Moderna announces its Covid vaccine has been fully approved by the FDA

The US Food and Drug Administration (FDA) has granted full approval to Moderna’s Covid-19 vaccine (Picture: Getty Images)

Moderna has announced that the US Food and Drug Administration (FDA) has granted full approval for its coronavirus vaccine.

Announced on Monday morning, the FDA’s action means that health regulators have finished a rigorous review of Moderna’s jab, as it has done for dozens of other non-Covid-19 vaccines.

‘The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,’ the FDA’s top vaccine regulator Dr Peter Marks stated.

Moderna’s vaccine has been administered to tens of millions of Americans since the FDA granted it emergency use authorization more than a year ago.

Moderna’s vaccine has been administered to tens of millions of Americans since it received emergency use authorization from the FDA more than a year ago (Picture: Getty Images)

Over months, the FDA reviewed data that Moderna provided on the effectiveness of its vaccine and examined side effects that have shown to be uncommon.

Moderna’s Covid-19 vaccine is its first product to receive full FDA approval. The Cambridge, Massachusetts-based drugmaker will now market the jab under the name Spikevax.

‘The totality of real-world data and the full (Biologics License Application) for Spikevax in the United States reaffirms the importance of vaccination against this virus,’ Moderna CEO Stéphane Bancel stated.

In the US, only adults are receiving the Moderna vaccine and its booster in a half dose. The FDA delayed its decision on approving the vaccine for 12- to 17-year-olds while looking into the risk of heart inflammation, Moderna said in the fall.

Moderna’s vaccine includes a warning label on a rare heart inflammation condition that has mostly affected young men who have taken the second dose.

The FDA granted full approval to Pfizer’s coronavirus vaccine in August. Johnson & Johnson has not submitted an application to the FDA for full approval of its single-dose Covid-19 jab.

More than 211million, or 63% of all Americans, are fully vaccinated against the coronavirus. About 86million people have received a booster dose. Vaccinations currently average less than 750,000 daily. The peak was last spring, and vaccination rates increased briefly in December amid the Omicron variant surge, but have since dropped.

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