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Sunday, November 28, 2021

Key data on US J&J, Moderna Covid-19 boosters ‘weeks away’

By Chris Prentice

Washington – Data needed to determine the advisability of booster shots of the Moderna Inc and Johnson & Johnson COVID-19 vaccines is just weeks away, President Joe Biden’s chief medical adviser said on Sunday, as officials signaled they expected boosters would be recommended for a broad swath of Americans.

U.S. health regulators already have begun to consider a third dose of the Pfizer/BioNTech vaccine. A U.S. Food and Drug Administration advisory panel on Friday recommended a third shot of the two-dose Pfizer/BioNTech vaccine for people age 65 and older or at high risk of severe COVID-19, but declined to endorse boosters for the wider population.

People who have received the two-dose Moderna vaccine or one-dose J&J vaccine are still awaiting guidance on possible booster shots.

“The actual data that we’ll get (on) that third shot for the Moderna and second shot for the J&J is literally a couple to a few weeks away,” Anthony Fauci, the U.S. government’s top infectious disease expert and a Biden adviser, told NBC’s “Meet the Press” program.

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“We’re working on that right now to get the data to the FDA so they can examine it and make a determination about the boosters for those people,” Fauci added.

More data may also show a broader need for booster shots across the general U.S. population, Fauci said.

The United States leads the world in COVID-19 cases and deaths. Nearly 676,000 people have died during the pandemic in the United States, figures compiled by Reuters showed. An increase in U.S. cases and deaths in recent months has been most acute in areas with lower vaccination rates even as federal health officials implore vaccine holdouts to get their shots.

The FDA advisers declined to recommend a third dose of the Pfizer/BioNTech vaccine for people age 16 and older who received their second shot at least six months earlier. Though the FDA is not bound by the panel’s recommendation, it will take it into consideration when deciding on whether to recommend a third round of shots.

“This is not the end of the story,” Fauci told CNN’s “State of the Union” program.

“They’re going to continue to look at this, literally in real time,” Fauci added.

Biden announced in August the government’s intention to roll out booster shots for people age 16 and older, pending approval by the FDA and Centers for Disease Control and Prevention experts.

The FDA’s decision-making process does not negate the White House’s position favouring boosters, Fauci said.

Fauci urged that people beyond the group for which the FDA panel recommended boosters wait to get them until formal approval is given.

Francis Collins, director of the U.S. National Institutes of Health, said on the “Fox News Sunday” program that he expects it would “become clear over the next few weeks that administration of boosters may need to be enlarged,” citing existing data from the United States and Israel indicating waning vaccine effectiveness over time.


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