection to 95%.
However, some scientists argue that there is no need for booster doses for the general public at this time.
A leading group of scientists published a paper Monday in the medical journal The Lancet that said available data show that the vaccine’s protection against severe disease persists, even as efficacy against mild disease wanes over time. The authors, including two outgoing senior FDA officials and multiple WHO scientists, said widespread distribution of the booster shots to the general public was “not appropriate” at this time.
There is currently no consensus in the biomedical community about boosters for the general public, said Dan Baruch, an immunologist at Harvard Medical School. “There are great experts who fall into different sides of the debate.”
Arturo Casadevall, chair of the department of molecular microbiology and immunology at Johns Hopkins University’s Bloomberg School of Public Health, supports reinforcers for the general public.
A third dose, he said, will boost immunity and should reduce the potential for infections, including with different strains. “For all vaccines, immunity wanes over time and Covid-19 vaccines are no different.”
Immunologist at Yale University School of Medicine Akiko Iwasaki disagrees with the widespread distribution of boosters in the United States. She said we should focus on giving the first shots to everyone else around the world before moving on to the booster doses.
She said booster doses are still needed for some of the most vulnerable people at the moment as advanced cases lead to severe illness and hospitalization.
These severe cases “mostly occur in the elderly and the elderly, such as 65 years and over,” she said. “I think giving it to seniors really makes sense to me now.”