An independent committee of vaccine experts just gave a unanimous recommendation to the Food and Drug Administration that they give full authorization for Johnson & Johnson's single-shot COVID-19 vaccine for people 18 years and older, according to a new document posted on the FDA's official website.
With this news, the latest vaccine against the virus is on track for authorization as soon as Saturday.
Johnson & Johnson COVID-19 vaccine approved by independent FDA committee
Today, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gathered to discuss data on the latest clinical trials of Johnson & Johnson's single-shot COVID-19 vaccine, which underwent FDA evaluation in the last several weeks.
The FDA's initial analysis suggested the vaccine was safe, with an 85% effectiveness rating against serious cases of COVID-19 illness around the world. As of writing, no one who received the Johnson & Johnson vaccine has been hospitalized or died from the virus.
Once more moderate cases were added to the evaluation, the company's vaccine effectiveness dropped to 72% in the U.S., and 64% in South Africa — where a coronavirus variant capable of evading immune protection is rapidly spreading. But even for the moderate cases of COVID-19, the FDA trial was a net positive.
People who became ill with COVID-19 despite a vaccination with Johnson & Johnson's vaccine had fewer symptoms than those who contracted the coronavirus and developed COVID-19 without receiving the vaccine, according to a Johnson & Johnson analysis.
Initial data regarding the vaccine suggests it is less effective in older adults or people with chronic health conditions — like HIV — but FDA officials said there was less data for these subset groups of trial participants.
Johnson & Johnson might try double-dose if effectiveness is enhanced
Once more cases were added to the FDA's analysis, differences between the above at-risk groups and everyone else in the trial reduced in scope and gravity, said Rachel Zhang, an FDA medical officer in a report from The Verge, during a presentation on the agency's data on Friday.
Johnson & Johnson's vaccine is single-shot, which means only one dose is needed to protect people against the ravages of COVID-19 illness. This makes it easier to distribute than Pfizer/BioNTech and Moderna's vaccines, both of which require two shots to work.
"It simplifies the process. People only have to make one appointment for their complete vaccination," said the Director of the Mayo Clinic's Vaccine Research Group during the company's presentation, according to The Verge. "A one dose vaccination decreases the burden on the health care system and health care providers."
Johnson & Johnson is also executing clinical trials to learn whether the two doses of their vaccine might be better than a single shot. Paul Offit — a member of VRBPAC and vaccine researcher at the Children's Hospital of Philadelphia — suggested it might be tricky to switch the vaccine's architecture for a two-dose procedure if it turns out to have a greater effect.
Vaccine may still be susceptible to 'the devil' California variant
"You can see where that would be confusing to people," said Offit during the meeting.
"It seems like a big logistical problem," said another VRBPAC Member Eric Rubin, who is also an immunologist at the Harvard T.H. Chan School of Public Health, The Verge reports. Johnson & Johnson aims to run more trials on its vaccine to test the effectiveness on children, adolescents, and pregnant women.
As of writing, Johnson & Johnson stands poised to deliver 4 million doses of its vaccine, once it receives full FDA authorization. While this is incredible news, it remains to be seen whether the company's single-shot — or a potential double-shot — will prove effective against the California strain of the COVID-19 illness that officials have called "the devil."
This was a breaking story and was regularly updated as new information became available.