Moderna Vaccine Gets FDA Emergency Approval

By Tony Winterburn • Published: 19 Dec 2020 • 9:11

Moderna developing annual joint flu and Covid vaccine. image: Moderna Press

Moderna vaccine gets FDA emergency approval making it the second jab in the US to get the green light.

The US Food and Drug Administration (FDA) has granted emergency authorisation to a coronavirus vaccine developed by pharma firm Moderna, the second immunisation to pass tests with American regulators.

“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in announcing the move on Friday, Dec. 18, hailing the agency’s “open and transparent scientific review process.”

The decision comes after President Donald Trump suggested earlier on Friday that the jab was “overwhelmingly approved” and that mass distribution would begin “immediately,” though the FDA had made no public announcement at the time. Moderna’s vaccine is 94% effective at preventing Covid-19 and is authorised in adults 18 and older. The authorisation comes after it was recommended by an FDA advisory panel of independent experts.

“I would anticipate that we likely will see shots in the arm by the very early part of next week,” said Dr Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID). Unlike the Pfizer vaccine, the Moderna vaccine deliveries will be managed by the federal government, using funding from Operation Warp Speed, the Trump administration’s program to quickly develop and disseminate Covid-19 vaccines and treatments.

The company’s vaccine proved safe and effective in a diverse population of people, including African-American and Latinx groups, an important data point since these populations have been disproportionately affected by the pandemic and would likely benefit most from immunisation.

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