WASHINGTON (AP) – Johnson & Johnson on Tuesday asked the Food and Drug Administration to allow additional injections of its COVID-19 vaccine as the US government prepares to expand its recall campaign to millions of vaccinated Americans additional.
J&J said it has filed an application with the FDA to allow recalls for people who have previously received the company’s single-shot vaccine. While the company said it has submitted data on several different recall intervals, ranging from two to six months, it has not formally recommended one to regulators.
Last month, the FDA cleared booster shots of Pfizer’s vaccine for older Americans and other groups with increased vulnerability to COVID-19. This is part of a larger effort by the Biden administration to bolster protection against the delta variant and the potential decrease in vaccine immunity.
Government advisers supported Pfizer’s additional fire, but they were also concerned about creating confusion for tens of millions of other Americans who received Moderna and J&J shots. US officials do not recommend mixing and matching different brands of vaccines.
The FDA is convening its group of external advisers next week to review recall data from J&J and Moderna. This is the first step in a review process that also includes approval from the leadership of the FDA and the Centers for Disease Control and Prevention. If both agencies give the green light, Americans could start getting J&J and Moderna boosters later this month.
J&J previously published data suggesting that its vaccine remains highly effective against COVID-19 for at least five months after vaccination, showing 81% effectiveness against hospitalizations in the United States
But the company’s research shows that a booster dose at two or six months further boosted immunity. FDA advisers will review this data next Friday and vote on whether to recommend boosters.
The timing of J&J’s 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 the meeting announcement. A J&J executive said the company is working with the FDA on the review.
“J&J and the FDA have a sense of urgency because this is COVID and we want good data turned into action as soon as possible,” said Dr. Mathai Mammen, head of research for the Janssen unit of J&J.
The vaccine from the New Brunswick, New Jersey company was seen as an important tool in the fight against the pandemic because it only requires one injection. But its deployment was affected by a series of issues, including manufacturing issues at a Baltimore plant that forced J&J to import millions of doses from overseas.
Additionally, regulators have added warnings about several rare side effects to shooting, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot always outweighed these rare risks.
Rival drugmakers Pfizer and Moderna have supplied the vast majority of America’s COVID-19 vaccines. More than 170 million Americans have been fully immunized with the companies two-dose injections while less than 15 million Americans have received the J&J vaccine.