The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee will meet Friday to review and vote on whether or not to recommend Johnson & Johnson's COVID-19 vaccine, signaling that a third inoculation against the deadly coronavirus could be on the horizon.
If the panel votes to recommend the vaccine, it could receive Emergency Use Authorization (EUA) as soon as the next day.
The vote, which is set for late Friday afternoon, will be preceded by hours of debate and presentations from Johnson & Johnson and government scientists.
The other two COVID-19 vaccines granted EUA from the FDA – from Pfizer-BioNTech and Moderna – were approved one day after their advisory committee meetings.
Johnson & Johnson applied to the FDA for authorization earlier this month.
The company announced findings in January that showed that its single-shot vaccine was 66% effective overall at preventing moderate to severe illness, and much more protective – 85% – against the most serious symptoms.
There was some geographic variation. The vaccine worked better in the United States – 72% effective against moderate to severe COVID-19 – compared to 57% in South Africa, where it was up against an easier-to-spread mutated virus.
"Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” Alex Gorsky, the company's Chairman and Chief Executive Officer said in a statement. "We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere."
The company expects to supply 100 million doses to the U.S. by June, and expects to have some ready to ship as soon as authorities give the green light.
J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along.
Rival AstraZeneca makes a similar cold virus vaccine that requires two doses. Both the AstraZeneca and J&J vaccines can be stored in a refrigerator, making them easier to ship and to use in developing countries than the frozen kind made by Pfizer and Moderna.
It’s not clear exactly how well the AstraZeneca version, being used in Britain and several other countries, works. Tests in Britain, South Africa and Brazil suggested two doses are about 70% effective although there are questions about how much protection older adults get. An ongoing U.S. study may provide more information.
J&J said its vaccine works consistently in a broad range of people: A third of participants were over age 60, and more than 40% had other illnesses putting them at risk of severe COVID-19, including obesity, diabetes and HIV.
The company said the vaccine is safe, with reactions similar to other COVID-19 shots such as fever that occur when the immune system is revved up.
While it released few details, the company said there were no serious allergic reactions. But occasionally other COVID-19 vaccines trigger such reactions, which can be reversed if promptly treated – and authorities have warned people to be on the lookout regardless of which type of vaccine is used.
J&J had hedged its bets with a study of a two-dose version of its vaccine, which is still underway.
The Associated Press contributed to this report.
NOTE: An earlier version of this story incorrectly said this meeting would take place Thursday. The story has since been corrected.