FDA aims to give Pfizer vaccine final approval by early next month

WASHINGTON – With a new wave of Covid-19 infections ravaging much of the United States, the Food and Drug Administration has accelerated its schedule to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by early next month, people involved in the effort said.

President Biden said last week that he expected a fully approved vaccine in early fall. But the unofficial FDA deadline is Labor Day or earlier, according to several people familiar with the plan. The agency said in a statement that its executives recognized the approval could inspire more public confidence and had “taken a holistic approach” to the work.

Giving final approval to the Pfizer vaccine – rather than relying on emergency clearance granted late last year by the FDA – could help increase inoculation rates at a time when the highly variant variant. transmissible Delta virus sharply increases the number of new cases.

A number of universities and hospitals, the Department of Defense and at least one major city, San Francisco, are expected to mandate inoculation once a vaccine is fully approved. The final approval could also help silence misinformation about vaccine safety and clarify legal issues regarding warrants.

Federal regulators have come under increasing public pressure to fully approve Pfizer’s vaccine since the company filed its application on May 7. dean of the Brown University School of Public Health said in an interview Tuesday. “And I find that confusing, given where we are as a country in terms of infections, hospitalizations and deaths.”

Although 192 million Americans – 58% of the total population and 70% of the country’s adults – have received at least one vaccine injection, many remain vulnerable to the ultracontagious and dominant variant Delta. The country averages nearly 86,000 new infections a day, an increase of 142% in just two weeks, according to a New York Times database.

Recent polls from the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they would be more likely to get vaccinated with a fully approved vaccine. But pollsters warned that many respondents did not understand the regulatory process and may be looking for a “proxy” justification for not getting the shot.

Moderna, the second most widely used vaccine in the United States, applied for final approval of its vaccine on June 1. But the company is still submitting data and has not said when it will end. Johnson & Johnson, the third vaccine cleared for emergency use, has yet to apply but plans to do so later this year.

Full approval of the Pfizer vaccine will launch a patchwork of immunization mandates across the country. Like most other federal agency employees, civilians working for the Department of Defense must be vaccinated or undergo regular testing. But the military has refrained from ordering shots at 1.3 million active duty members until the FDA acts.

The city of San Francisco said its roughly 44,500 employees must be fully immunized within 10 weeks of FDA approval. The State University of New York, with approximately 400,000 students, is on a parallel track.

A number of healthcare systems have given similar mandates to their employees, including Beaumont Health, Michigan’s largest healthcare provider, with 33,000 employees, and Mass General Brigham in Massachusetts, with around 80,000 workers.

Full approval typically requires the FDA to review hundreds of thousands of pages of documents, about 10 times the data required to authorize a vaccine in an emergency. The agency can usually complete a priority review within six to eight months and was already working on an accelerated schedule for the Pfizer vaccine. The FDA’s decision to step up was reported last week by Stat News.

In a guest essay in The Times last month, Dr Peter Marks, the agency’s principal vaccine regulator, wrote that excessive haste “would undermine the statutory responsibilities of the FDA, affect public confidence. in the agency and would do little to help combat vaccine reluctance ”.

Regulators want to see real data on how the vaccine works since they cleared it for emergency use in December. This means checking company data on vaccine efficacy and immune responses, examining how efficacy or immunity might decline over time, examining new infections in participants in ongoing clinical trials, examining adverse reactions from vaccinations and inspect manufacturing plants.

At the same time, senior health officials from the FDA and other agencies are wondering if at least some previously vaccinated people need boosters. Several officials argue that boosters will be badly needed before long, while others argue that their scientific basis remains far from established.

Two people familiar with the proceedings, speaking on condition of anonymity, said that if booster shots are needed, the administration wants a single strategy for the three vaccines currently licensed for emergency use.

Different recommendations on recalls for different vaccines, they said, could confuse the public. Full approval of a vaccine and then allowing a booster for it shortly thereafter could also offer conflicting messages about its effectiveness.

As research continues, senior administration officials increasingly believe that at least vulnerable populations like those with weakened immune systems and the elderly will need them, according to people familiar with their thinking. . But when to administer them, which vaccine to use, and who should be vaccinated are still under discussion.

In a study published online last week, scientists at Pfizer and BioNTech reported that the efficacy of Pfizer’s vaccine against symptomatic illnesses fell from about 96% to about 84% four to six months after the second injection. , but continued to provide robust protection against hospitalization and critical illness. disease.

Administration officials said Moderna and Johnson & Johnson also had to submit data and Moderna had been asked to do so quickly. Officials said other studies would influence their decision-making as well, including data the government collects on the rate of disrupting infections among tens of thousands of people, including healthcare workers.

Pfizer is expected to submit a recall request to the FDA this month. While the FDA could authorize such shots, the Centers for Disease Control and Prevention is expected to recommend them after a meeting of its committee of external experts.

A decision to fully approve Pfizer’s vaccine will give doctors more leeway to prescribe additional injections at least for some Americans, including those with weakened immune systems. The CDC had explored possible special programs for this group, but administration officials said it was becoming clear that by the time such an initiative was launched, the Pfizer vaccine would already be fully approved and doctors could prescribe. a third injection.

According to the CDC, about 3% of Americans – or about 10 million people, by some estimates – have weakened immune systems as a result of cancer, organ transplants, or other health problems. others do not produce the immune response that would protect them from the virus.

Some people try to get booster shots from pharmacies or other providers on their own, without waiting for the blessing of the federal government. Officials in Contra Costa County, home to 1.1 million people in northern California, were so keen to offer reminders that on July 23, they told vaccine suppliers to give people extra injections. who requested it “without requiring additional documentation or justification”.

Then, realizing that this policy violated FDA rules on vaccines allowed for emergency use, the county canceled it this week.

Jennifer steinhauer contributed reports. Susan C. Beachy contributed research.