Moderna’s Covid-19 vaccine nears approval for use in US

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The coronavirus disease 2019 (Covid-19) vaccine manufactured by US biotech firm Moderna is safe and effective enough for emergency use in the United States, scientists at the country’s Food and Drug Administration said on said Tuesday.

The researchers issued their opinion in a 53-page report ahead of Thursday’s meeting of the agency’s Vaccines and Related Biological Products Advisory Committee, a group of outside medical experts who will advise FDA Commissioner Stephen Hahn on whether to approve emergency use authorization for the vaccine.

The committee and the FDA took the same steps to approve the vaccine developed by Pfizer and BioNTech last Friday and the first vaccinations were given to health workers on Monday.

“FDA has determined that [Moderna] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the scientists wrote in their assessment of Moderna’s clinical trial data.

Moderna said last month its two-dose mRNA-1273 vaccine was more than 94-percent effective in preventing Covid-19 among participants in a 30,000-volunteer clinical trial. The FDA review confirmed that finding and said the vaccine is highly protective for adults and prevents severe cases of the coronavirus disease.

Like Pfizer’s, Moderna’s is a new type “messenger RNA” vaccine that uses strands of genetic material from the coronavirus to activate the body’s immune system, rather than employing a whole, deactivated virus as traditional vaccines do.

Tuesday’s FDA report came on the same day several states are planning to administer their first doses of the Pfizer-BioNTech vaccine. Thousands of additional doses will begin arriving at many US hospitals. CURRENTPH

-PC


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