WASHINGTON – Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow additional shots of its COVID-19 vaccine as the US government moves to expand its booster campaign to millions more vaccinated Americans.
J&J said it filed a request with the FDA to authorize boosters for people age 18 and older who had 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 has not formally recommended one to regulators.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with high vulnerability to COVID-19. It is part of a broader effort by the Biden administration to shore up the protection between the delta version and potential waning vaccine immunity.
Government advisers supported the additional Pfizer shots, but they were also concerned about causing confusion for the millions of other Americans who received Moderna and J&J shots. US officials do not recommend mixing and mixing different vaccine brands.
The FDA is convening its external panel of advisors next week to review booster data for both J&J and Moderna. It is the first step in the review process that also includes sign-offs from both the FDA and the Centers for Disease Control and Prevention. If both agencies go ahead, Americans may start getting J&J and Modern boosters later this month.
J&J previously released data suggested its vaccine remains highly effective against COVID-19 for at least five months after vaccination, demonstrating an 81% effectiveness against hospitalization in the US.
But the company’s research shows that immunity increases even more with a booster dose in two or six months. Data released last month showed that giving a booster over two months provides 94% protection against moderate to severe COVID-19 infection. The company has yet to release clinical data on the six-month booster shot.
FDA advisors will review studies by the company and other researchers next Friday and vote on whether to recommend the booster.
The timing of the J&J filing was unusual because the FDA had already scheduled its meeting on the company’s data. Companies typically submit their requests prior to completing announcements. A J&J executive said the company is working with the FDA on the review.
“There is a sense of urgency in both J&J and the FDA because this is COVID and we want good data to be converted into action as quickly as possible,” said Dr. Mathai Maimon, head of research at J&J’s Janssen unit.
The vaccine from the New Brunswick, New Jersey, company was considered a vital tool in fighting the pandemic because it requires only one shot. But its rollout was hurt by several troubles, including manufacturing problems at the Baltimore factory, which forced J&K to import millions of supplements from overseas.
Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot still outweighed those unusual risks.
Rival drugmakers Pfizer and Moderna have provided the vast majority of US COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots, while less than 15 million Americans have received the J&J shot.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.
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