“We just got things turned around,” said Dr. Jesse L. Goodman, a former chief scientist at the Food and Drug Administration. “The administration and the leaders of the scientific agencies who signed on got out in front of any public discussion, airing of the data or vetting of it. That put the F.D.A. and the C.D.C. and their advisory committees in a corner.”
Dr. Woodcock, the acting F.D.A. commissioner, privately warned that it was risky to announce a timetable, especially for multiple vaccines, according to people familiar with the discussions. The F.D.A. and the C.D.C. meetings in the coming days and Pfizer’s application for approval of its booster dose appear to be conforming to the timetable the administration proposed in August.
Like other senior health officials, Dr. Woodcock had hoped that booster shots could be offered this month not only for Pfizer and Moderna recipients, but for recipients of Johnson & Johnson’s one-dose vaccine as well, according to people familiar with the deliberations. But the administration had to limit its plan to Pfizer recipients, officials said, because neither Moderna nor Johnson & Johnson delivered the expected data in time.
While Mr. Biden publicly noted that his strategy depended on regulatory action, he also made the plan sound all but definite. “It’s simple,” he said at the time. “Eight months after your second shot, get your booster shot.”
In interviews, senior administration officials defended the decision to specify a date for the rollout, saying that precious time would have been lost if pharmacies, providers and state officials were not prepared.
The data from Israel, which offered boosters first, was particularly concerning to U.S. health officials.
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- Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
- 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. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.
- Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
- New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
In the New England Journal of Medicine article on Wednesday, researchers said they analyzed health records of more than 1.1 million people in Israel who had received both doses of the Pfizer vaccine at least five months earlier. They found that the rate of severe disease among people over 60 who had received a third shot at least 12 days earlier was nearly twentyfold lower than among those who had received two injections.
Source Article from https://www.nytimes.com/2021/09/15/us/politics/booster-shots-fda.html
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