Public health experts have said that the agency’s review of a Pfizer-BioNTech pediatric dose would be closely scrutinized. According to a recent survey conducted by the Kaiser Family Foundation, roughly a third of parents of children between ages 5 and 11 said they would wait and see before allowing their children to receive the shot.
The State of Vaccine Mandates in the U.S.
- Vaccine rules. On Aug. 23, the F.D.A. granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for mandates in both the public and private sectors. Such mandates are legally allowed and have been upheld in court challenges.
- College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
- Schools. California became the first state to issue a vaccine mandate for all educators and to announce plans to add the Covid-19 vaccine as a requirement to attend school, which could start as early as next fall. Los Angeles already has a vaccine mandate for public school students 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which went into effect Oct. 4 after delays due to legal challenges, appears to have prompted thousands of last-minute shots.
- Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get vaccinated. Mandates for health care workers in California and New York State appear to have compelled thousands of holdouts to receive shots.
- Indoor activities. New York City requires workers and customers to show proof of at least one dose of the Covid-19 for indoor dining, gyms, entertainment and performances. Starting Nov. 4, Los Angeles will require most people to provide proof of full vaccination to enter a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, in one of the nation’s strictest vaccine rules.
- At the federal level. On Sept. 9, President Biden announced a vaccine mandate for the vast majority of federal workers. This mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services.
- In the private sector. Mr. Biden has mandated that all companies with more than 100 workers require vaccination or weekly testing, helping propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
Dr. Walt A. Orenstein, an epidemiologist at Emory University and a former director of the U.S. immunization program, said that given the competing pressures on the F.D.A. to make vaccine decisions quickly but carefully, public discussion was essential.
He said many parents were wavering between fear of Covid-19 and fear of side effects from a pediatric vaccine. If they were less worried about the consequences of coronavirus infection, he said, concerns about possible side effects would be their top priority. If they were more worried, the vaccine’s effectiveness would matter more. As with other vaccines, Dr. Orenstein said, pediatricians would play a critical role in easing parental anxiety.
Pfizer’s clinical trial for children was not intended to draw meaningful conclusions about the vaccine’s ability to prevent disease or hospitalizations. Instead, researchers looked at antibody levels, comparing them with those that had conferred high protection in adults. Regulators are expected to compare the immune responses with vaccine efficacy data in the adult population.
The trial included 2,268 children, two-thirds of whom had received two doses of the vaccine three weeks apart. The remaining volunteers were injected with two doses of a saltwater placebo. Regulators over the summer asked for the trial size to be expanded to 3,000 children.
At a virtual panel on Covid-19 last week, Norman Baylor, the former director of the F.D.A.’s vaccines office, said that the number of participants in Pfizer pediatric study was noticeably small. The adult trial involved about 44,000 people.
“It does beg the question of the size, given what we have for the adults: Would one expect more for the pediatric population?” he said. “They may be thinking, ‘Well, we know the vaccine is safe, because look at how many people we had in the adults.’ But as we know, things may shift in that pediatric population.”