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Tipsheet

Johnson & Johnson Seeks FDA Approval for Booster Shots for Adults

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. 

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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.”

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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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