Wed. Dec 1st, 2021


Pfizer has asked the US Food and Drug Administration to expand authorization of its Covid-19 booster shot to all adults in a move to address concerns about dwindling immunity for vaccinated people before winter.

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

The application will be reviewed by Pfizer and its partner by the FDA only months after a similar request BioNTech sparked a controversial debate among officials over whether boosters were needed by all Americans at a time when vaccination rates in the developing world were very low.

In September, regulators limited the scope of the U.S. booster program to vulnerable groups, saying there was not enough evidence that declining immunity would lead to higher levels of serious illness among young, healthy adults.

But health experts suggest the application is more likely to be authorized this time around, as there is more evidence to support the need for a booster shot to maintain adequate protection against the virus.

The FDA declined to comment on Pfizer’s application.

Last month, BioNTech released preliminary results from the booster trial of more than 10,000 participants, which completed a two-shot BioNTech / Pfizer regime. The trial took place during a period when the Delta variant was common, and the median time between second and third doses was about 11 months.

A decision to approve a broader booster program would represent a victory for President Joe Biden, who campaigned on a platform to tackle coronavirus more effectively than Donald Trump.

Biden initially proposed making booster shots available to all adults from September 20, but was forced to withdraw due to concerns expressed by officials and external experts.

“It is necessary and encouraging news to control the pandemic,” said Ali Mokdad, a professor of global health at the University of Washington.

“With declining vaccine-acquired immunity, enhancers are needed to reduce the spread of the virus, especially during the expected winter boom.”

The number of new Covid-19 cases, hospitalizations, and deaths in the U.S. has been steadily declining since peaking in September, due to the spread of the highly contagious Delta variant. But there are concerns that a new wave of the virus could start if people move indoors during the winter.

Under current US guidelines, people who have been vaccinated with either the BioNTech / Pfizer or Moderna syringes are eligible for a booster six months after receiving their second shot when they are 65 years of age or older. Anyone 18 years and older who has underlying medical conditions or works or lives in high-risk environments is also eligible for a booster.

People vaccinated with the Johnson & Johnson sting eligible for a booster shot two months after their single vaccine dose. Last month, U.S. authorities gave the green light to individuals to choose what type of vaccine they would like to receive as a booster.

Additional post by Kiran Stacey in Washington



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