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October 17, 2021
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US Health Officials Warn Booster Shots May Be Limited Initially

US Health Officials Warn Booster Shots May Be Limited Initially

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Top federal health officials have told White House officials that the plan to offer COVID-19 booster shots later this month may need to be limited at first, according to The New York Times .

FDA and CDC leaders said that third shots may only be approved initially for those who have received the Pfizer vaccine since regulators need more time to review data for the other vaccines.

In a meeting on Thursday, Janet Woodcock, MD, the FDA acting commissioner, and Rochelle Walensky, MD, the CDC director, told Jeffrey Zients, the White House pandemic coordinator, that the Biden administration may need to scale back its plan to offer booster shots to the general public in late September.

In the coming weeks, the FDA and the CDC may be able to determine whether to recommend a booster for the Pfizer vaccine, they said. But this recommendation won’t be for all COVID-19 vaccines and potentially only for some of the Pfizer vaccine recipients.

The Biden administration is waiting on a “full review and approval” of booster shots by the FDA, as well as a recommendation from the CDC, Chris Meagher, a spokesman for the White House, told The New York Times.

“When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus,” he said.

In mid-August, the Biden administration said booster shots would be offered to Pfizer and Moderna vaccine recipients who received their second shot eight months ago, according to The Washington Post . That would include health care workers, nursing home residents, and adults over age 65 who received the first coronavirus vaccine shots. The plan was scheduled to start the week of Sept. 20.

However, regulators need more time and data, the newspaper reported. Pfizer submitted its application to the FDA for booster shots last week. But FDA regulators want to see raw data from Israel, which has been giving booster doses of the Pfizer vaccine to ages 12 and older.

In addition, the FDA only has partial data about booster shots for the Moderna and Johnson & Johnson vaccines, The New York Times reported.

This week, two of the FDA’s top vaccine regulators announced that they would leave the agency this fall, the newspaper reported, partly due to frustration with the Biden administration’s booster plan. They both said there’s not yet enough data to justify offering extra shots.

The FDA’s advisory committee is scheduled to hold a public review of Pfizer’s data on Sept. 17. Pfizer has asked the FDA to approve booster doses for ages 16 and older, but the FDA could restrict who receives a third dose, the newspaper reported. Then the CDC’s advisory panel will meet to discuss the data.

“There is no compelling reason to get a third dose” at this point, Paul Offit, a member of the FDA’s advisory committee and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The New York Times.

Federal regulators are also looking at data on vaccine efficacy and whether protection wanes over time against the Delta variant. As more vaccinated people experience breakthrough infections, officials “want to be ready” with a booster plan, Woodcock said in a Coronavirus in Context interview with WebMD.

“The trends that we’re seeing in resistance to the virus and fully immunized people lend us to believe that at some point we’re going to cross that threshold and we’re going to see hospitalizations and more severe disease,” she said.

“And when that happens, we want to be ready,” she added. “We don’t want to have a couple more months where we have to get ready and make a plan and then execute against the plan.”

Sources:

The New York Times: “Health Officials Advise White House to Scale Back Booster Plan for Now.”

The Washington Post: “Top federal health officials warn that booster shots initially may be limited to Pfizer recipients.”

WebMD: “FDA on COVID-19 Vaccines for Kids, Boosters, and Treatments.”

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