FDA finds one-dose J&J COVID-19 vaccine meets criteria as safe and effective

Detailed information on a Johnson & Johnson candidate vaccine for COVID-19 raises no safety concerns, according to a report released early Wednesda.

A Food and Drug Administration advisory committee is holding an all-day meeting Friday to review the data and is likely to give the vaccine a thumbs up, likely leading to an FDA authorization for the vaccine within the next few days.

The J&J vaccine differs from the two already authorized, because only one shot is recommended, instead of two.

The company also is studying a two-dose regimen, which might prove more effective or more durable, in which case people might be encouraged to get a booster shot at some point.

The FDA advisory committee, called the Vaccines and Related Biological Products Advisory Committee or VRBPAC, is expected to sign off on the vaccine because it seems to have met all the criteria for authorization the FDA established last year.

Like the Moderna and Pfizer-BioNTech vaccines, the one from J&J held a large clinical trial showing its safety and effectiveness, and the company has proven it can manufacture the vaccine in a safe and consistent manner.

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Once the committee signs off on the vaccine, it will be up to the acting FDA commissioner to authorize it, which could happen within just a few days.

The vaccine already is being used in South Africa and the company has applied to the European Union and the World Health Organization for authorization.

J&J has agreed to provide 100 million doses of its vaccine in the United States by June, including 20 million by the end of March. Those doses will add to the 300 million doses Pfizer-BioNTech and Moderna each have promised to deliver to the U.S. government by the end of July.

Dr. Victor Peralta, left, examines Sundar Surujmohan's vaccination card before giving him his second dose of COVID-19 vaccine in New York City on Feb. 5.

In a press release last month, J&J said its vaccine was 72% effective in a trial in the United States, with all ethnic, racial and age groups benefitting about the same.

Trials of the vaccine in other countries have shown less effectiveness – 66% in Latin America and 57% in South Africa, 28 days after the shots – likely because of variants of the virus circulating in those countries.

The same variants are also circulating in the U.S., but not yet in very high numbers, so the vaccine is expected to be useful here, particularly because it only requires one dose.

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Although the J&J vaccine appears less effective than ones from Pfizer-BioNTech and Moderna, it’s hard to make direct comparisons, experts say, because those trials were conducted months earlier, at a different point in the pandemic and when there were fewer known variants.

The J&J vaccine was shown to be 85% effective in preventing severe disease across all regions studied 28 days after the shot and proved more effective over time, with no cases of severe disease reported after day 49. The company defined severe disease as respiratory failure, shock, organ failure, or the need for treatment in a hospital intensive care unit.

The trial did not include children or pregnant women.

In the trial of nearly 44,000 adults, about 9% ran a low fever after the shot, but overall, more serious events were reported among those who had received a placebo than those who got the active vaccine. There were no cases of severe allergic reactions.

In terms of demographics, 34% of participants were over 60 and 55% were male. Of the nearly 20,000 participants in the U.S., 74% were white, 15% Hispanic, 13% Black, 6% Asian and 1% were Native American.

More than 40% of the trial participants globally had medical conditions putting them at higher risk for severe COVID-19, including obesity, type 2 diabetes, hypertension or HIV.

The J&J vaccine can be stored in a refrigerator for three months and in a freezer for up to two years, making it relatively easy to distribute through typical medical supply systems.

The FDA is awarding COVID-19 vaccines emergency use authorizations rather than full approvals.

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Although all the testing to date has been comparable to tests required for full approval, the vaccines have not been required to show longer-term data, which would delay their distribution during the pandemic. All the companies are expected to eventually apply for full approval.

Two more companies are likely to request authorization for their vaccines in the next few months. AstraZeneca, working with Oxford University, developed a vaccine that finished enrolling volunteers in its large-scale trial in January, and Novavax announced last week that it had completed enrollment.

Both companies must wait to apply for authorization until at least half their participants are eight weeks out from their second shot, and until enough participants in both placebo and active vaccine groups have come down with symptomatic COVID-19 to determine their vaccine’s effectiveness.

The AstraZeneca-Oxford vaccine already has been authorized for use by the World Health Organization. South Africa has delayed using the vaccine until it can be tested further, because an earlier trial suggested it was not very effective against the dominant variant in that country.

Contact Karen Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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