The City of San Francisco has said its roughly 44,500 employees must be fully vaccinated within 10 weeks of F.D.A. approval. The State University of New York, with roughly 400,000 students, is on a parallel track.
A number of health care systems have issued similar mandates to employees, including Beaumont Health, the largest health provider in Michigan, with 33,000 employees, and Mass General Brigham in Massachusetts, with about 80,000 workers.
Full approval typically requires the F.D.A. to review hundreds of thousands of pages of documents — roughly 10 times the data required to authorize a vaccine on an emergency basis. The agency can usually complete a priority review within six to eight months and was already working on an expedited timetable for the Pfizer vaccine. The F.D.A.’s decision to speed up was reported last week by Stat News.
In a guest essay in The Times last month, Dr. Peter Marks, the agency’s top vaccine regulator, wrote that undue haste “would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”
The regulators want to see real-world data on how the vaccine has been working since they authorized it for emergency use in December. That means verifying the company’s data on vaccine efficacy and immune responses, reviewing how efficacy or immunity might decline over time, examining new infections in participants in continuing clinical trials, reviewing adverse reactions to vaccinations and inspecting manufacturing plants.
At the same time, senior health officials at the F.D.A. and other agencies are grappling with whether at least some people who are already vaccinated need booster shots. Several officials are arguing that boosters will be widely needed before long, while others contend that the scientific basis for them remains far from settled.
Two people familiar with the deliberations, speaking on the condition of anonymity, said that if booster shots are needed, the administration wants a single strategy for all three vaccines currently authorized for emergency use.