A panel of vaccine advisers to the Food and Drug Administration voted unanimously Friday to recommend a booster shot of the Johnson & Johnson COVID-19 vaccine to everyone over the age of 18 who got the first shot at least two months ago.
The recommendation, which will go before the FDA and the Centers for Disease Control and Prevention prior to authorization, could pave the way for nearly 14 million Americans who received the J&J to get a booster shot.
According to data from the CDC, about 15 million Americans have received the J&J to date. Of those, nearly 91% received the vaccine more than two months ago.
The recommendation for the J&J booster came just one day after advisers recommended that the FDA authorize a reduced dose booster shot of the Moderna vaccine for people over the age of 65 and younger adults with underlying health conditions or occupational risks six months after receiving the two-dose series.
The recommendation for both shots will now be passed on for review by the FDA. Then the CDC’s vaccine advisors will be asked to review the data and recommendations before CDC Director Dr. Rochelle Walenksy stamps final authorization.
During Friday’s meeting, advisers considered study data submitted by Johnson & Johnson that showed a booster shot brings protection levels up to 94%, which is comparable to the efficacy shown in the Moderna and Pfizer when they were first given.
In addition to the study data, Johnson & Johnson also presented a research letter that was published in the New England Journal of Medicine on Friday as part of its request for emergency-use authorization of its booster dose.
The letter detailed an in-depth overview of the three vaccines currently available in the U.S. — Pfizer, Moderna and J&J. According to national reports, the research reveals that Pfizer’s peak antibody response occurs at two weeks and then sharply declines by six months, and Moderna’s vaccine elicits higher neutralizing antibody response than Pfizer’s but also drops dramatically around eight months.
Johnson & Johnson, on the other hand, did not produce a high antibody response when first given, but its response did not wane over time. The study notes that it’s not clear about what this means in terms of protection from infection and says more information is needed about which antibody responses correspond with real-life disease protection.
A number of FDA advisers agreed Friday that a booster shot was needed because the J&J vaccine has been proven to provide less protection than the Moderna or Pfizer vaccines.
“Regardless of whether or not (there’s) been waning or this is the true effectiveness after a single dose, the effectiveness or protection of a single dose of the J&J vaccine is not equivalent to protection at this time with either two doses of an mRNA vaccine and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine,” Dr. Amanda Cohn of the CDC said Friday.
The FDA advisers said Friday they did not see any evidence of serious safety concerns with the J&J booster, though they acknowledged that the panel did not have enough time to independently review all of the data that the company submitted in its authorization application.
The FDA’s top official, acting commissioner Dr. Janet Woodcock, is expected to issue the agency’s final determination on whether to authorize boosters within the next few days. Typically, the FDA follows its advisory panel’s recommendation.
After this authorization is declared, the recommendation will move to the CDC, whose advisers are expected to discuss the Moderna and J&J booster next Thursday and Friday.