David Zalubowski / AP
WASHINGTON – Johnson & Johnson asked the Food and Drug Administration Tuesday to approve additional shots of its COVID-19 vaccine as the U.S. government expands its booster campaign to include millions more vaccinated Americans.
J&J said it had filed an application with the FDA to approve booster vaccinations for people 18 and older who previously received the company’s single-use vaccine. While the company said it provided data on several different booster intervals ranging from two to six months, it did not officially recommend regulators.
Last month, the FDA approved booster shots of the Pfizer vaccine for older Americans and other groups at increased susceptibility to COVID-19. It is part of a broader effort by the Biden government to step up protection amid delta variant and potentially waning vaccine immunity.
Government advisors supported the additional Pfizer shots but were also concerned that they could cause confusion to the tens of millions of other Americans who received the Moderna and J&J shots. US officials do not recommend mixing and combining different brands of vaccine.
Americans could soon start getting boosters from J&J and Moderna
The FDA is convening its external advisory panel next week to review J&J and Moderna’s booster data. It is the first step in a review process that includes approval from the FDA and Centers for Disease Control and Prevention leadership. If both agencies give the go-ahead, Americans could get J&J and Moderna boosters later this month.
J&J previously released data suggesting that its vaccine remains highly effective against COVID-19 for at least five months after vaccination, showing 81% effectiveness against hospital stays in the United States.
But company research shows that a booster dose after either two or six months boosts immunity even further. Data released last month showed that giving a booster vaccine after two months offered 94% protection from moderate to severe COVID-19 infection. The company has not yet released clinical data on a six-month booster dose.
FDA advisors will review studies by the company and other researchers next Friday and vote on whether boosters are recommended.
The timing for filing the J&J filing was unusual as the FDA had already scheduled its corporate information meeting. Companies typically submit their applications well in advance of the announcement of meetings. A J&J executive said the company worked with the FDA on the review.
“Both J&J and the FDA have a sense of urgency as this is COVID and we want good data to be translated into action as soon as possible,” said Dr. Mathai Mammen, Head of Research at J & J’s Janssen Unit.
The New Brunswick, New Jersey company’s vaccine was considered an essential tool in the fight against the pandemic, as only one shot is required. However, the introduction was hampered by a number of issues, including manufacturing issues at a Baltimore factory that forced J&J to import millions of cans from overseas.
In addition, regulators have added warnings of several rare side effects to the injection, including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot still outweighed these unusual risks.
Competing drug makers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans were fully vaccinated with the company’s two-dose vaccinations, while fewer than 15 million Americans received the J&J vaccination.