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Johnson & Johnson's Vaccine Gets Unanimous Backing Of FDA Panel, Emergency-Use Authorization Soon To Come

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Johnson & Johnson's Vaccine Gets Unanimous Backing Of FDA Panel, Emergency-Use Authorization Soon To Come

Johnson & Johnson's (NYSE: JNJ) coronavirus vaccine candidate could be given clearance for emergency use today, following unanimous backing by a Food and Drug Administration panel.

What Happened: The FDA plans to rapidly finalize the vaccine and authorize it for emergency use. It is working with other federal agencies to ensure timely vaccine distribution, Acting Commissioner Janet Woodcock said in a statement.

The announcement followed a live-streamed one-day meeting on Friday of the FDA's Vaccines and Related Biological Products Advisory Committee.

This vaccine is a single-dose shot for adults 18 years and older. An independent expert panel, consisting of 22 members, voted unanimously to authorize the vaccine candidate, deeming the benefits of the vaccine outweigh the known risks.

Although committee members expressed apprehensions over lower efficacy in some adults over the age of 60, it was finally decided that this subgroup was too small a population to draw broader conclusions.

"We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible," said Paul Stoffels, chief scientific officer at J&J.

The recommendation was based on evidence provided by the company, including efficacy and safety data from the Phase 3 ENSEMBLE trial, which showed that the vaccine was 66% effective in preventing moderate-to-severe cases of the disease.

Related Link: Why Merck Is Buying Autoimmune Disease Drug Company Pandion For $1.85B

The overall efficacy, however, pales before the 95% efficacy reported by Moderna Inc (NASDAQ: MRNA) and Pfizer Inc. (NYSE: PFE)-BioNTech SE – ADR (NASDAQ: BNTX) for their vaccine candidates.

Moderna and Pfizer-BioNTech received authorizations for their vaccine candidates in December.

Unlike the messenger RNA vaccines of Moderna and Pfizer-BioNTech, J&J's vaccine candidate uses a single-dose regimen and is an experimental viral vector vaccine that uses a weakened form of adenovirus to transport genetic material to trigger immune response.

J&J's vaccine candidate can remain stable for two years at -20 degrees Celsius, at least three months of which can be at temperatures of 2-8 degrees Celsius. The vaccines from Moderna and Pfizer, on the other hand, require cold-chain logistics to stay effective.

What's Next: After emergency use authorization, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will provide a recommendation on the use and roll-out of J&J's vaccine.

The company said it is prepared to supply its vaccine immediately upon authorization and expects to deliver enough single-dose vaccines by the end of March to vaccinate more than 20 million people in the U.S. The company plans to deliver 100 million single-dose vaccines in the U.S. during the first half of 2021.

J&J also has an application pending before European regulators for obtaining conditional marketing authorization in the region. The World Health Organization is reviewing an emergency use listing for the vaccine.

Related Link: The Daily Biotech Pulse: Adcom Test Awaits J&J's COVID-19 Vaccine, Lilly To Supply Additional Antibody Therapy Doses To US, Regulatory Setback For Tricida

 

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