Wednesday, October 20, 2021

US drug regulator advisors to meet on Moderna, Johnson & Johnson COVID-19 vaccine boosters

A panel advising the Food and Drug Administration (FDA) is set to meet this month to consider whether to recommend booster shots of the Moderna and Johnson & Johnson COVID-19 vaccines.

The Vaccines and Related Biological Products Advisory Committee will meet on October 14 and October 15 to consider whether to recommend the Moderna and Johnson & Johnson boosters for certain groups.

Advisors will hear presentations on both days, including from both companies. Another presentation from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases will outline data on mixing and matching boosters, or using a different vaccine for the booster, the FDA said in a press release.

The administration usually takes recommendations from its panel. The Biden administration announced last month that it supports using boosters for everyone who has received the vaccine, regardless of their health status or underlying characteristics. However, the FDA only authorized the Pfizer COVID-19 vaccine booster in certain populations after two top FDA officials announced their resignations, writing a paper on their way arguing that there was no evidence to support their use. There was no evidence.

The authorization only applies to people who received Pfizer’s initial two-shot regimen. Mixing and mixing of boosters is not recommended at this time.

Tensions over the booster continued after the FDA agreed with its advisors. The Centers for Disease Control and Prevention advisory board rejected a vote to recommend a booster for millions of people under the age of 18, but the agency’s director, Dr. Rochelle Valensky, rejected it.

Read Also:  Moderna mRNA vaccine approved in Australia for children 12 years and older

Moderna and Johnson & Johnson have said that scientific data allows for higher doses of their vaccines.

Moderna released partial results from a trial in mid-September that said people benefit from increased protection against infection from a third dose of its shot, even as the company said data. Little has been shown against hospitalization and death.

Johnson & Johnson said nearly a week later that data from a Phase III clinical trial showed the second shot of its vaccine provided protection against symptomatic COVID-19.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, gave a fresh signal ahead of an advisory committee meeting on the FDA’s position on the booster.

“Available data clarify that protection against symptomatic COVID-19 appears to decline over time in some populations, so it is important to evaluate information on the use of booster doses in different populations,” he said.


Zachary Steber covers US news including politics and court cases. He started out as a New York City subway reporter at The Epoch Times.


This News Originally From – The Epoch Times

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