FDA advisory panel unanimously approves J&J booster shot

A day after approving the Moderna COVID-19 booster shots, the advisory panel for the Food and Drug Administration is meeting Friday to consider the same for the Johnson & Johnson vaccine.

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Updated 1:31 p.m. EST, Oct. 15: The FDA advisory panel has approved the use of a booster shot for the J&J vaccine.

They recommended that the booster be given at least two months after the first dose, The New York Times reported.

There was some question about research used to support the decision, namely that the trial of the two-month timing. The study followed those who got the second dose were only followed for a short period of time, the newspaper reported.

Some members of the panel also questioned a test used to measure antibodies had a low sensitivity.

Regulators said there were no signs of serious safety issues by giving the second dose, but they also said that they didn’t have enough time to fully examine the data, the Times reported.

Some also said that the protection that the single-dose J&J shot wasn’t the same as the two-dose Pfizer or Moderna vaccines.

The panel still has to examine the possibility of a mix-and-match system of booster shots. That discussion will happen Friday afternoon.

Original report: The J&J vaccine is currently a one-vaccine treatment. But if approved, the treatment can become a two-dose treatment.

During the meeting, representatives from Johnson & Johnson will explain why a second shot should be dispensed. Federal regulators will also present their data, The New York Times reported.

A vote will come Friday afternoon.

There could be more of a debate over the J&J booster than was seen for the Moderna booster on Thursday.

Some regulators have questioned the company’s data and how it was gathered. They also said the government hasn’t had time to confirm the company’s findings, the Times reported.

>>Related: FDA advisory panel endorses Moderna COVID-19 booster shots for some people

The FDA advisory panel is also expected to look at the possible mixing COVID-19 vaccine brands. A study conducted by the National Institutes of Health found that those who received the J&J shot may benefit from getting either a Moderna or Pfizer-BioNTech booster. But CNN reported that a vote is not scheduled for the mix-and-match process today.

Once the panel votes, boosters will not immediately be approved. The head of the FDA must sign off on the policy. The Centers for Disease Control and Prevention also must approve the booster shot process. The CDC is scheduled to meet next week. After that panel decides, the head of the CDC must then sign off on the recommendation, the Times reported.

The states have the final say on how and when booster vaccines will be distributed, the Times reported.

On Thursday, the panel voted unanimously to recommend an emergency use authorization for a Moderna booster shot for people 65 or older and for those who are at high risk of COVID-19, CNN reported.

Check back throughout the day for the latest on this developing story.

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