US regulator set to approve Moderna vaccine after backing of assessment panel

The US regulator says it will move quickly to authorise a second COVID-19 vaccine in the country.

On Thursday, a panel of 20 advisers at the Food and Drug Administration ruled that the benefits of the vaccine outweighed the risks for adults.

Stephen Hahn, commissioner of the FDA, said: “Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, FDA has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation.

“FDA is finalising the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine.

“This is a critical part of what the agency does to promote and protect the public health.”

Dr Hahn added that other government bodies had also been told so they could “execute their plans for timely vaccine distribution”.

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Once emergency authorisation is given, millions of doses of the Moderna vaccine can be shipped and used firstly for health workers and care home residents.

It comes just days after the US started its vaccination campaign using the jab developed by Pfizer and BioNTech.

Moderna says its vaccine provides 94% protection against COVID-19 in an ongoing study of 30,000 people.

FDA advisers spent around eight hours discussing the study and its technical details and, while one panellist abstained from the vote, the others all approved.

Moderna’s vaccine uses pieces of COVID-19’s genetic code to train the immune system to detect and fight the virus.

It requires two doses, four weeks apart.

More than 17 million people have tested positive for the virus in the US, with more than 310,000 people having died with the disease.

Mark Gibson

Graduates in Northwestern University, Evanston, Illinois 1990. Move to Los Angeles California in 2004. Specialized in Internet journalism.

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