Booster approvals for J&J and Moderna hang in the balance as FDA panel meets

Many Americans who got the Moderna or J&J COVID-19 vaccines have been on the edge of their seats waiting to find out if they’ll be able to get a booster. This week, the FDA will be much closer to making a decision for both shots.

This morning, an FDA advisory panel is meeting to discuss the prospects of a Moderna booster shot. Ahead of the meeting, Moderna argued that although its two-shot regimen remained effective at preventing severe COVID-19 and death, a booster could help maintain protection against mild to moderate cases.

Ultimately, the independent panel will vote today on whether or not to recommend a Moderna booster for certain population groups, and early indications show that most likely, it will at least be recommended for patients 65 and older.

Tomorrow, the panel will shift its focus to J&J’s vaccine. Some vaccine analysts have long held that J&J recipients will need a booster to maintain an adequate level of immunity. But scientists from the FDA said this week that they have concerns with some of the data in J&J’s application.

Among the issues raised was a test to measure the immune response that J&J used. According to a report in Reuters, the test has not been validated and the agency is concerned that it wasn’t sensitive enough to generate meaningful data. FDA scientists also pointed out that J&J used small sample sizes in its studies and that its data may not provide enough information on how well the vaccine performs against the Delta variant — which has become the dominant strain around the globe.

Meanwhile, research released this week by the NIH showed that patients who initially received a J&J shot had much stronger immune responses to boosters from either Moderna or Pfizer than they did from another J&J shot.

But Friday’s panel will ultimately be asked to vote on whether or not they believe a J&J booster will increase an immune response when administered six months after the first shot.

After the panels make their recommendations about both shots, it’ll be up to both the FDA and CDC to approve boosters.