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Thursday, December 2, 2021

Pfizer asks U.S. regulators to authorize Covid-19 boosters for all adults




Pfizer has asked the U.S. Food and Drug Administration to extend its Covid-19 booster injection authorization to all adults in order to address concerns about the reduced immunity of people vaccinated before winter.

The US pharmaceutical company said on Tuesday that its request was based on the results of a late-stage trial involving more than 10,000 participants, which showed that the booster dose is 95% effective for symptomatic Covid-19.

Just a few months after Pfizer and its partner BioNTech made a similar request, the application will be reviewed by the FDA, which sparked a debate among officials about whether all Americans need boosters when vaccination rates in developing countries are very low. .

In September, regulators restricted the scope of the US strengthening plan to disadvantaged groups, saying that there was insufficient evidence that weakened immunity would cause young, healthy adults to develop higher levels of serious diseases.

But health experts said that this application is more likely to be approved because there is more evidence to support the need for enhanced injections to maintain adequate protection against the virus.

The FDA declined to comment on Pfizer’s application.

Last month BioNTech released the preliminary results of an enhanced trial with more than 10,000 participants who have completed the BioNTech/Pfizer program twice. The trial took place during the Delta variant epidemic, and the median time between the second and third vaccination was approximately 11 months.

The decision to approve a broader booster program will represent a victory for President Joe Biden, who is campaigning on a platform that is more effective than Donald Trump in responding to the coronavirus.

Biden initially proposed to provide booster injections to all adults from September 20, but was forced to back down due to concerns expressed by officials and outside experts.

Ali Mokdad, professor of global health at the University of Washington, said: “This is necessary to contain the pandemic, and it is encouraging news.”

“As vaccine-derived immunity weakens, boosters are needed to reduce the spread of the virus, especially during the expected winter surge.”

Due to the spread of highly infectious Delta variants, the number of new Covid-19 cases, hospitalizations and deaths in the United States has been steadily declining since its peak in September. But some people worry that as people move indoors in the winter, a new wave of viruses may begin.

According to current US guidelines, people who have been vaccinated with BioNTech/Pfizer or Moderna vaccine are eligible for booster immunization six months after the second injection if they are 65 years of age or older. Anyone who is 18 years and older, has underlying medical conditions, or works or lives in a high-risk environment is also eligible for a booster.

Those who have received the Johnson & Johnson vaccine are eligible for booster shots two months after a single vaccination. Last month, US authorities allowed individuals to choose which type of vaccine they would like to receive as a booster.

Additional reporting by Kiran Stacey in Washington




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