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

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Posted at 6:30 AM, Oct 05, 2021

NEW BRUNSWICK, N.J. — Johnson & Johnson (J&J) announced Tuesday that it has submitted data to the Food and Drug Administration (FDA) to support the use of a booster shot of its COVID-19 vaccine in Americans 18 years of age and older.

Many in the U.S. have received an initial dose of the J&J vaccine since it was granted emergency use authorization by the FDA in February of this year.

Now, researchers at J&J say studies have shown that a booster of their COVID-19 vaccine increases levels of protection for those who have received their shot to 94%.

Specifically, J&J says a study found a booster of its vaccine given 56 days after the primary dose provided 94% protection against symptomatic COVID-19 in the U.S. and 100% protection against severe or critical COVID-19 at least 14 days post-booster vaccination.

J&J is also including data in its FDA submission that show when a booster of its vaccine was given six months after the first shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.

“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, J&J. “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.”

The FDA has already amended its emergency use authorization for Pfizer to allow for a single booster shot of its COVID-19 vaccine. Right now, it’s the only booster shot available in the U.S.

According to the FDA, a single booster dose of Pfizer's booster shot can be administered at least six months after completion of the first two doses for people 65 years of age and older, those 18 to 64 who are at high risk of severe COVID-19, and those 18 to 64 whose occupational exposure to the coronavirus puts them at high risk of serious complications from COVID-19.

However, along with J&J, Moderna has also submitted data to the FDA for its COVID-19 vaccine booster. An advisory committee to the FDA is set to hold meetings to consider the Moderna boosters in mid-October.

J&J says it also plans to submit its data to other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.