Johnson & Johnson single-dose vaccine candidate 'a really big deal,' experts say

Johnson & Johnson has filed an emergency use authorization application with the FDA for their single-dose COVID-19 vaccine.

Health officials are hopeful this version will alleviate logistical and supply-chain concerns presented by the multi-dose versions currently available.

"The strategies for multiple dose, even different counties have different strategies. Do you hold on to the second dose? Do you just assume you'll get another? You have to schedule? People don't show for the second dose. So a single-dose is a really big deal," said Dr. Joseph Eron, the Chief of the Division of Infectious Diseases for UNC's School of Medicine, who also served as a trial investigator for the Moderna trial.

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Through Thursday, just over 905,000 North Carolinians had received the first dose of the vaccine, but just about a quarter of people have gotten the second shot.

Johnson & Johnson says their vaccine is 60% effective at preventing symptomatic disease, 85% effective against severe illness, and 100% effective against hospitalizations and deaths. While the vaccines is less effective at preventing symptomatic disease when compared to the multi-dose Pfizer and Moderna versions (95% and 94%, respectively), for comparison, the CDC reports the flu vaccine is about 60% effective in a good year. The FDA noted they will consider Emergency Use Authorization for any vaccine candidate that is at least 50% effective, a threshold Johnson & Johnson reports to have cleared.

"What Johnson and Johnson is doing is a novel way to get the actual antigen, the part that stimulates the immune system, in to people's bodies. It's a vector. We don't have any widely distributed vaccines that use that mechanism, so we do want the FDA to look pretty carefully," said Dr. Eron.

The FDA is set to hold a hearing on the data on February 26, three weeks from now.

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"The process is getting the data in-house, and having both the clinical and statistical experts go through it and do some of the same calculations that the company does, and try to come up with the same response," said Eron.

This comes as there is concern over how existing vaccines will respond to variant strains, including the B.1.1.7 variant which has been found in North Carolina.

"The faster we get effective vaccines out there, the less opportunity there is for those variants to spread. Fortunately, the B.1.1.7 variant appears to be pretty well covered," said Dr. Eron.

Moderna and AstraZeneca report their vaccines appear to respond effectively against the B.1.1.7 variant.
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