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Coronavirus

FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization

In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization. The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and

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FDA issues updated guidance on adapting Covid-19 vaccines, tests and therapeutics for coronavirus variants

The US Food and Drug Administration has issued updated guidance for companies that plan to adapt their Covid-19 medical products — including vaccines, tests and therapeutics — to address the emergence of coronavirus variants. The agency said in an announcement on Monday that it expects that “manufacturing information will remain generally the same” for authorized

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