FDA panel votes in favor of J&J COVID booster shots for all adults. What to know

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A U.S. Food and Drug Administration advisory panel voted in favor of authorizing Johnson & Johnson COVID-19 vaccine booster doses for anyone ages 18 and older who already received one dose of the same shot.

The extra dose would be administered at least two months after receiving the first shot.

The FDA — which usually supports recommendations set by its advisory panel, but is not obligated to — must officially authorize J&J boosters for emergency use. This decision typically comes soon after the advisory panel declares its vote.

A Centers for Disease Control and Prevention advisory committee will also soon discuss safety and efficacy data of J&J booster shots, as well as who should receive them. If the committee recommends the extra dose, and if CDC Director Dr. Rochelle Walensky gives the green light, J&J boosters will immediately become available to millions of eligible adults in the U.S. who initially received the single-dose shot.

In a future meeting, the FDA panel will further discuss new research that shows J&J COVID-19 vaccine recipients gain more protection from a booster of either the Pfizer or Moderna vaccines instead. It’s unknown when or if mix-and-matching boosters will be authorized.

Friday’s decision was based on data that showed a booster dose of the J&J vaccine led to increased protection against coronavirus infection causing symptoms, highly contagious variants and severe/critical COVID-19, according to an FDA document released ahead of the Oct. 15 meeting.

Booster shots for the Pfizer COVID-19 vaccine have already been authorized for certain groups of people. The FDA advisory panel voted in favor of Moderna booster shots for some adults on Oct. 14, though the administration and CDC still have to officially sign off on it before they become available to those who are eligible in the U.S.

A CDC spokeswoman confirmed to CNN that its advisory committee plans to meet Oct. 20 and Oct. 21 to discuss booster doses for the Moderna and J&J vaccines.

Data shows protection from single J&J dose doesn’t wane over time

Real-world evidence in the U.S. — meaning data collected outside of laboratory settings — shows protection against severe COVID-19 from just one dose of the J&J vaccine does not decrease six to eight months after vaccination, which is not the case for the Pfizer and Moderna shots.

Although the protection the J&J vaccine offers appears more stable over time than that of Pfizer and Moderna’s, it still produces fewer coronavirus antibodies overall compared to its two competitors.

In response to an FDA panel member who brought up this discrepancy, Penny Heaton, J&J’s global therapeutic area head for vaccines, said booster shots will further increase this stable and consistent protection.

Research released in September showed a J&J booster shot increased protection against moderate to severe COVID-19 from 74% to 94% in the U.S.

Antibody levels rose four to six times higher following a booster shot of the J&J vaccine given two months after the first dose.

When given six months after the first dose, the booster led to a 12-fold increase in antibody levels after about a month, however, this data was based on only 17 patients.

The FDA was originally going to vote on a second question about extending the wait period between first doses and booster shots from two months to six months, but it appears that question was eliminated after many FDA panel members voiced their concerns about applying results from such a small group to millions of people.

A recent CDC study among more than 3,600 coronavirus patients found that a single-dose of the J&J vaccine was 71% effective against COVID-19 hospitalization, which is much lower than the 81% effectiveness the company found in its own real-world evaluation. The study adds to other evidence that suggests a J&J booster dose would increase protection against COVID-19.

The J&J vaccine has been available since Feb. 27 for people ages 18 and older. It’s currently authorized for emergency use as a single-dose shot.

More than 188.3 million people in the U.S. are fully vaccinated against COVID-19 as of Oct. 14, according to a CDC tracker, including more than 15 million who have received the J&J vaccine.

More than 10,000 people have received a booster of the J&J shot as of Oct. 14.

People with weakened immune systems have been allowed to receive a booster of either the Pfizer or Moderna coronavirus vaccines since August.

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