The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to exceed emergency use status in the United States.
The decision will trigger a cascade of vaccine requirements by hospitals, colleges, businesses and other organizations. United Airlines recently announced that its employees must show proof of vaccination within five weeks of regulatory approval.
Oregon has adopted a similar requirement for all state workers, as have many universities in states from Louisiana to Minnesota. The Pentagon has said it will mandate the firing for the country’s 1.3 million active troops once Pfizer approves.
The approval comes as the country’s fight against the pandemic has intensified again, with the highly contagious Delta variant hurting the progress the country had made in the first half of the year. The Biden administration hopes the development will motivate at least some of the approximately 85 million unvaccinated Americans eligible for injections to get them.
“While millions of people have already received safe Covid-19 vaccines, we recognize that for some, FDA approval of a vaccine can now inspire additional confidence to get vaccinated,” said Dr. Janet Woodcock, the acting FDA commissioner, in a statement. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”
Pfizer said it has submitted data to the FDA from 44,000 participants in clinical trials in the United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective at preventing infection — a slight drop from the 95 percent efficacy the data showed when the FDA decided to approve the vaccine for use in December. in case of emergency. Pfizer said the drop was the result of researchers having more time to catch people who became infected.
A recent poll by the Kaiser Family Foundation, which has monitored public attitudes during the pandemic, found that three in ten unvaccinated people said they would be more likely to be vaccinated with an injection that was fully approved. .
The Pfizer-BioNTech vaccine remains authorized for emergency use for children ages 12 to 15, while Pfizer collects the necessary data needed for full approval. A decision on whether or not to authorize the vaccine for children under 12 years of age could take at least several months. To date, more than 92 million Americans — 54 percent of those who are fully vaccinated — have received Pfizer injections. Most of the rest received Moderna’s vaccine.
dr. Peter Marks, the FDA’s chief vaccine regulator, said the Pfizer vaccine’s licensure followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. “The public and the medical community can be confident that while we approved this vaccine quickly, it was fully consistent with our existing high standards for vaccines in the US,” he said.
The FDA is in the midst of a decision-making marathon regarding coronavirus vaccines. The next major question that arises for regulators is whether or not to authorize booster shots. The Biden administration said last week that, pending agency approval, it will offer third injections to adults who have received the Pfizer and Moderna vaccines starting Sept. 20, eight months after their second injection.
Understand the State of Vaccine and Mask Mandates in the US
- Mask Rules. The Centers for Disease Control and Prevention recommended in July that all Americans, regardless of vaccination status, wear masks in indoor public places in areas with outbreaks, a reversal of the guidance it offered in May. Find out where CDC guidelines apply and where states have their own masking policies. The battle over masks has become controversial in some states, with some local leaders defying state bans.
- Vaccine rules. . . and Buselessness. Private companies are increasingly mandating coronavirus vaccines for employees, taking different approaches. Such mandates are permitted by law and have been confirmed in court proceedings.
- College and universities. More than 400 colleges and universities are demanding that students be vaccinated against Covid-19. Nearly all of them are in states that voted for President Biden.
- schools. On August 11, California announced that teachers and staff at both public and private schools should be vaccinated or tested regularly, the first state in the nation to do so. A survey published in August found that many U.S. parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who have not received their injections.
- Hospitals and Medical Centers. Many hospitals and major health systems require workers to receive a Covid-19 vaccine, citing the increasing caseload fueled by the Delta variant and persistently low vaccination coverage in their communities, even within their workforce.
- New York. On August 3, New York City Mayor Bill de Blasio announced proof of vaccination would be required from employees and customers for indoor meals, gyms, performances and other indoor settings, becoming the first U.S. city to require vaccines for a wide variety of activities. . City hospital employees should also receive a vaccine or be tested weekly. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced it would aim to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “by mid-September.” President Biden announced that all civilian federal employees would be required to be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
Federal health officials said both Pfizer-BioNTech and Moderna vaccines, which rely on similar technology, are declining in strength over time. That trend, they said, has coincided with the rise of the particularly dangerous Delta variant, leaving those who completed their vaccinations at the beginning of the year increasingly vulnerable to infection.
Some health experts have challenged the decision to recommend booster shots as premature, as the data shows that the vaccines hold up well against severe illness and hospitalization, including the Delta variant. Boosters would only be justified if the vaccines didn’t prevent Covid-19 hospitalizations, some of those experts have said.
Regulators are still reviewing Moderna’s application for full approval of its vaccine. That decision could take several weeks. Johnson & Johnson is expected to file for full approval shortly.