02.05.21

J&J Files Single-Dose COVID-19 Vaccine for US Emergency Use

Source: FirstWord

Johnson & Johnson submitted a request to the FDA seeking an emergency-use authorization (EUA) for its COVID-19 vaccine candidate Ad26.COV2.S. Paul Stoffels, the company’s chief scientific officer, called the filing “a pivotal step toward reducing the burden of disease for people globally.”

The submission is based on topline results from the phase 3 ENSEMBLE trial, in which the single-dose inoculation demonstrated 66% efficacy at preventing moderate-to-severe COVID-19 at 28 days post-vaccination, rising to 85% when it came to preventing severe disease, while completely protecting against coronavirus-related hospitalizations and death.

Question of variants

The study, which was conducted at different sites around the world, also revealed differences in effectiveness depending on the region. The level of protection against moderate-to-severe COVID-19 was 72% in the US, but the vaccine was found to be 66% effective in Latin America, where a mutation known as P.1 has been associated with a rise in cases in Brazil. Meanwhile, in South Africa, where a variant called B.1.351 is circulating widely, the vaccine was only 57% effective. Both strains have recently surfaced in the US, although there is no clear indication yet that any are widespread. The FDA has scheduled an advisory panel meeting on February 26 to discuss the application and ENSEMBLE trial findings, with one focus area likely to be the effectiveness of Ad26.COV2.S against new variants of the coronavirus. Johnson & Johnson has previously suggested the EUA could be granted as soon as March.

Stoffels indicated that “upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping.” The company reiterated that it expects to be able to honor its contract with the US to supply 100 million doses in the first half of 2021. Meanwhile, Johnson & Johnson said it has initiated rolling submissions with several health agencies outside the US as well, and will also file for conditional marketing authorisation with the European Medicines Agency in the coming weeks.

FDA developing guidance to tackle mutations

In a separate statement on Thursday, the FDA said it has been communicating with drugmakers and working on guidelines for vaccine developers as they evaluate how their products will be affected by SARS-CoV-2 variants. The agency is “currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine…including how sponsors could demonstrate immune response to new variants through streamlined clinical programs,” said acting FDA Commissioner Janet Woodcock.

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