FDA panel to tackle J&J, Moderna boosters
Citing waning immunity and the threat of coronavirus variants, both Moderna and Johnson & Johnson are seeking clearance for a booster dose, and a Food and Drug Administration panel will tackle the topics at the end of this week, setting up a potential green light sometime next week.
The Vaccines and Related Biological Products Advisory Committee will meet on Thursday and Friday to discuss the two companies’ applications for booster shots, which follows recent clearance for Pfizer’s booster.
In briefing documents released Tuesday, Johnson & Johnson asked the FDA for authorization of a booster in adults 18 and older with two different options — a booster at two months, or six months after the first shot.
The company said that a six-month booster is recommended, but that a second dose could be given at two months in some situations. The company had previously announced that its booster increased protection against severe COVID and increased the strength of the immune response against variants.
In the U.S., the boosted population has a vaccine efficacy of 94%, whereas the single-dose vaccine efficacy is 73%, according to J&J data.
Shortly after J&J’s singleshot vax was given to the general public, the Centers for Disease Control and Prevention paused the rollout, citing concerns over blood clots. FDA regulators are likely to ask about this issue with respect to the booster shot during the upcoming meeting.
Also in Johnson & Johnson news, the company announced Tuesday that Dr. Paul Stoffels, chief scientific officer, will retire at the end of this year.
Taking a page out of Pfizer’s book, Moderna asked the FDA to clear its booster in the same groups for which it was authorized for Pfizer, which includes people 65 and older, those with certain medical conditions and people facing workplace exposure.
The FDA did not indicate Tuesday if it was leaning toward clearing the company’s booster. It said vaccines used in the U.S. still provide protection, and it raised questions about some of Moderna’s data.
The initial Moderna doses are 100 micrograms each, but Moderna makes an argument for a 50-microgram booster, saying it will stretch supply further and still offer good results.
Moderna’s booster was shown to increase neutralizing antibodies by activating immune memory responses, according to briefing documents.
There still remain several steps before the boosters can make their way into the public. After the FDA panel meets, an independent CDC committee will also meet to discuss the data. Then, CDC Director Dr. Rochelle Walensky will need to sign off on the rollout plan.