The Food and Drug Administration’s independent panel of vaccine advisors is due to meet on Friday to discuss the case for booster shots of the Pfizer-BioNtech coronavirus vaccine, and to vote whether the agency should provide vaccines for people 16 and older. Additional doses should be approved.
The meeting and vote, which could significantly affect federal booster policy, comes amid a fierce debate within the Biden administration about whether booster shots are needed, and for whom. If the discussion reflects acrimony in administration, the expert committee could be divided, complicating the FDA’s decision.
The FDA is not obligated to follow the committee’s advice, but often does. Panel meetings to consider vaccine authorizations in the pandemic were mostly agreed, culminating in decisive votes in favor of the FDA’s presumed position.
President Biden’s Chief Medical Adviser Dr. Anthony S. Top federal health officials, including Fauci, have argued for weeks that fully vaccinated people are losing immunity against the infection, and that there are signs of reduced protection against more severe forms of COVID-19. .
In August eight of those officials signed a policy statement saying boosters would be needed and the administration was ready to distribute them to adults as early as the week of September 20, a decision some public health experts said. Said that was premature. But the White House has already been forced to delay giving boosters to recipients of Moderna’s vaccine, and for now it’s only planning a third shot for those who received the FDA-signed from Pfizer-BioNtech. Vaccine received.
There has been fierce resistance to the booster from some federal career scientists outside the government and many vaccine experts. Two major FDA regulators wrote in The Lancet this week that additional shots are not yet needed for the general population, assessing data from dozens of studies. One of them, Marion Gruber, who directs the FDA’s Office of Vaccines, is due to speak at Friday’s meeting.
Experts say vaccination is powerfully protective against severe illness and hospitalization due to COVID-19 in most people in all of the studies published so far. But the vaccines seem to be less potent against infection in people of all ages, especially those who have been exposed to the highly contagious delta variant.
The World Health Organization has asked world leaders to refrain from rolling out boosters until at least the end of the year, which aims to first vaccinate 40 percent of the global population. But some high-income countries have begun giving boosters to their residents, and others may follow their lead.
FDA Panel – Vaccines and Related Biological Products Advisory Committee – is Calm Independent scientific experts, infectious disease doctors and statisticians, many of whom participated in previous meetings about coronavirus vaccines.
is meeting set to start 8:30 a.m. Eastern Time and ends in the late afternoon. (You can watch it hereA “no” vote on Pfizer’s application could lengthen discussion and possibly prompt a separate vote, such as whether to recommend approving a booster for a more limited group.
Understand the Vaccine and Mask Mandate in America
- Vaccine Rules. On August 23, the Food and Drug Administration granted full approval to Pfizer-BioNtech’s coronavirus vaccine for people 16 and older, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly making vaccines mandatory for employees. such mandates legally permitted and has been upheld in court challenges.
- mask rule. In July the Centers for Disease Control and Prevention recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of guidance given in May. See where CDC guidance will apply, and where states have established their own masking policies. The fight over the masks has become controversial in some states, with some local leaders defying state restrictions.
- Colleges and Universities. More than 400 colleges and universities require students to be vaccinated against COVID-19. Nearly all are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for education workers. A survey released in August found that many American parents of school-age children are opposed to mandatory vaccines for students, but were more supportive of the mask mandate for students, teachers and staff members who have had their shots. are not.
- Hospitals and Medical Centers. Many hospitals and major health systems require employees to receive a COVID-19 vaccine, citing the growing caseload fueled by the Delta variant and stubbornly low vaccination rates in their communities, even as their Even within the task force.
- New York City. Indoor dining, gyms, performances and other indoor situations require proof of vaccination of workers and customers, although enforcement doesn’t begin until September 13. Teachers and other education workers in the city’s vast school system must have at least one vaccine. Dosage until September 27th without the option of weekly testing. City hospital staff must also get a vaccine or be subject to weekly testing. Similar rules apply for New York state employees.
- at the federal level. The Pentagon announced that it wants to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty soldiers “no later than” no later than mid-September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to routine testing, social distancing, mask requirements and restrictions on most travel.
The Centers for Disease Control and Prevention’s own vaccine advisory panel is set to meet next week, and may make recommendations on how additional doses should be used if approved by the FDA.
Dr. Sarah Oliver, a CDC official, is set to present to the FDA committee on Friday, as is Jonathan Stern, a British statistician who was one of the authors of the Lancet article. Later, Israeli officials will present 42 slide What they describe as clear signs that there is a marked decline in protection against COVID-19 in fully vaccinated people. Pfizer officials will also put up their side for booster shots.
As administration officials argue about the need for the shots, many Americans are taking matters into their own hands, calling for booster doses before federal approval.