FDA backs Johnson & Johnson COVID vaccine as safe, effective

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FDA backs Johnson & Johnson COVID vaccine as safe, effective

The Food and Drug Administration backed Johnson & Johnson’s single-dose coronavirus vaccine as safe and effective on Wednesday as the agency weighs whether to clear the shot for emergency use.

FDA staff affirmed J&J’s finding that the vaccine was 66 percent effective overall at preventing moderate and severe cases of COVID-19.

While not as strong as Pfizer and Moderna’s two-dose vaccines, that efficacy rate could still make J&J’s shot a helpful weapon in the battle against the pandemic.

New Jersey-based J&J’s clinical trial of nearly 44,000 people also produced no significant safety concerns that would prevent the FDA from granting an emergency use authorization for the vaccine, agency officials said.

The FDA released its analysis of the shot before a Friday meeting of its Vaccines and Related Biological Products Advisory Committee, a panel of experts that will recommend whether to clear the J&J vaccine for emergency use.

The FDA granted emergency approvals for the Moderna and Pfizer vaccines in December following positive recommendations from the advisory panel.

With Post Wires



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