FDA authorizes second boosters of mRNA COVID-19 vaccines for adults over 50

The Biden administration will permit adults 50 and older to get a second round of mRNA COVID-19 booster shots if they so choose, an effort to blunt the next surge.

The Food and Drug Administration also authorized a second booster shot of the Pfizer-BioNTech vaccine for people 12 and older who have compromised immune systems and are not able to get full vaccine protection after three shots.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Federal regulators decided to authorize booster shots of the Pfizer-BioNTech and Moderna vaccines without convening a meeting of its panel of vaccine experts first, a move that has already angered healthcare experts skeptical of a fourth shot’s utility.

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“It’s like a judge issuing a verdict and then having lawyers make their arguments,” said Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine who has criticized the FDA’s eagerness to authorize more doses.

The shots will be made available to those who want them, but the FDA is not updating its vaccination recommendation to include a second booster dose yet.

The necessity of a second round of boosters is still up for debate. The mRNA vaccines have proven highly effective against severe illness and death, though their protection wanes over time. New variants are also increasingly able to sidestep the full force of the vaccines.

The most compelling data to support administering second booster shots come out of Israel, where government health experts reported that healthcare workers who received a fourth shot on top of two doses of an mRNA vaccine plus a booster at the height of the omicron outbreak were 43% less likely to develop symptoms than those who had not.

The latest variant of concern is an omicron offshoot, BA.2, which now represents nearly 86% of all sequenced cases globally, according to the World Health Organization. In the United States, BA.2 has not overtaken its sister subvariant BA.1, which drove the devastating omicron surge over the winter months. But it already accounts for more than 54% of sequenced cases nationally. In the Northeast, BA.2 has already overtaken BA.1 as the most dominant variant.

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BA.2, dubbed the “stealth omicron” strain due to a lack of certain genetic changes that make it distinguishable in PCR test results, could be as much as 30% more transmissible than the original omicron strain. It is not, however, believed to cause more severe illness than BA.1.

“If you had 3 shots and an Omicron breakthrough infection, there’s little need for getting a 2nd booster at this point. You’ve got some hybrid immunity and you can save an extra shot, if there’s ultimately supportive evidence for a later time,” said Eric Topol, a professor of molecular medicine at Scripps Research.

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