FDA finds Johnson & Johnson’s one-shot COVID-19 vaccine effective and safe

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Empty vials that contained a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus lie on a table as South Africa proceeds with its inoculation campaign at the Klerksdorp Hospital on February 18, 2021. (Photo by PHILL MAGAKOE/AFP via Getty Images)

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.

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.

Three vaccine recipients had severe side effects in the trial, but the FDA said that its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization.

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection. Occurrence of solicited, unsolicited, and serious adverse events in these subgroups was generally consistent with the overall study population,” the report submitted Wednesday read.

J&J had not previously released details of its clinical trial data beyond efficacy rates.

READ THE FULL BRIEFING BELOW:

Reuters and the Associated Press contributed to this report.

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