FDA to Consider Future of COVID Booster Doses

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March 21, 2022 — The FDA today announced its vaccines advisory committee will meet April 6 to discuss the future of COVID-19 booster doses and how to tell if a specific strain of the coronavirus needs its own vaccine.

The independent experts on the Vaccines and Related Biological Products Advisory Committee will be joined by representatives from the CDC and the National Institutes of Health. According to a statement from the FDA, no votes will be taken and no specific company’s vaccines will be discussed.

“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

Experts at the meeting will discuss what might make them change the vaccine formulas to target specific variants and when a booster dose should be given and to whom.

Infectious disease specialists are watching BA.2, the Omicron subvariant that appears to be more transmissible than the first strain. BA.2 is driving outbreaks across Europe and is becoming more common across the U.S.

BA.2 accounted for 23% of new COVID-19 cases for the week ending March 12, according to the latest estimate from the CDC, up from 13.7% the week before.

The FDA will give the public access to background material no later than 2 business days before the meeting.

The meeting will be livestreamed on the agency’s YouTube channel and made available as a webcast on the FDA’s website.

The CDC currently recommends vaccination and a booster for everyone 12 and older and two doses for children 5 to 11. People with weakened immune systems are already urged to get a second booster.

Moderna and Pfizer last week requested FDA approval for second COVID-19 booster shots. Moderna’s request was for all adults, and Pfizer’s was for those 65 and older.

Moderna wants to offer the fourth dose to a broad age range to give health authorities “flexibility” in deciding which age groups would benefit most, the company said in its application.

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