The Food and Drug Administration’s vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, and we are getting our first look at the data the panel will be using to make its recommendation on booster shots for Moderna and Johnson & Johnson.
Both companies believe booster doses are justified, given studies showing a drop in antibody levels over time after people completed their initial vaccination.
There is also evidence that variants like delta are challenging that protection even more.
More: Next on FDA’s agenda: Booster shots of Moderna, J&J vaccines
Moderna is specifically requesting authorization for a booster dose at least six months from the initial series. That is one-half the dose given during the initial vaccination. Its data shows at that dose, a booster will effectively increase protective antibody levels while potentially decreasing side effects.
Moderna also believes the lower booster dose will help stretch global vaccine supply at a time when much of the wold remains unvaccinated.
Following the footsteps of Pfizer’s recent booster authorization, Moderna is requesting the same scope of use -- people age 65 and older, people ages 18-64 at high risk for severe COVID-19 and people ages 18-64 with frequent institutional or occupational exposures.
The request submitted by Johnson & Johnson asks for the same booster dose as the first vaccination. However, because they were initially a single-dose vaccine, they have collected data on giving their second, or booster dose, in one of two different intervals -- either two months after the first dose or six months after.
Johnson & Johnson’s data indicate that a booster given six months after the initial dose increases the immune response twelvefold compared to a boost at two months, which increases it four-six fold.
The rationale for giving some people a boost at two months and others at six months is to provide more immediate enhanced protection for people at higher exposure risk or at higher risk for severe disease.
Johnson & Johnson believes a six-month booster for everyone else would be best for maximal and long-lasting protection.
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