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Dr Peter Marks, one of the Food and Drug Administration’s most senior regulators, took over the agency’s vaccine office on Monday, whose two executives had publicly asked whether the general population needed booster vaccines. against coronaviruses.
Dr Marks said in an email to staff that the move, which makes him the acting director of the office, would allow the two – Marion Gruber, the director of the vaccine bureau, and Dr Philip Krause, his deputy – to “take care of the pre-departure closing activities and help ensure a smooth transition.”
Dr Gruber recently announced his intention to retire at the end of October, and Dr Krause in November.
The two have evaluated vaccines for decades at the agency’s vaccine research and review office, and were reportedly upset by the Biden administration’s announcement last month that booster shots would be available for the most part. of adults by the week of September 20, subject to FDA. authorisation.
The two regulators wrote in The Lancet earlier this month that there was no credible evidence yet to support the booster injections for the general population, and that more data and public discussion was required. Their position was shared by many independent scientists, who said coronavirus vaccines continue to be powerfully protective against serious illness and hospitalization.
After a tense meeting of the FDA’s Vaccine Advisory Group, Dr Gruber last week signed the agency’s decision note behind its authorization of Pfizer-BioNTech recalls for people 65 years of age and older, those with high risk of severe Covid-19 and others at risk of serious complications from Covid-19 whose professions frequently expose them to the virus.
The CDC’s vaccine advisory committee cast a similar vote, but did not approve the offer of recalls based on its work. Dr Rochelle P. Walensky, director of the agency, dismissed the advisers and recommended shots to people based on “professional or institutional background”.
President Biden said last week that 60 million people would be eligible for a Pfizer-BioNTech recall in the coming months.
The FDA’s office of vaccines has more important decisions to make, including whether or not to approve the Pfizer-BioNTech vaccine for children aged 5 to 11 and recalls for Moderna and Johnson & Johnson vaccine recipients.
As director of the FDA’s Biologics Assessment and Research Center, Dr. Marks, hematologist and oncologist, oversaw the vaccine bureau’s reviews for the entire pandemic. He is credited as the architect of the Trump administration’s vaccination program, Operation Warp Speed, which developed and funded coronavirus vaccines.
But Jesse Goodman, the agency’s former chief scientist, said Dr Marks’ decision to take over the office was “extremely unusual and concerning.” He said the FDA had to offer a clear explanation otherwise it could “erode trust” in the agency. “It just doesn’t make sense to me,” he said.
Understanding the mandates of vaccines and masks in the United States
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- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people 16 years of age and older, paving the way for increased tenure in the public and private sectors. Private companies increasingly require vaccines for their employees. Such warrants are authorized by law and have been confirmed in court challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of their immunization status, wear masks in indoor public places in areas affected by epidemics, a reversal of guidelines it offered in May. . See where the CDC guidelines would apply and where states have instituted their own mask policies. The battle for masks has become controversial in some states, with some local leaders defying state bans.
- College and universities. More than 400 colleges and universities require students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California and New York City have both introduced vaccination mandates for education staff. A survey released in August found that many American parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who don’t. don’t have their vaccines.
- Hospitals and medical centers. Many hospitals and major health systems are requiring their employees to be vaccinated against Covid-19, citing an increase in the number of cases fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their hand -work.
- New York City. Proof of vaccination is required from workers and customers for indoor meals, gymnasiums, shows and other indoor situations. On September 27, a federal appeal committee overturned a decision that suspended the mandate that teachers and other education workers in the city’s vast school system will be required to have at least one dose of the vaccine, with no possibility of weekly testing. . Employees of the city’s hospitals must also get vaccinated or undergo weekly tests. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon has announced it will seek to make coronavirus vaccination mandatory for the nation’s 1.3 million active-duty soldiers “no later than” mid-September. President Biden announced that all federal civilian employees should be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
“These are the two people who know the most about vaccines at the FDA, and they should do everything possible to keep them involved in all critical activities,” he said, referring to Dr Gruber and the Dr Krause.
Some administration officials said Dr Marks’ action made sense as the upcoming departures of Dr Gruber and Dr Krause could delay critical vaccine decisions if no one else was in charge. Dr Eric Topol, professor of molecular medicine at Scripps Research in La Jolla, Calif., Praised Dr Marks’ experience and said “new leadership was vital” after Dr Gruber and the Dr. Krause had expressed it so strongly that the booster shots were not warranted for everyone.
But Dr Luciana Borio, the former acting chief scientist of the FDA under President Barack Obama, said Dr Marks could have brought in someone else. “There are several well qualified people in the office,” she said, “and I was surprised that one of them was not promoted to acting director.”
An FDA spokeswoman said in a statement Monday that “a smooth transition is especially important given the critical regulatory submissions that the Office of Vaccines Research and Review will need to work on as a team over the next few months, which will affect the health of almost all Americans. “
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