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FDA aims for final approval of Pfizer vaccine by early next month

Washington — With the surge in Covid-19 infections in most parts of the United States, the Food and Drug Administration has accelerated its schedule for full approval of Pfizer-BioNTech’s coronavirus vaccine, completing the process by early next month. I am aiming to do it. He said he was involved in the effort.

President Biden said he was hoping for a fully approved vaccine in early fall last week. However, according to people familiar with the plan, the FDA’s informal deadline is Workers’ Day or earlier. Authorities said in a statement that the leaders “taken a full-scale approach” to the work, recognizing that approval could stimulate more public confidence.

Granting final approval for the Pfizer vaccine does not rely on the emergency permit granted by the FDA at the end of last year, but instead relies on the rate of inoculation at the moment the highly infectious delta mutant of the virus is exploding the number of new cases. May help boost.

Once the vaccine is fully approved, many universities and hospitals, the Pentagon, and at least one major city, San Francisco, are expected to require vaccination. Final approval can also help silence false information about vaccine safety and clarify legal issues regarding obligations.

Federal regulators have increased public pressure to fully approve Pfizer’s vaccine since Pfizer filed an application on May 7. The Dean of the Faculty of Public Health at Brown University said in an interview Tuesday. “And I think it’s confusing given where we are in the country in terms of infectious diseases, hospitalization, and death.”

192 million Americans (58% of the total population, 70% of adults) have been vaccinated at least once, but many remain vulnerable to the predominantly superinfectious delta mutant. is. According to the New York Times database, the country has an average of about 86,000 new infections per day, an increase of 142% in just two weeks.

Recently Opinion poll by Kaiser Family FoundationTracking public attitudes during the pandemic found that 3 out of 10 unvaccinated people said they were more likely to be injected with a fully approved vaccine. .. However, pollsters warned that many respondents did not understand the regulatory process and may have been looking for a “surrogate” justification to avoid being shot.

Moderna, the second most widely used vaccine in the United States, filed for final approval of the vaccine on June 1. However, the company has still submitted data and has not disclosed when it will end. Johnson & Johnson, the third vaccine approved for emergency use, has not yet been applied, but will be applied later this year.

Full approval of the Pfizer vaccine will begin a patchwork of vaccination obligations nationwide. Like most other federal employees, civilians working in the Pentagon need to be vaccinated or regularly inspected. However, the military postponed orders for shots of 1.3 million active duty soldiers until the FDA acted.

San Francisco City Announces Approximately 44,500 Employees Must be completely vaccinated Within 10 weeks of FDA approval. The State University of New York, with approximately 400,000 students, is moving forward in parallel.

Many healthcare systems issue similar obligations to their employees. Beaumont Health, Michigan’s largest healthcare provider, 33,000 employees, and General Brigham, Massachusetts, Approximately 80,000 Workers..

Full approval typically requires the FDA to review hundreds of thousands of pages of documents. This is about 10 times the data needed to approve a vaccine in an emergency. Agencies were usually able to complete priority review within 6-8 months and were already working on a rapid schedule of Pfizer vaccines.The FDA’s decision to speed up was reported by last week Statistical news..

and Guest essay in Last month, the Times reported that Dr. Peter Marks, the authority’s top vaccine regulator, said excessive haste “to undermine FDA legal liability, affect public confidence in the authorities, and combat vaccine hesitation. Will do almost nothing. “

Regulators want to see actual data on how the vaccine works since it was granted emergency use in December. That is, examine company data on vaccine efficacy and immune response to see how efficacy or immunity declines over time, and to identify new infections in participants in ongoing clinical trials. Investigate, identify side effects to vaccination, and inspect the manufacturing plant.

At the same time, senior health authorities at the FDA and other agencies are working on whether at least some people who are already vaccinated need booster shots. Some officials argue that boosters will soon be widely needed, while others argue that the scientific basis for boosters has not yet been determined.

Two familiar with deliberations speaking on anonymous terms say the government wants a single strategy for all three vaccines currently allowed for emergency use if booster shots are needed. Said.

They said that different recommendations for booster immunization of different vaccines could confuse the general public. If you fully approve the vaccine and then immediately approve its booster, you may receive inconsistent messages about its efficacy.

While research continues, government officials say at least those with a weakened immune system and vulnerable people like the elderly will need them, according to those familiar with their ideas. I believe more and more. But when to administer them, which vaccine to use, and who should receive the injections are all still debated.

of A study posted online last weekPfizer and BioNTech scientists found that the effectiveness of Pfizer’s vaccine against symptomatic illness decreased from about 96% to about 84% 4-6 months after the second shot, but for hospitalization and serious illness. He reported that he continued to provide strong protection.

Government officials said Moderna and Johnson & Johnson also needed to present the data, and Moderna was required to present it promptly. Authorities say other studies will also influence decision-making, including data the government is collecting on breakthrough infection rates for tens of thousands of people, including health workers.

Pfizer will submit a booster shot application to the FDA this month. The FDA can approve such shots, but the Centers for Disease Control and Prevention should recommend them after a meeting of an external expert committee.

The decision to fully approve Pfizer’s vaccine will give doctors more freedom to prescribe additional shots, at least for certain Americans, including those with a weakened immune system. The CDC was exploring possible special programs for the group, but by the time such an initiative began, the Pfizer vaccine had already been fully approved and doctors prescribed a third shot. He said it became clear that he could do it.

According to the CDC, about 3% of Americans, or an estimated 10 million, endanger the immune system as a result of cancer, organ transplants, or other medical conditions. Others do not produce an immune response that protects them from the virus.

Some people are trying to get their own booster shots from pharmacies and other providers without waiting for federal blessings. Officials in Contra Costa County, home to 1.1 million people in Northern California, were enthusiastic about providing boosters, so on July 23, they gave vaccine providers an additional shot “without the need for additional documentation or justification.” Instructed the people who requested to give additional shots.

The county then overturned it this week, noting that the policy violated the FDA’s rules for vaccines allowed for emergency use.

Jennifer Steinhower Contribution report. Susan C. Beach Contributed to the research.

FDA aims for final approval of Pfizer vaccine by early next month

Source link FDA aims for final approval of Pfizer vaccine by early next month

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