J&J Seeks US Clearance for COVID-19 Vaccine Booster Doses
WASHINGTON (AP) — Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.
J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.
Government advisers backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots. U.S. officials don’t recommend mixing and matching different vaccine brands.
The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S.
But company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot.
FDA’s advisers will review studies from the company and other researchers next Friday and vote on whether to recommend boosters.
The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company’s data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review.
“Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J’s Janssen unit.
The vaccine from the New Brunswick, New Jersey, company was considered an important tool in fighting the pandemic because it requires only one shot. But its rollout was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.
Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks.
Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
In The News
WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for... Read More
WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for concern “but not a cause for panic.” Speaking in the Roosevelt Room of the White House, as Dr. Anthony Fauci, director of the National Institute of... Read More
WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he... Read More
WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he seeks to quell concerns Monday over the new COVID-19 variant omicron, but won't immediately push for more restrictions to stop its spread, his chief medical adviser said.... Read More
WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can... Read More
WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can either reaffirm the constitutional right to an abortion or wipe it away altogether. Roe v. Wade, the landmark 1973 ruling that declared a nationwide right to abortion, is... Read More
WASHINGTON (AP) — Dr. Anthony Fauci, the government’s top infectious diseases expert, blasted Sen. Ted Cruz for suggesting that Fauci... Read More
WASHINGTON (AP) — Dr. Anthony Fauci, the government’s top infectious diseases expert, blasted Sen. Ted Cruz for suggesting that Fauci be investigated for statements he made about COVID-19 and said the criticism by the Texas Republican was an attack on science. “I should be prosecuted? What happened on... Read More
WASHINGTON - The Biden Administration on Friday imposed air travel restrictions on eight African nations in response to a new... Read More
WASHINGTON - The Biden Administration on Friday imposed air travel restrictions on eight African nations in response to a new COVID strain first detected in South Africa. The new travel restrictions, which go into effect Monday, apply to citizens of South Africa, Botswana, Zimbabwe, Namibia, Lesotho,... Read More
BRUSSELS (AP) — A slew of nations moved to stop air travel from southern Africa on Friday, and stocks plunged... Read More
BRUSSELS (AP) — A slew of nations moved to stop air travel from southern Africa on Friday, and stocks plunged in Asia and Europe in reaction to news of a new, potentially more transmissible COVID-19 variant. "The last thing we need is to bring in a... Read More