F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

WASHINGTON – In light of a new surge in coronavirus infections across much of the United States, the Food and Drug Administration has accelerated its schedule for full approval of Pfizer-BioNTech’s coronavirus vaccine, with the aim of completing the process by early next month, it said the effort.

President Biden said last week he expected a fully approved vaccine in early fall. However, according to several people familiar with the plan, the FDA’s unofficial deadline is Labor Day or earlier. The agency said in a statement that its leaders realized that the permit could create more public trust and that they had “taken an all-hands-on-deck approach” to the work.

The final approval of the Pfizer vaccine – rather than relying on the emergency clearance granted by the FDA late last year – could help increase vaccination rates in a moment when the highly transmissible Delta variant of the virus is causing the number of new cases to rise drifts up.

A number of universities and hospitals, the Department of Defense, and at least one major city, San Francisco, are expected to require vaccination once a vaccine is fully approved. The final approval could also help suppress misinformation about the safety of vaccines and clarify legal questions about mandates.

Federal regulators have been under increasing public pressure since the company’s application on May 7 to fully approve Pfizer’s vaccine, Brown University School of Public Health Dean said in an interview Tuesday. “And I find it baffling when you consider where we stand as a country in terms of infections, hospital admissions and deaths.”

Although 192 million Americans – 58 percent of the total population and 70 percent of the country’s adults – have received at least one vaccination, many remain susceptible to the ultra-contagious, dominant Delta variant. According to a New York Times database, the country averages nearly 86,000 new infections per day, a 142 percent increase in just two weeks.

Recent surveys by the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they were more likely to get vaccinated with a fully approved vaccine. Pollsters warned, however, that many respondents did not understand the regulatory process and may have sought “proxy” justification to avoid getting a chance.

Moderna, the second most widely used vaccine in the United States, filed for final approval for its vaccine on June 1. However, the company is still submitting data and has not said when it will be ready. Johnson & Johnson, the third emergency vaccine approved, has not yet applied, but is set to do so later this year.

Full approval of the Pfizer vaccine will trigger a patchwork of vaccination orders across the country. Like most other federal agency workers, civilians working for the Department of Defense must be vaccinated or regularly tested. But the military has been holding back ordering gunshots for 1.3 million active service members until the FDA acts.

The city of San Francisco has announced that its approximately 44,500 employees must be fully vaccinated within 10 weeks of FDA approval. The State University of New York with around 400,000 students is on a parallel path.

A number of health systems have given their employees similar mandates, including Beaumont Health, the largest healthcare provider in Michigan, with 33,000 employees, and Mass General Brigham, in Massachusetts, with approximately 80,000 employees.

Updated

Aug 3, 2021, 9:15 a.m. ET

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

In a guest article in the Times last month, Dr. Peter Marks, the agency’s senior vaccine regulator, said excessive rush would “undermine the FDA’s legal responsibilities, undermine public confidence in the agency, and do little to combat vaccine reluctance.”

Regulators want to see real-world data on how the vaccine has worked since they approved it for the emergency in December. That means reviewing the company’s data on vaccine effectiveness and immune responses, reviewing how effectiveness or immunity might decline over time, investigating new infections in participants in ongoing clinical trials, reviewing vaccine side effects, and inspecting manufacturing facilities .

At the same time, senior health officials from the FDA and other agencies are scrutinizing whether at least some people who have already been vaccinated need a booster vaccination. Several officials argue that boosters will soon be widely used, while others claim the scientific basis for this is far from being established.

Two people familiar with the deliberations said, on condition of anonymity, that the government wanted a single strategy for all three currently approved emergency vaccines when booster shots are required.

Different recommendations on boosters for different vaccines could confuse the public. The full approval of a vaccine and the subsequent approval of a booster vaccine for it could also provide contradicting statements about its effectiveness.

Understand the state of vaccine mandates in the United States

As the research goes on, senior government officials increasingly believe that at least vulnerable populations like those with compromised immune systems and the elderly will need them, according to people familiar with their mindset. But when they should be given, what vaccine to use, and who should be vaccinated are still debated.

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

Administration officials said Moderna and Johnson & Johnson were also required to provide data, and Moderna had been asked to do so quickly. Officials said other studies will also influence their decision-making, including data the government is collecting on breakthrough infection rates in tens of thousands of people, including health workers.

Pfizer is expected to file a booster vaccination application with the FDA this month. While the FDA could allow such shots, the Centers for Disease Control and Prevention would have to recommend them after a meeting of their external committee of experts.

A decision to fully approve Pfizer’s vaccine will give doctors more leeway to prescribe additional vaccinations, at least for certain Americans, including those with compromised immune systems. The CDC had been investigating possible special programs for this group, but administration officials said it had become clear that by the time such an initiative got underway, the Pfizer vaccine would be fully approved and doctors could prescribe a third vaccination.

About 3 percent of Americans – or an estimated 10 million people – have weakened immune systems as a result of cancer, organ transplants, or other illnesses, according to the CDC. others do not produce the immune response that would protect them from the virus.

Some people try to get booster vaccinations from pharmacies or other vendors themselves without waiting for the federal government’s blessing. Officials in Contra Costa County, home to 1.1 million people in Northern California, were so eager to offer booster vaccinations that on July 23, they asked vaccine providers to give those who asked for additional vaccinations “without further documentation or needing justifications ”.

Then, when it realized the policy violated FDA rules for vaccines approved for emergency use, the county overturned this week.

Jennifer Steinhauer contributed the reporting. Susan C. Beachy contributed to the research.

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