- The Washington Times - Sunday, September 19, 2021

Advisers to the Food and Drug Administration made a “good recommendation” in endorsing COVID-19 booster shots for seniors, health workers and high-risk persons, Dr. Anthony Fauci said Sunday, downplaying the decision to reject President Biden’s push to offer a third dose to everyone.

He said the “story is not over yet” and the same advisers will vet data as it pours in from Israel, the U.S. and other countries to determine later this year whether a broader swath of the population needs a boost.

“Data are literally coming in on a daily and weekly basis,” Dr. Fauci told CNN’s “State of the Union.” “They’re going to continue to look at this, literally in real-time.”

Mr. Biden in mid-August said he planned to let anyone who received a two-course regimen from Pfizer and Moderna get a third dose eight months after they receive their second doses. He said the program was subject to regulatory approval but announced a start date of Sept. 20 for the program, sparking confusion and pushback.

Advisers on Friday voted 16-2 to reject Pfizer’s application for widespread boosters, saying they need more data about the general population.

The panel did approve Pfizer boosters for people 65 and older and those at high risk of severe COVID-19 at least six months after they receive their second doses.

Advisers also said health care workers and other people in high-risk jobs should be included under emergency-use authorization.

The FDA is free to dismiss the recommendation but the agency tends to follow the panel’s advice.

“The FDA absolutely should not ignore them,” Dr. Fauci told CNN, saying he respects the decision and many people will get boosters. “You’re going to get a pretty good chunk of the population.”

The rejection of Mr. Biden‘s plan threatened to further confuse Americans who’ve been spun around by the novel coronavirus and federal scientists who are giving advice on the fly, as knowledge and data trickles in piecemeal.

Dr. Fauci dismissed the idea that Friday’s vote was a bruising hit for the president, pointing to the White House’s stated deference to regulators.

“It was always pending the evaluation of all of the totality of the data,” he said.

The FDA previously approved booster shots for people with compromised immune systems. Some people are reportedly freelancing and seeking out booster shots even though they haven’t been approved for them.

Dr. Fauci said it is “unlikely” that seeking a booster is dangerous but it is still not a healthy idea to work outside the framework.

“Scientifically, you don’t want to go by ‘unlikely,’ you want to have some scientific proof,” he said.

Dr. Fauci also said regulators will receive more data to discuss boosters for the Moderna and Johnson & Johnson versions of the vaccine in the coming weeks.

“The actual data that we’ll get that third shot for the Moderna and second shot for the J&J is literally a couple to a few weeks away,” Dr. Fauci told NBC’s “Meet the Press.” “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. They’re not being left behind by any means.”

Dr. Collins said the NIH is also trying to figure out if people can mix and match by getting a booster from a different drugmaker than the one that made their initial dose or doses.

Advisers to the Centers for Disease Control and Prevention will have a say on boosters later this week. The CDC’s Advisory Committee on Immunization Practices will potentially draw in the lines of what it means to be at high risk and in need of a booster. For instance, they might discuss whether teachers should get the vaccine, especially if they work with children under age 12 who aren’t eligible or the shots.

Mr. Biden is using mandates on parts of the workforce to try and lift the rate of initial vaccination before the colder months when respiratory diseases tend to proliferate. Roughly 55% of the U.S. population is fully vaccinated and about a quarter of those eligible for the shots — over 70 million people — have refused to get at least one dose so far.

Dr. Fauci said getting people vaccinated with their initial course is vital to controlling the pandemic.

“That doesn’t mean that is the optimal regimen. The optimal regimen might be three shots for everyone,” he said. “But right now, based on the data that was examined by the advisory committee, their decision, which I respect, is to go the way we just said, with having some limitations on it.”

Dr. Fauci, who is 80, said he will get his third dose after government agencies finalize the plan for high-risk groups.

“I will certainly get a booster,” Dr. Fauci said.

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