Federal regulators are working to develop a plan to distribute COVID-19 booster shots to the general population amid the spread of the delta variant and studies that suggest the vaccines' efficacy may wane over time.
Five updates on the U.S. booster plan:
- The U.S. will likely start distributing Pfizer COVID-19 booster shots starting the week of Sept. 20, but Moderna's will likely take longer, Anthony Fauci, MD, the White House's chief medical adviser, said Sept. 5, according to CNBC.
The FDA and CDC may not have enough time to review data on Moderna's shot by Sept. 20, Dr. Fauci said. For people who received two doses of Moderna's vaccine, Dr. Fauci said it's better to wait for Moderna's approval rather than getting a Pfizer booster, CNBC reported. - The FDA said Sept. 1 that it plans to convene its vaccine advisory committee Sept.17 to discuss a third dose of Pfizer's COVID-19 vaccine for people ages 16 and older. The agency's Vaccines and Related Biological Products Advisory Committee will meet virtually, and the agency said it will livestream the meeting from its YouTube channel and its website.
The vaccine advisory committee is made up of a chair, members with scientific, medical and public health expertise and a consumer and industry representative. The FDA said it will make the meeting agenda and committee roster available to the public two business days before the meeting is scheduled. - Moderna has asked the FDA to approve a lower dose of its vaccine for a booster, people familiar with the matter told The Wall Street Journal.
The drugmaker has reportedly asked the agency to authorize a 50-microgram dose, half the dosage of the first two shots. One potential benefit of a lower dose would be fewer side effects, and it would allow Moderna to make as many as 1 billion more doses than it could make of the higher dose, according to the Journal.
But it could also cause confusion, as pharmacists would have to prepare doses in different ways. Some federal regulators are concerned the lower dose may not offer enough protection against virus variants, the Journal reported. - CDC Director Rochelle Walensky, MD, and acting FDA Commissioner Janet Woodcock, MD, recommended the U.S. delay its booster shot rollout during a Sept. 2 meeting with White House COVID-19 response coordinator Jeff Zients.
The officials said the FDA needs more time to collect and review data on booster shots' safety and efficacy, people familiar with the discussion said. - Unlike the first COVID-19 vaccine rollout last December, most nursing homes won't rely on pharmacy chains to deliver booster shots this fall, Biden administration officials have said.
Almost all nursing homes in the U.S. have told the government they're planning to work with long-term care pharmacies instead of retail chains like CVS Health and Walgreens to get booster shots for its residents when they are authorized by the FDA.
When the COVID-19 vaccine rollout started last December, the U.S. government contracted with pharmacy chains CVS and Walgreens to deliver the shots to nursing homes. Some officials complained that the rollout was too slow, and thousands of doses intended for nursing homes went unused.