Pfizer asks FDA to approve COVID-19 booster injections for all adults


Pfizer asked US regulators on Tuesday to allow anyone 18 years of age or older to get its COVID-19 vaccine because of concerns that holiday travel and gatherings will increase the spread of coronavirus.

Since September, American seniors and other groups particularly vulnerable to the virus have received a third dose of Pfizer and BioNTech vaccines. But the Food and Drug Administration said that if necessary, it will act quickly to expand the booster to a younger population.

Pfizer is submitting the early results of an intensive study of 10,000 people to prove that it is time to further expand the intensive activities.

Although all three vaccines used in the United States continue to provide strong protection against severe COVID-19 illness and death, over time, the effectiveness of these vaccines against mild infections may diminish.

New research by Pfizer concludes that even with a surge in delta variants with extra infectiousness, enhancers can restore protection against symptomatic infections to around 95%. The side effects are similar to those seen in the company’s two previous injections.

An average of 11 months after the last Pfizer vaccination, trial participants were given a third dose or sham injection. The researchers tracked any infections that occurred at least a week later. So far, 5 symptomatic COVID-19 cases have been counted among booster vaccinators and 109 among those who received fake vaccines.

The Biden administration initially envisaged providing boosters for all adults, but faced a severe setback in September when the FDA’s scientific advisers refused to provide everyone with an additional dose of Pfizer. The group does not believe that young and healthy people need another dose of vaccine, especially when most of the world’s population is still not vaccinated. Instead, it only recommends boosters for certain groups-this is a series of One of the three vaccine decisions to use additional doses.America

Current rules: People who were initially vaccinated with Pfizer or Moderna, if they are 65 years of age or older, or are at high risk of COVID-19 due to health problems, work or living conditions, are eligible to receive the booster vaccine six months later . Since the single-dose Johnson & Johnson vaccine has not proven to be as effective as its two-dose rivals, any J&J recipient can get the booster at least two months later.

In addition, anyone who is eligible for the booster vaccine does not have to stick to their original vaccination type and can obtain vaccines from different companies. This is called a mix and match.

Approximately 194 million Americans have been vaccinated. According to today’s policy, the authorities have estimated that in the next few months, about 2 out of every 3 vaccinated adults will be eligible for the booster vaccine. Many people who do not meet the criteria usually get an extra shot because many vaccine providers do not check eligibility.

If the FDA approves Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention will make recommendations on how to use them.

On a global scale, boosters are also a hodgepodge. Some countries restrict it to elderly or frail people, while others have almost no restrictions. For example, Israel allows anyone 12 years and older to use Pfizer boosters. Canadian health regulators authorized Pfizer on Tuesday to provide boosters for people 18 years and older.



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