FDA Panel Clears J&J COVID-19 Vaccine For Emergency Use

By Britain Eakin
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Law360 (February 26, 2021, 5:11 PM EST) -- A U.S. Food and Drug Administration panel approved Johnson & Johnson's request for emergency use authorization of its COVID-19 vaccine Friday, clearing the way for a third vaccine that J&J said is safe and offers strong protection against severe disease, hospitalization and death.

The panel voted to approve emergency use unanimously 22-0, with no abstentions, the last step before the FDA decides whether to issue an emergency use authorization, or EUA, which is a quicker process than seeking full FDA approval. While the FDA doesn't have to follow the committee's advice, it often does and is expected to approve the EUA in this case.

FDA acting commissioner Janet Woodcock and Peter Marks, director for the agency's Center for Biologics Evaluation and Research, indicated in a statement that would be the case, saying the FDA plans to move swiftly in the wake of the advisory committee's vote.

"Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization," the statement said. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution."

J&J said the vaccine has an overall efficacy rate of 72% in the U.S., and is 86% effective at preventing severe cases. The company also said the data shows the vaccine offers complete protection against hospitalization and death.

Ofer Levy, director of the precision vaccines program at Boston's Children Hospital and one of the advisory committee's temporary voting members, said after Friday's vote that the committee was impressed through and through by the vaccine.

"In addition to the safety and efficacy that we were impressed with as a committee is the storage at 4 degrees, which is very practical for rural areas in the United States and around the world," he said.

Gregory A. Poland, director of the Mayo Clinic's vaccine research group, said during the Vaccines and Related Biological Products meeting that those findings could go a long way toward alleviating the strain on the U.S. health care system.

"The prevention of hospitalizations and deaths was a particularly important finding when you consider the burden this disease has placed on hospitals and health care workers," he said.

Poland also noted that trial participants who got the vaccine and still got infected had milder cases, which he called "another welcome benefit, both for individuals and the health care system."

The vaccinologist also drew attention to the vaccine's efficacy against emerging and more transmissible variants of the virus, like the one that appeared in South Africa. According to J&J's data, the vaccine was 82% effective at preventing severe cases in South Africa.

Poland said it will be critical to stay ahead of the variants to get the pandemic under control.

The vaccine, named JNJ-78436735, was developed by J&J's pharmaceutical arm, Janssen Biotech Inc. J&J said it expects to supply 100 million doses to the U.S. during the first half of 2021 if the FDA grants emergency use.

J&J submitted its application for emergency use authorization on Feb. 4. The submission included data from a Phase 3 clinical study involving about 43,800 participants, of which 468 became symptomatic. There were no significant safety concerns with the vaccine, though a small number of individuals developed fevers, J&J said.

The vaccine's effectiveness varied from country to country but was shown to be 66% effective globally 28 days after vaccination, and 85% effective at preventing severe disease. During the FDA advisory committee meeting Friday, Macaya Douoguih, the head of clinical development and medical affairs in Janssen's vaccine division, said vaccine efficacy kicks in seven days after vaccination, and then grows.

On day 14, the data shows that the J&J vaccine reached a 67% rate of efficacy globally, and 74% in the U.S. study, Douoguih said.

On Dec. 10, the FDA gave its first stamp of approval to a COVID-19 vaccine when it signed off on an emergency use authorization request from Pfizer and its German partner BioNTech. The first doses of that vaccine were administered to front-line health care workers in the U.S. in later that month. The Pfizer-BioNTech two-dose vaccine is about 95% effective.

Moderna also filed its emergency authorization request in late November. The FDA approved its vaccine, which is 94% effective at preventing infection among individuals 18 and older, in mid-December.

While the Pfizer-BioNTech and Moderna vaccines are more effective, the J&J vaccine has some logistical advantages, including a two-year shelf life when frozen. It can also be stored for three months at normal refrigerated temperatures, while the Pfizer and Moderna vaccines must be stored in freezing temperatures.

But questions remain about the efficacy of the J&J vaccine for certain populations. While efficacy was consistent among Black, Latino and white vaccine trial participants, the data shows it was only about 42% effective for people over 60 with underlying conditions like diabetes, HIV or high blood pressure.

There is also a dearth of data about efficacy of the J&J vaccine in those 75 years and older. And the vaccine hasn't been tested on children or teens under 18, and so won't be approved for that age group.

--Additional reporting by Hailey Konnath. Editing by Adam LoBelia.

Update: This story has been updated with a comment from the FDA.

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