COVID-19 Resource Center

COVID-19 Resource Center

Perspective from Lawrence O. Gostin, JD
Source:

FDA. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement. Accessed Oct. 15, 2021.

Disclosures: Lyke reports receiving NIH funding for her involvement in the study. The authors report no relevant financial disclosures. Marks reports no relevant financial disclosures.
October 15, 2021
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FDA committee recommends second J&J shot at 2 months

Perspective from Lawrence O. Gostin, JD
Source:

FDA. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement. Accessed Oct. 15, 2021.

Disclosures: Lyke reports receiving NIH funding for her involvement in the study. The authors report no relevant financial disclosures. Marks reports no relevant financial disclosures.
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An FDA advisory committee on Friday unanimously recommended that anyone who received the Johnson & Johnson COVID-19 vaccine should be able to receive a second dose at least 2 months after receiving their initial shot.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-0 to recommend the booster shot at 2 months despite Johnson & Johnson’s request that it be offered at 6 months.

Source: Adobe Stock.
Source: Adobe Stock.

The vote came near the end of a 2-day meeting for the VRBPAC, which unanimously recommended on Thursday that the FDA authorize a half-dose booster of Moderna’s COVID-19 messenger RNA vaccine for people aged 65 years or older and younger people with risk factors.

Whereas the Moderna recommendation aligned with what the FDA had already authorized for booster doses of the Pfizer-BioNTech mRNA vaccine, the VRBPAC’s recommendation for the Johnson & Johnsons shot was much broader. If it is adopted by the FDA, it would mean that anyone aged 18 years or older who received the shot could get a second dose of the vaccine, not just prioritized groups.

Some VRBPAC members took issue with the language the committee voted on Friday, which asked if data supported the safety and effectiveness of the Johnson & Johnson vaccine for use under an emergency use authorization (EUA) “as a booster dose.” Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research, said the FDA would take it under advisement that some members preferred the word “additional” rather than “booster,” given the second shot’s proximity to the first.

If the FDA authorizes the Johnson & Johnson booster, which it is expected to do, the CDC’s Advisory Committee on Immunization Practices will make clinical recommendations for the shot. That committee has a 2-day meeting scheduled for next week.

In addition to hearing data Friday about the impact of boosting the Johnson & Johnson vaccine, the VRBPAC listened to a presentation by Kirsten E. Lyke, MD, associate professor of medicine at the University of Maryland, on the results of an NIH study assessing the mixing and matching of COVID-19 vaccines.

The study found that, among 458 participants, people who received a booster dose of a vaccine different than the vaccine they received for their primary series experienced protection that was similar to or greater than people who received the same vaccine as a booster, “meaning that the heterologous had as good or higher neutralizing antibodies following the boost” as homologous vaccination, Lyke said Friday.

Marks noted before the presentation that the VRBPAC would not be voting on recommendations for mix-and-match combinations of vaccine boosters. However, he did not close the door on a future vote.

The FDA advisory committee will meet next on Oct. 26 to discuss Pfizer and BioNTech’s application for an EUA for its COVID-19 vaccine for children aged 5 to 11 years. The vaccine is fully approved for people aged 16 years or older. Through an EUA, it has also been available for those aged 12 to 15 years since May.

References:

Atmar RL, et al. medRxiv. 2021;doi:10.1101/2021.10.10.21264827.

FDA. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement. Accessed Oct. 15, 2021.