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WASHINGTON — With a new surge of Covid-19 infections plaguing much of the United States, the Food and Drug Administration has stepped up the timeline to fully approve Pfizer-BioNTech’s coronavirus vaccine and aims to complete the process early next month. He said he joined the effort.

President Biden said last week that he expects a fully approved vaccine by early fall. But according to many people familiar with the plan, the FDA’s unofficial deadline is Labor Day or earlier. The agency said in a statement that its leaders acknowledged that the endorsement could inspire greater public confidence and took an “all-encompassing approach” to the business.

Giving final approval to the Pfizer vaccine, rather than relying on an emergency clearance granted by the FDA late last year, could help boost vaccine rates at a time when the highly contagious Delta variant of the virus is sharply increasing 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 vaccination once a vaccine is fully approved. Final approval can also help silence misinformation about the safety of vaccines and clarify legal issues regarding authorizations.

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

Although 192 million Americans—58 percent of the total population and 70 percent of the nation’s adults—have at least one vaccine vaccine, many remain vulnerable to the highly contagious, dominant Delta variant. The country is facing about 86,000 new infections per day, up 142 percent in just two weeks, according to the New York Times database.

End Surveys by the Kaiser Family FoundationFollowing public attitudes during the pandemic, it found that three in 10 unvaccinated people said they would be more likely to be vaccinated with a fully approved vaccine. But pollsters cautioned that most respondents don’t understand the regulatory process and may be looking for a “proxy” justification for not taking a chance.

Moderna, the second most widely used vaccine in the United States, filed for final approval of its vaccine on June 1. The company is still sending data, however, and hasn’t said when it will end. The third vaccine authorized for emergency use, Johnson & Johnson has yet to apply, but plans to do so later this year.

Full approval of the Pfizer vaccine will kick off a series of nationwide vaccine mandates. Like many other employees of federal agencies, civilians working for the Department of Defense must be vaccinated or regularly tested. But the military delayed issuing shooting orders for the 1.3 million active duty service members until the FDA took action.

The City of San Francisco said it has roughly 44,500 employees must be fully vaccinated Within 10 weeks of FDA approval. The State University of New York, with approximately 400,000 students, is on a parallel path.

A number of health systems have given workers similar entitlements, including: Beaumont HealthThe largest healthcare provider in Michigan with 33,000 employees and Mass General Brigham, in Massachusetts, with approximately 80,000 workers.

Full approval typically requires the FDA to review hundreds of thousands of pages of documents—roughly 10 times the data needed 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 expedited timeline for the Pfizer vaccine. The FDA’s decision to accelerate was last week. Statistics News.

In guest tryoutn Last month, The Times reported that the agency’s top vaccine regulator, Dr. Peter Marks wrote that excessive haste will “undermine the FDA’s legal responsibilities, affect public trust in the agency, and do little to combat vaccine hesitancy.”

Regulators want to see real-world data on how the vaccine has worked since authorizing it for emergency use in December. This means verifying the company’s data on vaccine efficacy and immune responses, reviewing how efficacy or immunity may decline over time, examining new infections in participants in ongoing clinical trials, reviewing adverse reactions to vaccines, and inspecting manufacturing facilities.

At the same time, senior health officials at the FDA and other agencies grapple with whether at least some people who are already vaccinated need booster vaccines. Some officials argue that boosters will soon be widely needed, while others argue that their scientific basis is far from established yet.

Two people familiar with the negotiations and speaking on condition of anonymity said that if booster shots were needed, the administration wanted a single strategy for the three vaccines currently allowed for emergency use.

They said different recommendations for boosters for different vaccines could confuse the public. Full approval of a vaccine and then authorizing a booster for it can also send conflicting messages about its effectiveness.

As the research continues, senior management officials increasingly believe that at least vulnerable populations, such as the immune-compromised and the elderly, will need them, according to people familiar with their thinking. However, when to apply them, which vaccine to use and who should be vaccinated are still debated.

In A study published online last weekPfizer and BioNTech scientists reported that the effectiveness of the Pfizer vaccine against symptomatic disease dropped from about 96 percent to about 84 percent four to six months after the second shot, but continued to provide strong protection against hospitalization and serious illness.

Management officials said Moderna and Johnson & Johnson must also submit data, and Moderna has been asked to do so quickly. Other studies, including data the government has collected on the rate of breakthrough infections among tens of thousands of people, including healthcare workers, will also influence their decision-making, officials said.

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

Pfizer’s decision to fully approve its vaccine will give doctors more freedom to prescribe additional vaccines for at least some Americans, including those with compromised immune systems. The CDC was investigating possible special programs for this group, but management officials said that once such an initiative begins, the Pfizer vaccine will already be fully approved and it has become clear that doctors may prescribe a third vaccine.

According to the CDC, about 3 percent of Americans — or about 10 million people by some estimates — have compromised their immune systems due to cancer, organ transplants, or other medical conditions. others do not produce the immune response to protect them from the virus.

Some people try to buy booster injections on their own from pharmacies or other providers without waiting for federal government approval. Authorities in Contra Costa County, which is home to 1.1 million people in Northern California, were so eager to offer boosters that on July 23, they told vaccine providers to give extra vaccines to anyone who wanted it “without further documentation or justification”.

Then, realizing that the policy violated FDA rules regarding vaccines allowed for emergency use, the county reversed that this week.

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