The FDA vaccine safety panel recommended today the agency authorize the third COVID-19 vaccine. If the agency accepts that recommendation as expected, the single-shot immunization would add millions of more doses to the vaccine supply against the COVID-19 pandemic.
The vaccine was developed by Janssen Pharmaceuticals, an arm of Johnson & Johnson. Studies showed it reduced moderate to severe COVID-19 diagnoses by about 66% among vaccinated people a month later, according to clinical trial data reviewed by the panel and FDA scientists. The J&J vaccine was proved to be 85.4% effective in reducing severe or deadly cases across all coronavirus variants, including the more transmissible ones first identified in Brazil and South Africa.
The unanimous vote reflects the confidence that vaccine experts now have in the safety of such shots overall, after more than 50 million doses have been administered in the US, said panel member Patrick Moore of the University of Pittsburgh Cancer Institute.
“It’s a relatively easy call — this gets well over the bar,” panel member Eric Rubin of Harvard Medical School said after the 22–0 vote. Votes from the panel of outside vaccine safety experts weigh heavily in FDA decision-making, and its positive recommendations shortly preceded the distribution of the two COVID-19 vaccines that have already been authorized.
“A single dose application offers the opportunity to vaccinate a population faster,” said Janssen’s Johan Van Hoof, presenting the J&J vaccine’s experimental results during the meeting.
The one-dose vaccine offers a more flexible alternative to the two previously authorized mRNA vaccines made by Pfizer and Moderna by enabling mass vaccination with its single dose.
According to the coordinator for the White House’s COVID-19 response team, Jeff Zientss, 3 million to 4 million doses of the one-shot vaccine would be distributed next week if the FDA authorizes it. The company says it will deliver 20 million doses to the US by the end of March, and it is obligated to provide 100 million doses by the end of June.