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FDA Authorizes Johnson Single Shot Vaccine

Johnson & Johnson today [Feb 27] announced that the U.S. Food and Drug Administration [FDA] has issued Emergency Use Authorization for its single-dose Covid-19 vaccine.

“This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination,” the company said.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

The Johnson & Johnson vaccine differs from the other vaccines which have already been approved in that it is a single dose, versus two doses.

Bermuda, which is ranked in the top 10% of all nations worldwide as far as vaccinations per capita, is using the Pfizerv vaccine, which is being supplied to Bermuda and the other Overseas Territories by the UK.

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