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Drugmaker Johnson & Johnson has asked United States regulators for emergency use authorisation of its COVID-19 booster shot, the company announced, as the US government moves to expand its booster campaign to millions of vaccinated Americans.
J&J said on Tuesday that it requested the US Food and Drug Administration (FDA) authorise boosters for people aged 18 and older who previously received the company’s one-shot vaccine.
The drugmaker also said its submission includes data from a late-stage study that found a booster given 56 days after the primary dose provided 94 percent protection against symptomatic COVID-19 in the US and 100 percent protection against severe disease, at least 14 days after the booster shot.
While scientists are divided over the need for booster shots when so many people in the US and other countries remain unvaccinated, the administration of President Joe Biden announced a push for boosters in August to shore up protection against the highly transmissible Delta variant.
“Both J&J 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 J&J’s Janssen unit.
J&J’s filing comes after the FDA last week scheduled an October 15 meeting of its expert advisory committee to discuss whether to authorise a second shot of the company’s single-dose vaccine.
The FDA has already authorised a booster dose of the vaccine developed by Pfizer and partner BioNTech for people aged 65 and older, people at high risk of severe disease, and others who are regularly exposed to the virus.
Pfizer had also asked the FDA to expand its vaccine approval to include boosters for anyone aged 16 and older, but the regulator decided to limit their use saying evidence showed they were helpful to older people and those at high risk.
Vaccine-maker Moderna also submitted an application seeking authorisation for a booster shot of its two-dose vaccine last month, and an FDA panel will hold a meeting on October 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 administration strategies, as needed.
Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the US, with more than 170 million Americans fully vaccinated with the companies’ two-dose shots.
About 15 million Americans aged 18 and older have received J&J’s one-dose vaccine, according to the latest data from the US Centers for Disease Control and Prevention (CDC).