J&J asks FDA to authorize its COVID-19 vaccine booster shots

NEW BRUNSWICK, N.J. — Johnson & Johnson (J&J) announced Tuesday that it has submitted information to the Food and Drug Administration (FDA) to enactment the usage of a booster changeable of its COVID-19 vaccine successful Americans 18 years of property and older.

Many successful the U.S. person received an archetypal dose of the J&J vaccine since it was granted exigency usage authorization by the FDA successful February of this year.

Now, researchers astatine J&J accidental studies person shown that a booster of their COVID-19 vaccine increases levels of extortion for those who person received their changeable to 94%.

Specifically, J&J says a survey recovered a booster of its vaccine fixed 56 days aft the superior dose provided 94% extortion against symptomatic COVID-19 successful the U.S. and 100% extortion against terrible oregon captious COVID-19 astatine slightest 14 days post-booster vaccination.

J&J is besides including information successful its FDA submission that amusement erstwhile a booster of its vaccine was fixed six months aft the archetypal shot, antibody levels accrued nine-fold 1 week aft the booster and continued to ascent to 12-fold higher 4 weeks aft the booster.

“We look guardant to our discussions with the FDA and different wellness authorities to enactment their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, J&J. “At the aforesaid time, we proceed to admit that a single-shot COVID-19 vaccine that provides beardown and long-lasting extortion remains a important constituent to vaccinating the planetary population.”

The FDA has already amended its exigency usage authorization for Pfizer to let for a azygous booster changeable of its COVID-19 vaccine. Right now, it’s the lone booster changeable disposable successful the U.S.

According to the FDA, a azygous booster dose of Pfizer's booster changeable tin beryllium administered astatine slightest six months aft completion of the archetypal 2 doses for radical 65 years of property and older, those 18 to 64 who are astatine precocious hazard of terrible COVID-19, and those 18 to 64 whose occupational vulnerability to the coronavirus puts them astatine precocious hazard of superior complications from COVID-19.

However, on with J&J, Moderna has besides submitted information to the FDA for its COVID-19 vaccine booster. An advisory committee to the FDA is acceptable to clasp meetings to see the Moderna boosters successful mid-October.

J&J says it besides plans to taxable its information to different regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) worldwide to pass decision-making connected section vaccine medication strategies, arsenic needed.