Pharmaceutical large Johnson & Johnson announced Tuesday that it has submitted new knowledge to the Food and Drug Administration within the hopes of securing emergency approval of its COVID-19 vaccine booster shot for folks 18 and older.
The firm reiterated knowledge unveiled final month that confirmed a second dose of Johnson & Johnson’s one-shot vaccine given about two months after the primary elevated its effectiveness to 94 % in opposition to symptomatic an infection.
The two-shot routine additionally offered one hundred pc safety in opposition to important COVID-19 no less than 14 days after the booster shot, based on the corporate.
“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” mentioned Dr. Mathai Mammen, world head of analysis and improvement at J&J’s vaccine improvement 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 assembly of its skilled advisory committee to debate whether or not to grant an emergency use authorization for J&J’s booster shot.
J&J is the third firm to hunt emergency authorization of its booster shot within the US.
Last month, the company granted an emergency authorization of Pfizer’s booster shot for these 65 and older, these with underlying circumstances and sure frontline employees.
The third shot is out there to these folks no less than six months after completion of the preliminary two-shot course, based mostly on the FDA’s advice.
The Centers for Disease Control and Prevention then beneficial the third shot for a similar teams in a controversial determination that pitted CDC director Dr. Rochelle Walensky in opposition to exterior advisors to the CDC who thought booster photographs weren’t vital for frontline employees.
Shares of J&J have been up about 0.5 % in premarket buying and selling on the information. The inventory was final seen buying and selling at about $160 per share, giving the New Brunswick, New Jersey-based firm a market cap of about $419 billion.