Boosters are 3 for 3: FDA rounds out week with J&J endorsement
Regulators paved the way Friday for those who received one-dose Johnson and Johnson vaccine to up waning immunity
First came Pfizer, then Moderna. Finally, it was Johnson and Johnson’s time before the FDA commission tasked with weighing in on tweaking the vaccines’ emergency use authorizations.
The FDA’s 19-member Vaccines and Related Biological Products Advisory Committee voted unanimously Friday to recommend that everyone who received the COVID-19 vaccine developed by Johnson and Johnson receive a second dose at least two months after the first jab.
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said Dr. James Hildreth Sr., committee member and president of Meharry Medical College.
Unlike the Pfizer and Moderna vaccines whose boosters are intended for at-risk individuals, the panel recommended a second dose for any J&J recipient over the age 18.
Janssen Biotech, a company of Johnson & Johnson that developed the vaccine, requested on Oct. 4, 2021, to alter the emergency use authorization to include a second shot to boost immunity to the virus.
According to the company’s briefing documents issued ahead of the meeting, J&J’s one-shot dose prevented hospitalization and death from COVID-19 for at least six months in adults who received the jab. But the company observed the J&J vaccine’s protection against instances of COVID-19 where symptoms are present waned over time.
Janssen’s briefing documents said that while the one dose was good earlier in the pandemic, the number of unvaccinated people in the United States today leaves vaccinated people at risk for new COVID-19 variants.
“Based on recent data, administration of a booster dose resulted in increased protection against symptomatic COVID-19, increased strength and breadth of immune responses against variants and increase protection against severe/critical COVID-19,” Janssen Biotech’s briefing states.
Presenting before the committee, Janssen’s Penny Heaton said the J&J vaccine’s single dose gave an individual about 74% efficacy against COVID-19, and a second dose conferred about 94% efficacy if the second dose was given about six months after the first.
The company told the committee adverse reactions to the second dose seemed less common in recipients than with the first doses.
To arrive at its conclusions, Janssen gave about 9,000 people a second dose. But its study looking at how the second vaccine dose performed after administering it six months after the first included only 17 participants.
“We want optional protection against COVID and we know that a booster will do that,” Heaton said.
Dr. Johan Van Hoof, who led the company’s effort to develop the vaccine, said the booster was “to stay ahead of the game.”
The move comes after the FDA committee the day before unanimously endorsed a proposal by Moderna to give a half-dose of its vaccine to vulnerable adults. Pfizer received authorization to distribute booster shots to vulnerable adults in late September.
While 15 million Americans received the Johnson and Johnson COVID-19 vaccine, the shot faced a rocky rollout earlier in the pandemic. In April, the FDA and CDC paused the rollout of the J&J shot for 10 days because of concerns over six instances of women who got the shot experiencing a rare blood clot. The government resumed the distribution after a warning was added to the vaccines’ fact sheet.
Around that time, a facility manufacturing the Johnson and Johnson vaccine made an error and was forced to throw out millions of doses.
Janssen Biotech’s stop at the FDA committee was one of four steps it needs before its booster shots can become widely distributed in arms. The FDA will issue a determination after hearing the recommendation from its committee. Afterward, the question heads over to an independent panel at the Centers for Disease Control and Prevention for its input so the CDC director can make her determination.
On Friday, the FDA committee held its meeting remotely over teleconferencing software, which it broadcast to YouTube.
While the committee deliberated, some members had concerns whether a second J&J shot was warranted. Committee member Dr. Michael Kurilla said the data showed efficacy of the J&J vaccine seems to be holding fast and he questioned the immediate need for a booster. The mRNA vaccines à la Pfizer and Moderna have high decay rates, he noted.
But Dr. Arnold Monto, chair of the FDA committee, said there was “some urgency here to do something” given the lower efficacy of the Johnson and Johnson vaccine compared to other vaccines.