Pharmaceutical giant Johnson & Johnson announced Tuesday that it has asked the Food and Drug Administration to grant emergency approval of its COVID-19 vaccine booster shot for people 18 and older.
The company reiterated data unveiled last month that showed a second dose of Johnson & Johnson’s one-shot vaccine given about two months after the first increased its effectiveness to 94 percent against symptomatic infection.
The two-shot regimen also provided 100 percent protection against critical COVID-19 at least 14 days after the booster shot, according to the company.
“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, global head of research and development at J&J’s vaccine development arm.
“At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
Last week, the FDA scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant an emergency use authorization for J&J’s booster shot.
J&J is the third company to seek emergency authorization of its booster shot in the US.
Moderna applied for emergency-use authorization for its COVID-19 vaccine booster shot last month, but the FDA has not yet responded. An expert panel of the FDA will meet Oct. 14 to deliberate on the merits of Moderna’s booster.
Last month, the agency granted an emergency authorization of Pfizer’s booster shot for those 65 and older, those with underlying conditions and certain front-line workers.
The third shot is available to those people at least six months after completion of the initial two-shot course, based on the FDA’s recommendation.
The Centers for Disease Control and Prevention then recommended the third shot for the same groups in a controversial decision that pitted CDC director Dr. Rochelle Walensky against external advisers to the CDC who thought booster shots weren’t necessary for front-line workers.
Shares of J&J were up about 0.5 percent in premarket trading on the news. The stock was last seen trading at about $160 per share, giving the New Brunswick, New Jersey-based company a market cap of about $419 billion.