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Johnson & Johnson requests authorization for COVID-19 vaccine booster shots

Vials of Johnson & Johnson's COVID-19 vaccine
Vials of Johnson & Johnson’s one-shot COVID-19 vaccine.
(Johnson & Johnson)

Johnson & Johnson on Tuesday asked the Food and Drug Administration 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.

Johnson & Johnson said it filed a request with the FDA to authorize boosters for people 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 potentially waning immunity levels.

Government advisors backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and Johnson & Johnson vaccines. At present, U.S. officials do not recommend mixing and matching vaccine brands.

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The FDA is convening its outside panel of advisors next week to review booster data from both Johnson & Johnson and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting Johnson & Johnson and Moderna boosters this month.

A new study confirms the dramatic erosion of the Pfizer-BioNTech COVID-19 vaccine’s protection against breakthrough infections.

Johnson & Johnson previously released data suggesting that 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 two or six months revved up immunity even further. FDA’s advisors will review that data Oct. 15 and vote on whether to recommend boosters.

The timing of the Johnson & Johnson 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 Johnson & Johnson executive said the company has been working with FDA on the review.

“Both Johnson & Johnson 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 Johnson & Johnson’s Janssen unit.

The vaccine from the New Brunswick, N.J., 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 Johnson & Johnson to import millions of doses from overseas.

The U.S. is planning booster doses of the Pfizer and Moderna COVID-19 vaccines, but if you got the one-dose Johnson & Johnson shot instead, stay tuned.

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 vaccine doses. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots, and fewer than 15 million Americans have received the Johnson & Johnson shot.


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