- The Washington Times - Thursday, September 16, 2021

Scientists are divided on whether the general population needs booster shots for their COVID-19 vacations, leaving President Biden‘s push for a third dose in limbo. But now it is crunch time for key federal advisers and agencies, who will render a verdict in the coming days.

Advisers to the Food and Drug Administration are set to convene Friday to discuss Pfizer-BioNTech’s application to provide a third dose to recipients who completed a two-dose course several months ago. The company cited data showing a robust antibody response against infection and disease among recipients in clinical trials.

Experts say there is a good chance the FDA will approve Pfizer’s application, but separate advisers to the Centers for Disease Control and Prevention will have a say in who gets a third dose when they convene next week.

“It’s important to note that the FDA‘s role is really to say can we use this, can we use this product or can we use this booster? It is the CDC who will decide whether or not they should be used,” Dr. Anna Durbin, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, told reporters in a midweek COVID-19 briefing.

“So even if FDA comes out and approves the use of boosters by saying they’re safe, and they do what they’re supposed to do, the CDC will still need to review and approve the use of boosters to say that they’re actually needed, and who they are needed for,” she said. “And it may be that they recommend it for different populations — the elderly, for instance, or people in nursing homes, we don’t know.”

The FDA and CDC don’t have to accept their advisory panels’ recommendations, but they generally do.

Mr. Biden wanted to kick-start the booster rollout for the Pfizer and Moderna versions of the vaccine the week of Sept. 20, which is Monday.

That timeline appears to be slipping, with the CDC’s Advisory Committee on Immunization Practices convening at midweek and experts saying they need more time to review Moderna’s data. That means Pfizer likely will be the first to see its booster approved.

The administration is worried about data suggesting immunity wanes after several months, resulting in more breakthrough infections and potential hospitalizations down the road. It pointed to parallel data in Israel, which got an early start on vaccination, and top U.S. health officials a month ago backed a Biden plan to provide boosters to anyone who received a second dose at least eight months ago.

“We really rely on the people who are leading our health and medical agencies,” said White House press secretary Jen Psaki. “There is broad agreement about where things stand.”

FDA professionals, the World Health Organization and other experts pushed back, however, saying they haven’t seen data that show the general population needs boosters to stay out of the hospital. They said extra doses should be sent to poor nations that need them.

Papers and studies in recent days offered conflicting views on boosters, deepening the confusion.

The New England Journal of Medicine published a study that found older Israelis who received a booster were less likely to be infected or experience severe disease. Fewer infections could lessen worry about COVID-19 and break up chains of transmission. But the vaccines were primarily designed to stave off severe disease, so the virus turns into something like a common cold instead of a major problem.

Two departing FDA officials on Monday said available U.S. evidence does not support giving booster shots to the general population. They said even though immunity wanes, the vaccines’ effectiveness “is substantially greater against severe disease than against any infection.”

“Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission and are themselves at the highest risk of serious disease,” the scientists wrote.

FDA staff declined to take a position on boosters in a document released Wednesday, saying they haven’t been able to review enough data and the shots are still effective at warding off hospitalization and death.

The CDC’s advisory panel may tailor its initial recommendations to health workers, the elderly and the medically frail. Mr. Biden‘s plan would start with those groups, anyway, since they were prioritized in late 2020 and early 2021, and people who received their doses the earliest are supposed to get boosters first.

Ms. Psaki said the administration will be ready to “operationalize” its plan once the ACIP weighs in.

“It’s always been pending the approval of the ACIP and the FDA,” she said. “We’ll see what the ACIP says and then we’ll be able to lay out for you where we go and what that means moving forward.”

Pressed on senior FDA officials who questioned the need for extra shots and decided to leave the agency, Ms. Psaki reiterated the pro-booster consensus among top health officials in the administration, including acting FDA Commissioner Janet Woodcock.

The booster debate is unfolding even as Mr. Biden champions a sweeping plan to require millions of workers to get their first shots.

Roughly 54% of the U.S. population is fully vaccinated against COVID-19. Three-quarters of eligible Americans aged 12 and older have come forward for at least one dose, yet Mr. Biden says the quarter who have resisted are causing damage by allowing the virus to proliferate.

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