J&J seeks FDA's approval for Covid-19 vaccine booster shot in adults

Johnson & Johnson asked the U.S. Food and Drug Administration to authorize a second dose of its Covid-19 vaccine for adults after a study showed it provided strong protection against infection.

The submission includes results from a late-stage clinical trial that found a booster dose of its one-shot vaccine given 56 days after the first inoculation provided 94% protection against moderate to severe disease in the U.S., the company said in a statement on Tuesday. 

Last week, the FDA said it had scheduled a meeting of its outside scientific advisers to discuss potential boosters for the J&J and Moderna Inc. vaccines on Oct. 14-15.

If authorized, J&J’s booster could give millions more Americans additional protection against the coronavirus. On Sept. 24, some recipients of the Pfizer Inc.-BioNTech SE vaccine became eligible for a supplemental dose, including those 65 and up. 

J&J shares rose 0.6% in premarket U.S. trading.

Some experts have questioned the need for the broad use of boosters, while the World Health Organization has called for a moratorium on them this year, until more people outside of rich countries get protection. The Biden administration has urged boosters be given more widely to help tamp down the current delta variant-fueled outbreak of illness in the U.S.

Read More: Biden’s Booster Crusade Limps to Finish Line, Dogged by Uncertainty

The Centers for Disease Control and Prevention expects recipients of the Moderna and J&J vaccines, like those who received the Pfizer shot, will likely also need a booster. The FDA must still evaluate the study data and clear the boosters before people can get them.

J&J said in September that a second dose of its vaccine provided 100% protection against severe disease when given two months after the first inoculation.

The late-stage clinical trial also found that the booster was 94% effective at preventing symptomatic Covid infections in the U.S., and 75% effective overall when it was given 56 days after the initial dose. It also triggered a strong increase in protective antibodies.

J&J’s Reach

Once expected to be the heavyweight of the U.S. immunization campaign, J&J’s adenovirus-based vaccine has had a limited reach.

Only about 15 million people in the U.S. have received the single-shot vaccine, according the CDC. By comparison, some 171 million people have had the two-shot messenger RNA regimens developed by Moderna and Pfizer-BioNTech.

J&J has also grappled with production setbacks. In April, U.S. regulators told contract manufacturer Emergent BioSolutions Inc. to halt production of J&J’s shot after staff accidentally conflated its ingredients with components of AstraZeneca Plc’s Covid-19 shot.

Now, the picture is improving. In July, the FDA greenlit Emergent to resume production, and the agency has inspected and cleared many batches that had been kept from distribution by the earlier halt.

Toward the end of the summer, J&J fulfilled its first supply agreement with the U.S. government for Covid-19 vaccines, shipping all 100 million contracted-for doses following major delays in production, according to a person familiar with the matter.

Some of those doses have been donated outside the U.S., while others linger unused in U.S.-based hospitals, care providers and vaccine pop-ups.

If and when the J&J booster campaign starts, the U.S. government will have to tap into that supply. Bloomberg reported last month that the Biden administration quietly shelved its plan to buy another 100 million doses of the vaccine.