A panel of FDA health experts will meet next week to consider booster shots of the J&J and Moderna vaccines.
Drugmaker Johnson & Johnson has asked U.S. regulators for emergency use of its COVID-19 booster injection, the company announced, as the U.S. government plans to expand its booster campaign to millions of vaccinated Americans.
J&J said Tuesday it has requested the U.S. Food and Drug Administration (FDA) to allow boosters for people 18 and older who had previously received the company’s one-time vaccine.
The drugmaker also said its submission includes data from a late-stage study that showed that a booster 56 days after the primary dose provided 94 percent protection against symptomatic COVID-19 in the U.S. and 100 percent protection against serious illness, at least 14 days after the primary dose. days after the booster shot.
While scientists are divided over the need for booster shots now that so many people in the US and other countries are unvaccinated, President Joe Biden’s administration announced in August that boosters were needed to bolster protection against the highly transmissible Delta strain.
“Both J&J and the FDA have a sense of urgency because it is COVID and we want good data to be turned into action as soon as possible,” said Dr Mathai Mammen, head of research for J&J’s Janssen unit.
J&J’s filing comes after the FDA scheduled a meeting of its expert advisory committee on Oct. 15 last week to discuss whether to approve a second injection of the company’s single-dose vaccine.
The FDA has already approved a booster dose of the vaccine developed by Pfizer and partner BioNTech for people age 65 and older, those at high risk for serious illness and others who are regularly exposed to the virus.
Pfizer had also asked the FDA to expand vaccine approvals to include boosters for anyone 16 years and older, but the regulator decided to restrict their use because there was evidence that they were useful for older people and those with high blood pressure. risk.
Vaccine maker Moderna also filed last month to seek approval for a booster injection of its two-dose vaccine, and an FDA panel will hold a meeting Oct. 14 to discuss that submission.
J&J said it plans to submit the data to other regulators, the World Health Organization and national immunization technical advisory groups to inform decision-making on local vaccine delivery strategies, if necessary.
Pfizer and Moderna have supplied the vast majority of COVID-19 vaccines in the US, with more than 170 million Americans fully vaccinated with the companies’ two-dose injections.
According to the latest data from the U.S. Centers for Disease Control and Prevention (CDC), about 15 million Americans ages 18 and older have received J&J’s single-dose vaccine.