FDA Panel Approves Moderna Booster for People 65 and Older and High-Risk Adults

AP Photo/Rogelio V. Solis

An independent advisory panel unanimously approved a booster shot for Americans who have received both doses the Moderna COVID-19 vaccine. The shot will be recommended for those who are 65 and older as well as high-risk patients such as those who suffer from heart disease or breathing disorders.


The FDA is expected to accept that recommendation in a matter of days.

The Pfizer vaccine booster was approved in September. Another advisory committee to the Centers for Disease Control and Prevention that makes recommendations on how vaccines should be used is scheduled to meet Wednesday.

Booster shots have been controversial given the paucity of real-world experience with the vaccines. But clinical studies have shown a significant fall-off in the antibodies created by the vaccines to fight the coronavirus — enough so that those at risk for serious disease or death could benefit from a booster.

Washington Post:

Some health experts have argued that there is not enough evidence to justify administering boosters to certain populations, especially younger, healthier people who, if they become infected, are likely to have asymptomatic or mild infections. But several Biden health officials believe it is important to reduce cases in vaccinated people, even if they do not result in hospitalization, to bring down the overall caseload.

At the start of Thursday’s advisory committee meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, outlined the potential rationale for boosters. He said all three of the vaccines available in the United States remain highly protective against severe outcomes but added that even milder cases may warrant prevention.

The CDC has reported that as of October 4, 2021, there have been 30,177 breakthrough infections out of 185 million fully vaccinated Americans. A breakthrough infection is defined as a fully vaccinated individual who contracts COVID-19.

A large percentage of those breakthrough cases were among those 65 and older and the immuno-compromised, such as transplant patients and people on chemotherapy treatment for cancer.

But the medical community is by no means unanimous in recommending a booster shot.

Several of the advisers pushed back on the notion that extra shots are needed for all Americans and said they worried the emphasis on boosters could distract from the potential of standard vaccine regimens to end the pandemic, which has killed more than 720,000 people in the United States.

“The effect of a booster is much less than vaccinating unvaccinated individuals — that means both here and abroad,” said Eric J. Rubin, editor of the New England Journal of Medicine and a member of the advisory committee. “If we want to get out of this thing, we’ve got to vaccinate the unvaccinated.”

The WHO has been criticizing the entire idea of booster shots, believing that boosters are a luxury in a world where so many have yet to be vaccinated. The booster is about half the dosage of the vaccine but the shipping and distribution problems for Third-World countries remain the biggest obstacle to vaccinating the world.

Both the Pfizer and the Moderna vaccines need to be stored at very low temperatures in specialized freezers. Once they are removed from the refrigeration units, they’re viable for only for a few days. This would make it impossible to vaccinate most of the world.

The Johnson & Johnson vaccine might be the answer. It needs only normal refrigeration to be shipped and stored. But J&J has had a lot of problems with very serious side effects and its future is in doubt.

The FDA will consider the Pfizer vaccine for children under 12 years old in the next few weeks and may approve its use on an emergency basis by the end of the month.



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