FDA schedules April 6 meeting to devise next steps on COVID-19 boosters

The Food and Drug Administration said Monday it will hold an advisory meeting in early April to debate who should get additional COVID-19 booster shots in the coming months and whether the vaccines need to be tailored to specific variants.

Regulators said the outside advisers won’t discuss a specific application from any company or take a vote at the April 6 session.

But the decision underscores the need to offer some direction after nearly 100 million Americans opted for a third dose and are left to wonder if and when they should seek the fourth injection to restore waning immune responses.

Scientists have generally said a primary series from the vaccine should stave off the worst outcomes from COVID-19 in most people but recurring boosters would be needed for optimal protection against the virus, which is not going away anytime soon.

“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat.”

Pfizer and BioNTech recently requested FDA authorization for the fourth shot for persons 65 and older. They cited data from Israel that found persons who received another booster at least four months after the third shot were two times less likely to get infected and four times less likely to face severe illness.

Days later, Moderna upped the ante by requesting authorization for another booster for adults of all ages, fueling the debate around who needs a booster and when.

Dr. Marks said convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will help regulators determine the answers in a public forum.

“Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward,” he said.

The Centers for Disease Control and Prevention says 65% of the U.S. population, or 217 million people, received a primary vaccination series, defined as two doses of the Pfizer or Moderna vaccines or one shot of the Johnson & Johnson vaccine. 

About 45% of the fully vaccinated opted to receive an initial booster shot.

For more information, visit The Washington Times COVID-19 resource page.

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