In-Depth: Johnson and Johnson vaccine booster faces 'high stakes' vote

Virus Outbreak J And J Vaccine
Posted at 6:13 PM, Oct 14, 2021
and last updated 2021-10-16 13:13:12-04

SAN DIEGO (KGTV) -- An advisory panel to the Food and Drug Administration will vote Friday on whether to recommend boosters for people who got the Johnson and Johnson COVID-19 vaccine.

The discussion by outside experts to the agency could have major implications for the vaccine’s future use in the United States after a study released this week suggested recipients of the J & J vaccine might be better off getting a booster from a different company.

“It’s shaping up to be a high stakes meeting for Team J &J,” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.

Researchers organized by the National Institutes of Health looked at about 450 people immunized with J & J, Pfizer or Moderna. They divided the volunteers into groups of 50 and gave them one of the three brands as a booster.

The study found J & J recipients who got a J & J booster generated four times as many virus-fighting antibodies. That’s positive, experts said, but it was the only combination researchers tested that failed to meet the threshold of antibody levels thought to correlate with 90 percent effectiveness.

To reach 90 percent effectiveness, the booster would need to increase antibody levels roughly 13-fold.

J & J recipients who got a Pfizer booster easily cleared that bar, making 36 times as many antibodies as they did before the second shot.

However, the study found a Moderna booster was by far the best, with a 76-fold surge in antibody production.

By its nature, this study isn’t as definitive as a clinical trial because antibodies are just one component of the immune system, Dr. Chin-Hong said. The study was also fairly small in size. But the results are sparking a lot of debate within the medical community ahead of Friday’s FDA advisory vote.

“The real question is, is it time to give up on J & J? Should we go to a new vaccine altogether for those J & J recipients?” said Dr. Chin-Hong.

On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee will vote on whether to recommend a second dose for J & J recipients and how many months people should wait to get it. The panel will consider an interval of two to six months.

J & J is pushing for a second dose of its vaccine. Final results from the company’s clinical trial showed protection from the first shot against mild disease waned to just 42 percent with four months. A single dose remains 73 percent effective against severe disease.

The company said a second dose given after two months improved effectiveness against mild disease to 75 percent.

But some experts question whether J & J submitted enough data to justify its request. This week, the FDA said a key lab test used by the company may have skewed some of its findings.

“I do think there are some people that really should get boosters. I don’t think the entire world needs a booster,” said Dr. Christian Ramers of Family Health Centers of San Diego.

Individuals at high risk from underlying conditions or workplace exposure likely need another dose, he said, but young and otherwise healthy people likely do not.

Friday’s FDA panel will be more complicated than the previous hearings for Pfizer and Moderna because of the questions about the company’s data, the timing of doses, and the new study on mixing-and-matching brands, Ramers said.

But he expects the 15 million people who got J & J will get permission to get some kind of second shot soon.