- The Washington Times - Sunday, September 19, 2021

U.S. health officials said Sunday the “story is not over” after Food and Drug Administration advisers rejected President Biden’s push to provide everyone with COVID-19 booster shots, saying incoming data may prompt regulators to expand the campaign despite moves to limit extra doses to high-risk Americans for now.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the FDA advisory committee made a “fine” and “good” decision to support third doses for seniors, the medically frail and health workers on Friday. But he said those same advisers will get rolling reports from Israel, the U.S. and other countries to determine this year whether a broader swath of people need a third dose.

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

Dr. Fauci’s boss, National Institutes of Health Director Francis Collins, said the advisers’ decision is a “start” but they will probably expand the program in the coming months.

“They weren’t convinced yet that the data required this for younger individuals who aren’t at high risk. But I think some of the data we’re seeing coming in, especially from Israel, tells me that it’s likely that they will get to that point,” he told CBS’s “Face the Nation.” “But certainly, I think there will be a decision in the coming weeks to extend boosters beyond the list that they approved on Friday.”



Mr. Biden on Aug. 18 said he planned to let anyone who received two doses from Pfizer or 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 to help localities get ready.

The decision to set a date seemed to get ahead of regulators, sparking confusion and controversy.

Advisers on Friday voted, 16 to 2, to reject Pfizer’s application for widespread boosters, saying they need more data about the general population. The decision was viewed as a stark rebuke of Mr. Biden’s ambitions but his top health officials spun it Sunday as cracking open the door to a booster program.

The FDA panel did approve Pfizer boosters for people 65 and older, 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 many people will still get boosters. “You’re going to get a pretty good chunk of the population.”

Evidence shows that COVID-19 vaccines still protect against severe illness. Yet Biden officials are pushing boosters because they are skittish about signs of waning immunity from the initial doses.

William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, said surveillance data shows waning protection between five and 10 months after two doses of the Pfizer vaccine. If protection drops below 70% around five months, he said it would be expected to dip below 60% at 10 months. A third dose provides a “substantial boost” against the delta variant, similar to the original coronavirus strain, and recipients had comparable reactions to the vaccine’s second dose, he told the FDA advisers.

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 draw in the lines of what it means to be at high risk and in need of a booster. For instance, they might say teachers should get the vaccine, especially if they work with children under age 12 who aren’t eligible for the shots.

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

“They’re not being left behind by any means,” he told NBC’s “Meet the Press.

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.

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 their cohort, reportedly claiming to be coming forward for the first time.

Dr. Fauci said it is “unlikely” that seeking a booster is dangerous but it is still not a good idea to seek them outside of the process.

Even as he touts boosters, Mr. Biden is using employer-based mandates to try and lift rates 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.

Mississippi Gov. Tate Reeves said on Sunday that Mr. Biden is forcing workers to choose between a “jab in their arm and their ability to feed their families” to distract from mounting political problems at home and abroad.

Mr. Reeves’ state has the worst death rate from COVID-19 in the nation, but he said Mr. Biden is overstepping by requiring the vaccine for millions of health workers and instructing the Occupational Safety and Health Administration to fine large companies that don’t mandate the shots or weekly virus testing.

He knows he doesn’t have the authority to do this in my opinion, but he wants to change the political narrative away from Afghanistan and away from other issues that are driving his poll numbers in the ground,” Mr. Reeves, a Republican, told CNN.

He said his state is prepared to sue once it sees the OSHA rule and that people on “the left” should be fearful, too, after the president’s mandates reached into the private sector.

“What powers do we not grant this president? What does he not have the ability to do?” Mr. Reeves said.

Mr. Biden is cracking down as the U.S. reports about 145,000 new infections per day over a 7-day average, according to the CDC’s Dr. Sara Oliver. Speaking to the FDA panel, she noted that more than 660,000 in the U.S. have died from COVID-19 with about 1,300 new deaths each day over a 7-day average.

Dr. Fauci said widespread vaccination from the two-shot vaccines from Pfizer and Moderna or the one-shot J&J version 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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