WASHINGTON (NewsNation Now) — U.S. Food and Drug Administration staff say Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, paving the way for its approval for emergency use.
FDA staff confirmed in a report released Wednesday that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19. The agency also said J&J’s shot — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.
In a statement, Colorado Gov. Jared Polis said the news was thrilling.
“I’m thrilled that a third safe and highly effective vaccine will soon arrive in Colorado. Having a vaccine that only requires one dose will help us move more quickly to end the pandemic, and I encourage the federal government to not only approve, but ramp up supply as quickly as possible. We are ready to use many more vaccine doses than we are currently receiving each week,” he said.
Several weeks ago, the drug manufacturer asked U.S. health regulators to authorize its single-dose vaccine for emergency use. Now, an FDA panel of independent experts plans to meet on Friday to decide whether to approve the shot. The FDA is expected to make a final decision within days.
While it is not bound to follow the advice of its experts, the FDA did so when authorizing the Pfizer and Moderna’s vaccines.
J&J’s vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.
Its effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease.
The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.
Read the Johnson & Johnson COVID-19 vaccine briefing document here.
Reuters and the Associated Press contributed to this report.