Johnson & Johnson requests FDA authorization for its one-dose COVID-19 vaccine

Johnson & Johnson submitted paperwork Thursday requesting that the U.S. Food and Drug Administration authorize its COVID-19 vaccine for use in adults.

The FDA announced later in the evening that its advisory committee will meet Feb. 26 to discuss the application. The agency is expected to authorize the vaccine within a few days of that meeting, making it the third available to the American public.

J&J announced last week that its vaccine was 72% effective in a U.S. trial, though it was less effective among people in Latin America and South Africa, bringing overall effectiveness down to 66%.

That compares to findings last year that vaccines from Pfizer-BioNTech and Moderna that their vaccines would be more than 94% effective.

Federal officials have said, however, that the trials are not directly comparable because they were conducted at different points in the COVID-19 pandemic.

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It's possible J&J's vaccine would have shown equal effectiveness if its trial had been conducted last summer and fall as the other two were. Now, there are multiple different variants of the virus that causes COVID-19, which might weaken the vaccine's effectiveness.

Still, NIH director Dr. Francis Collins and America's top infectious disease expert Dr. Anthony Fauci, said last week that the J&J vaccine would provide a profound benefit to the fight against the pandemic.

The J&J vaccine is meant to be delivered as a single dose, though the company is running a separate trial to determine if a second dose is worthwhile.

The vaccine can also be stored at refrigerator temperatures, so it will be easier to distribute than the Pfizer-BioNTech and Moderna vaccines, both of which must be kept frozen much of the time.

All the vaccines appear to protect against severe disease and prevent deaths from COVID-19.

"Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Dr. Paul Stoffels, J&J's chief scientific officer said in a prepared statement.

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The company expects to have product available upon authorization. "With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," Stoffels said.

Before authorization, an FDA advisory committee must review the vaccine's data and application in a public hearing that must be announced two weeks ahead of time. That hearing has not been scheduled.

Last year, the federal government spent $1 billion to pre-purchase 100 million doses of J&J vaccine, in addition to nearly $500 million to help develop the vaccine. The government also holds an option to purchase enough doses to vaccine 300 million more people.

Because the J&J vaccine requires only one shot instead of the two required of the other two authorized vaccines, people will be considered protected within two weeks of receiving their injection.

It's not clear whether people will be able to choose which vaccine they receive, or whether different vaccines will be prioritized to different groups.

Some have suggested that it may make sense to continue vaccinating older, more vulnerable people with the Pfizer-BioNTech and Moderna vaccines that showed 94% effectiveness, reserving the J&J vaccine for people at lower risk from COVID-19.

An advisory committee to the Centers for Disease Control and Prevention would make any such recommendation for use before the latest vaccine is authorized.

There are two more candidate vaccines that could be available in the coming months.

One from AstraZeneca and Oxford University has completed a large trial in the United States and is expected to have effectiveness data available later this monthor early next, with authorization likely next month. In earlier trials in other countries, effectiveness data was muddied by dosing differences, but it appeared to be about 60% effective overall.

Gaithersburg, Maryland-based biotech company Novavax is currently recruiting for a large-scale trial in the United States. As of last week, it had recruited 13,000 people out of a desired 30,000. 

This vaccine was shown to be 90% effective in a trial in the U.K., though just 50% effective in South Africa, where a variant has taken hold, and where high rates of people immunocompromised with HIV also reduced effectiveness.

Both the AstraZeneca-Oxford vaccine and the one from Novavax are to be given in two doses and both can be stored in refrigerators, making them relatively easy to distribute.

Contact Karen Weintraub at kweintraub@usatoday.com.

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