New Brunswick, NJ – Johnson & Johnson said on Tuesday that it has asked the US Food and Drug Administration to authorize a booster shot for its single-dose COVID-19 vaccine as the government seeks to expand its booster program.
company said in a statement that it submitted the data to the agency, which was seeking authorization for Americans 18 and above who had previously received the J&J vaccine.
While J&J said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.
Dr. Mathai Maimon, global head of Janssen research and development, said, “Our clinical program has found that our COVID-19 vaccine boosters increase the level of protection for people who have received our single-shot vaccine. have received.” “We look forward to our discussions with the FDA and other health officials to support our decisions regarding the booster.”
Maiman continued: “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides robust and prolonged protection remains a critical component to immunizing the global population.”
FILE – A physician’s assistant prepares a shot of Johnson & Johnson’s COVID-19 vaccine in a primary care physician’s office. (Photo by Wolfgang Kum/Images combine via Getty Images)
J&J previously released data suggesting its vaccine remains highly effective against COVID-19 for at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the US, But its research also shows that even a booster dose every two to six months leads to an even greater increase in immunity.
The FDA advisory panel will convene next week to review the booster data from 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.
“There is a sense of urgency in both J&J and the FDA because this is COVID and we want the good data to turn into action as quickly as possible,” Maimen said.
The FDA has already authorized booster shots of Pfizer’s vaccine for people who are immunocompromised, Americans 65 and up, and other groups most susceptible 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.
Pfizer and Moderna have made most of the US COVID-19 vaccines available. 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.
Because the J&J vaccine requires only one shot, it was considered a vital tool in fighting the pandemic when it received an emergency use authorization by the FDA on February 27. Baltimore factory that forced J&K to import millions of supplements from abroad.
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.
J&J said it also plans to submit the data to other world regulators.
This story was reported from Cincinnati. The Associated Press contributed.