FDA authorizes J&J COVID vaccine after unanimous vote [Updated]

Update, 2/27/2021 7:20pm EST: The US Food and Drug Administration on Saturday night granted emergency use authorization for Johnson & Johnson’s COVID-19 vaccine. The vaccine is the third approved within the US and the primary to require solely a single shot, which might be shipped at fridge temperatures.

“The authorization of this vaccine expands the supply of vaccines, the very best medical prevention technique for COVID-19, to assist us within the combat in opposition to this pandemic, which has claimed over half one million lives within the United States,” Acting FDA Commissioner Janet Woodcock mentioned in an announcement.

The vaccine makes use of a non-replicating adenovirus (Ad26)—a kind of virus that causes widespread colds—to ship the genetic blueprints of the SARS-CoV-2 spike protein to cells. The FDA approved it to be used in individuals aged 18 and older.

“After an intensive evaluation of the information, the FDA’s scientists and physicians have decided that the vaccine meets the FDA’s expectations for security and effectiveness applicable for the authorization of a vaccine for emergency use,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, mentioned. “With at this time’s authorization, we’re including one other vaccine in our medical toolbox to combat this virus. At the identical time, the American individuals might be assured of the FDA’s unwavering dedication to public well being by our complete and rigorous analysis of the information submitted for vaccines to stop COVID-19.”

Original story, 2/26/2021 5:17pm EST: After a day-long assembly Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to suggest issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine.

If the FDA accepts the panel’s suggestion and grants the EUA—which it probably will—the nation could have a 3rd COVID-19 vaccine approved to be used. Earlier this week, FDA scientists launched their evaluation of the vaccine, endorsing authorization. Today’s panel, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) went by the information additional.

“It’s a comparatively straightforward name,” Eric Rubin, a Harvard researcher and voting member of the VRBPAC mentioned after the vote. “[The vaccine] clearly will get approach over the bar and it’s good to have a single-dose vaccine… the demand is so giant [for vaccines], it clearly has a spot.”

Agency watchers anticipate the FDA to maneuver rapidly on the choice, presumably granting the EUA as early as tomorrow, February 27. The FDA moved that quick in granting EUAs for the 2 beforehand approved vaccines, the Moderna and Pfizer/BioNTech mRNA vaccines.

Additionally, an advisory panel for the Centers for Disease Control and Prevention that makes suggestions on vaccine use has scheduled an emergency assembly for this Sunday to debate the vaccine’s use, additional bolstering hypothesis that the federal authorities will transfer rapidly to authorize and roll out the vaccine. If the entire items fall in line, doses of Johnson & Johnson’s COVID-19 vaccine might start delivery out to vaccination websites early subsequent week.

The rollout gained’t be an enormous burst of recent doses instantly, although; it should probably be a sluggish roll. In congressional testimony this week, a Johnson & Johnson government mentioned that the corporate would offer 4 million doses after the EUA, with a complete of 20 million prepared by the top of March and a complete of 100 million by the top of June. Still, with the vaccine solely requiring a single-shot, these 100 million doses equate to 100 million individuals protected.

Efficacy

According to an in depth FDA evaluation of Phase III medical trial knowledge submitted by Johnson & Johnson, the vaccine was 66 p.c efficient at stopping reasonable to extreme COVID-19 at 28 days after vaccination. (Johnson & Johnson outlined reasonable instances to incorporate instances that had two signs, comparable to cough and fever, which might have been labeled as merely “symptomatic” infections in different trials.)

The worldwide trial, which concerned over 44,000 members in varied trial websites, had totally different efficacies somewhere else. In the US, the general efficacy was barely greater, at 72 p.c. But in locations the place variants of concern are extensively circulating, the efficacy fell. It was 64 p.c efficient in South Africa, and 61 p.c efficient in Latin America.

Reassuringly, the efficacy in opposition to extreme and demanding illness was excessive throughout the board, in all of the trial places and throughout age teams. Efficacy in opposition to extreme illness was 85 p.c total 28 days after vaccination. By location, efficacy in opposition to extreme illness within the US was at 86 p.c, 82 p.c in South Africa, and 88 p.c in Brazil. In an additional evaluation, there have been zero hospitalizations amongst vaccinated members and 16 within the placebo group. As of February 5, there have been seven COVID-19-related deaths within the trial, all of which have been within the placebo group.

In addition, Johnson & Johnson has a 30,000-person trial in progress testing whether or not including a booster shot will additional improve efficacy.

Side results

As for uncomfortable side effects, the vaccine has a “favorable security profile,” in line with the FDA. The most typical uncomfortable side effects seen among the many 44,000 or so members have been injection web site ache (49 p.c), headache (39 p.c), fatigue (38 p.c), and myalgia (33 p.c). There have been 15 instances of blood-clotting-related circumstances amongst vaccinated members, in contrast with 10 within the placebo group. There have been additionally six instances of tinnitus (ringing within the ears) among the many vaccinated and nil within the placebo group. It’s unclear if these circumstances have been associated to the vaccine.

While anaphylaxis has been a uncommon however documented incidence with the mRNA vaccines, it seems to be much less of a threat with Johnson & Johnson’s vaccine. There was a single case of a extreme hypersensitivity response two days after vaccination that was thought-about probably associated to the vaccine. But the response was not labeled as anaphylaxis.