FDA Expert Panel Unanimously Greenlights J&J’s COVID-19 Booster

A day after its unanimous vote in favor of Moderna’s COVID-19 booster shot, a panel of vaccine experts that advises the FDA also voted unanimously to grant Johnson & Johnson’s (J&J) COVID-19 booster shot Emergency Use Authorization (EUA).

The agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 19 to 0, that available data support the safety and effectiveness of a COVID-19 vaccine for use under EUA as a booster dose in individuals 18 years and older at least two months after a single-dose primary vaccination.

J&J had submitted several studies to the FDA, scrutinizing both a second dose after two or three months and a booster given at least six months after the first dose. The company’s data showed that a booster given six months led to antibody levels increasing nine-fold after one week, before reaching a 12-fold increase four weeks after getting the booster dose. But panelists were skeptical of that six-month data, noting it was only gathered from 17 patients.

When the subject turned to mixing and matching COVID-19 vaccines, VRBPAC did not hold a vote on the issue and opinions varied over the lack of efficacy data supporting this approach.

Ahead of last week’s meeting, researchers from the National Institutes of Health had released findings that showed such a “mix and match” approach using different COVID-19 booster vaccines is safe and effective. The findings, which were presented Friday, suggest that an extra shot of the Moderna or Pfizer/BioNTech jab induces greater immunity than another dose of the J&J vaccine (DID, Oct. 14).

The 458-person phase 1/2 study assessed antibody responses at two weeks and four weeks following administration of a booster. Individuals who received a two-dose Moderna or Pfizer/BioNTech primary series received either a Moderna, Pfizer/BioNTech or J&J booster, while those who received a single J&J shot were given an extra J&J, Moderna or Pfizer/BioNTech shot.

The study showed that an additional dose of the same vaccine as the primary series boosted antibody levels four- to 20-fold, while mixing and matching primary vaccines and booster doses boosted antibody levels six- to 76-fold.

On Thursday of last week, the same FDA panel voted to grant an EUA to Moderna’s 50-mcg mRNA booster for people age 65 and older, adults at high risk of severe COVID-19 and adults who are frequently exposed to COVID-19. The committee green-lighted administering the half-dose booster dose six months after the second full dose in the two-jab series (DID, Oct. 15).

This is the same authorization Pfizer-BioNTech got in September for their mRNA COVID-19 vaccine booster (DID, Sept. 23).

The FDA is reportedly holding off on authorizing use of Moderna’s COVID-19 vaccine in adolescents over concerns it could increase risk of heart inflammation, especially in younger men. The agency has been reviewing instances of the rare condition, known as myocarditis, in Moderna vaccine recipients following suspension of the jab in several Northern European countries, including Sweden, Denmark and Finland. At present it is unknown when the FDA will resume its review (DID, Oct. 7).

The Centers for Disease Control and Prevention’s vaccine advisory panel will meet on Thursday of this week to consider who should receive vaccine boosters, including an extra J&J dose if the FDA authorizes it ahead of that meeting. And the FDA’s expert panel will meet again on Oct. 26 to assess whether to support Pfizer’s request for an updated EUA covering use of its COVID-19 vaccine in children aged five to 11 years old. — Suz Redfearn