J&J is asking the FDA to authorize its COVID-19 booster shots

Johnson & & Johnson has asked U.S. regulators to allow booster shots of its COVID-19 vaccine.

David Zalubowski/AP

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David Zalubowski/AP

Johnson & & Johnson has asked U.S. regulators to permit booster shots of its COVID-19 vaccine.

David Zalubowski/AP

Rival drugmakers Pfizer and Moderna have supplied the huge majority of U.S. COVID-19 vaccines. More than 170 million Americans have been completely vaccinated with the companies two-dose shots while less than 15 million Americans got the J&J shot.

WASHINGTON– Johnson & & Johnson asked the Food and Drug Administration on Tuesday to enable extra shots of its COVID-19 vaccine as the U.S. government approaches broadening its booster campaign to millions more immunized Americans. J&J said it submitted a demand with the FDA to license boosters for individuals 18 and older who formerly received the companys one-shot vaccine. While the business stated it submitted information on several different booster periods, varying from 2 to six months, it did not formally suggest one to regulators. Last month, the FDA authorized booster shots of Pfizers vaccine for older Americans and other groups with increased vulnerability to COVID-19. Its part of a sweeping effort by the Biden administration to support security in the middle of the delta variation and prospective waning vaccine immunity.

FDAs consultants will review research studies from the business and other scientists next Friday and vote on whether to advise boosters. “Both J&J and FDA have a sense of urgency due to the fact that its COVID and we want excellent data out there transformed into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&Js Janssen unit.

Americans might quickly start getting J&J and Moderna boosters The FDA is assembling its outdoors panel of consultants next week to evaluate booster data from both J&J and Moderna. If both agencies give the go-ahead, Americans might start getting J&J and Moderna boosters later this month.

The vaccine from the New Brunswick, New Jersey, company was considered a crucial tool in combating the pandemic since it needs only one shot. In addition, regulators have included warnings of several rare side impacts to the shot, consisting of a blood clot disorder and a neurological reaction called Guillain-Barré syndrome.

The company has actually not yet launched clinical information on a six-month booster shot.

Information released last month showed providing a booster at two months provided 94% security versus moderate-to-severe COVID-19 infection. The company has not yet launched medical data on a six-month booster shot.

J&J stated it submitted a request with the FDA to license boosters for people 18 and older who previously received the companys one-shot vaccine. Last month, the FDA authorized booster shots of Pfizers vaccine for older Americans and other groups with increased vulnerability to COVID-19. Americans might soon start getting J&J and Moderna boosters The FDA is convening its outdoors panel of advisors next week to review booster information from both J&J and Moderna. If both agencies provide the consent, Americans could begin getting J&J and Moderna boosters later on this month.

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