A key advisory body to the Food and Drug Administration overwhelmingly opposed the recommendation of Pfizer booster vaccinations for most recipients of the company’s coronavirus vaccine, and instead only endorsed it for those 65 or older or at high risk for severe Covid-19 19 have.
The vote – the first on boosters in the United States – was a blow to the Biden government’s strategy of providing additional vaccinations to most fully vaccinated adults in the United States eight months after receiving a second dose. The broader rollout should begin next week.
Committee members seemed to reject the argument that the general population needed booster vaccinations, saying the data from Pfizer and elsewhere still seemed to show two vaccinations that protected against serious illness or hospitalization and did not prove a third vaccination was preventing the spread contain the infection. Some also criticized the lack of data that an additional injection is safe for younger people.
“It is unclear that everyone needs topping except for a subset of the population who would clearly be at high risk for serious illness,” said Drs. Michael G. Kurilla, a committee member and officer for the National Institutes of Health.
But the panel’s final recommendation left some space for the White House to argue that the core of its booster strategy remains intact. Depending on how “high risk” is defined, It is conceivable that tens of millions of Americans could be eligible for additional vaccinations from the Pfizer vaccine.
The panel of largely external experts voted 16-2 against a Pfizer booster for people aged 16 and over after a tense, day-long public discussion in which the divisions within the agency and administration were publicly displayed. Officials from the Centers for Disease Control and Prevention and the National Institutes of Health, along with infectious disease experts and doctors, voted against additional shots for such a broad population.
Dr. Paul Offit, a committee member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, asked if additional shots would go much further in changing the arc of the pandemic. “We all agree that we have to vaccinate the unvaccinated if we really want to influence this pandemic,” he said.
However, the panel unanimously passed a fallback position to limit additional admissions to the elderly and others at high risk of severe Covid disease. Then, following an informal survey conducted by a senior FDA official, committee members determined that health care workers, emergency responders, and others whose jobs put them at particular risk should also be eligible for the booster. The official – Dr. Peter Marks, who oversees the FDA’s vaccines division – said the at-risk group would also include teachers.
Biden staff noted that under the White House plan to offer booster syringes eight months after the second injection, the same group would come first as they were vaccinated earliest.
The FDA has the final say in approving vaccines, and while it is not required to follow the committee’s recommendations, it usually does. The agency is expected to make a decision early next week.
Understand US vaccination and mask requirements
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, a reversal of the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
- College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for educational staff. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students but are more likely to support masking requirements for students, teachers, and staff who are not vaccinated.
- Hospitals and medical centers. Many hospitals and large health systems require their employees to receive a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
- New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13th. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, with no weekly testing option. Municipal hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.
A CDC advisory committee is due to meet on Wednesday and Thursday to discuss booster injections before this vaccine policy-making agency makes recommendations on who should get them.
Critics of the government’s booster strategy as too far-reaching or premature said the advisory committee acted as a necessary check on Friday.
The meeting “put the FDA back in the driver’s seat,” said Dr. Luciana Borio, a former acting chief scientist at the agency. The panel of experts, she said, “should retain its scientific independence. She understands that the data presented has significant limitations and that the FDA must carefully review the data before making a decision. “
Apoorva Mandavilli and Sheryl Gay Stolberg contributed the reporting.