Johnson & Johnson Seeks FDA Approval for Booster Shots for Adults

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Posted: Oct 07, 2021 4:45 PM
Johnson & Johnson Seeks FDA Approval for Booster Shots for Adults

Source: AP Photo/Matt Rourke

Johnson & Johnson reportedly filed a request with the Food and Drug Administration (FDA) to authorize booster shots for people 18 and older who’ve already received the company’s one-dose Wuhan coronavirus vaccine, ABC News reported Tuesday. 

The company reportedly submitted data on numerous booster intervals ranging from two months to six months. It did not formally recommend one to FDA regulators. 

As I previously covered, Johnson & Johnson announced last month that their single-dose vaccine has 94 percent efficacy against moderate-to-severe covid when a booster shot is administered two months after the initial dose. 

In a press release last month, Johnson & Johnson announced their plans for a booster shot and gave an update on the efficacy they were seeing with different intervals.

“When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot,” the press release reads. “When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.”

Currently, only the Pfizer vaccine booster shot has received Emergency Use Authorization from the FDA for adults ages 65 and older and individuals who are high-risk of severe COVID-19. The two-dose Pfizer vaccine against coronavirus is the only vaccine that has the FDA’s full and final approval. Both Johnson & Johnson and Moderna vaccines against covid have received Emergency Use Authorization from the FDA. 

“Both J&J and FDA have a sense of urgency because it’s COVID,” Dr. Mathai Mammen, head of research for J&J's Janssen unit, said to ABC News. “We want good data out there converted into action as soon as possible.”

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