FDA panel recommends J&J COVID vaccine for emergency use

Food and Drug Administration (FDA) vaccine advisors today recommended that the agency grant emergency use authorization (EUA) for Johnson & Johnson's COVID-19 vaccine, which brings the nation one step closer to having a third COVID-19 vaccine.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was asked to consider if the benefits outweigh the risks in people ages 18 and older. The measure passed unanimously, with 22 affirmative votes.

After the vote, Archana Chatterjee, MD, PhD, a VRBPAC member who is a pediatric infectious disease specialist and dean of Chicago Medical School, said despite concerns raised during today's discussion, it's good to keep in mind that the world is still in a pandemic. "This vaccine will help meet the needs at the moment."

Members also said the nation is in a race against mutated viruses and stopping the spread of the virus. They also said the Johnson & Johnson vaccine clears well above the bar as a good vaccine and that none are recommended as better than the others. They also said they hoped for more data, which will help guide clinical use.

FDA nod could come tomorrow

Now, it's up to FDA officials to make a final decision, which could come as soon as tomorrow. The FDA often follows the recommendations of VRBPAC, made up of outside experts.

Earlier this week, a Johnson & Johnson official told US lawmakers at a House hearing that the company expects to deliver 100 million doses during the first half of the year, with an initial 20 million coming in March. White House officials have said about 2 million doses of the vaccine will be available to allocate to states next week, with more for pharmacies and community health centers.

The vaccine, once approved, would be the first adenovirus-based COVID-19 vaccine in the United States and the first given as a single dose. It can be shipped and stored under normal refrigeration temperature, making it a good option for a broader range of vaccination settings, including doctor's offices and in deployment to developing countries.

Large data pool from multiple nations

Trials of the Johnson & Johnson vaccine are the largest to date, enrolling more than 43,000 people across the United States, Latin America, and South Africa.

In the US arm of the trial, the vaccine was 72% effective against moderate to severe disease and 85% effective against severe disease. Combined with the trials from other countries, the vaccine was 66.1% effective, beginning at 28 days after immunization. Phase 3 trials found 66% efficacy in Latin America participants and 57% in South Africa, where the B1351 variant was the dominant strain.

Like the other two FDA-approved vaccines from Pfizer/BioNTech and Moderna, the Johnson & Johnson vaccine provided 100% protection against death and hospitalization.

Regarding safety, no life-threatening allergic reactions occurred in the clinical trials, but a company official said today that one participant in South Africa experienced anaphylaxis after vaccination. And an FDA analysis released this week ahead of the VRBPAC meeting said side effects were milder than for the Pfizer and Moderna COVID-19 vaccines.

Company officials said they are studying a two-dose regimen to assess if a booster dose is more effective, and some meeting participants worried about how to navigate regulatory issues and explain any possible change to the public. The company said today that it will soon begin recruiting for a study of the vaccine in about 3,000 children ages 12 to 18, which will also span different countries.

During today's deliberations, the company also fielded questions about lower efficacy (42%) reported in people over 60 with underlying health conditions. Johnson & Johnson officials said the finding is based on sparse data and that ongoing study will likely show a clearer picture.

Next steps

Following the FDA's final decision on its advisory group recommendation, on Feb 28, the Centers for Disease Control and Prevention (CDC) advisory group will meet to consider recommending the Johnson & Johnson vaccine.

If the group—known as the Advisory Committee on Immunization Practices (ACIP)—green-lights the vaccine at its virtual meeting and the CDC accepts the recommendation, the company can begin distributing the vaccine.

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