Johnson & Johnson said it has asked US health regulators to authorize its single-dose COVID-19 vaccine for emergency use, and it will apply to European authorities in the coming weeks.
The drugmaker’s application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report in which it said the vaccine had a 66% rate of preventing infections in its large global trial.
The FDA said on Thursday evening that it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26, to discuss the company’s request for emergency use authorization.
Vaccines from Pfizer Inc/BioNTech SE and Moderna Inc were authorized a day after such a meeting. J&J’s single-shot vaccine could help boost supply and simplify the U.S. immunization campaign, amid concerns of fresh surges due to the more contagious UK coronavirus variant and the potential of lower vaccine efficacy against a variant that first emerged in South Africa.
Unlike the two currently authorized vaccines from Pfizer/BioNTech SE and Moderna, J&J’s does not require a second shot or need to be shipped frozen. After the company’s application, regulators will need time to analyze the data and an advisory committee must meet. The company’s chief scientific officer, Paul Stoffels, said last month J&J was on track to roll out the vaccine in March.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Stoffels said in a statement announcing the application. Shares of Johnson & Johnson rose about 1% in extended trading on Thursday, while Moderna was down 0.7% and Pfizer stock was little changed.