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Moderna COVID-19 vaccine gets ready for emergency approval from FDA

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IANS    18 December 2020

A high-powered vaccine advisory panel has endorsed Modernas COVID-19 vaccine for emergency use approval (EUA) through the US Food and Drug Administration (FDA) after an eight-hour debate. This has potentially added a second vaccine into Americas mass immunization drive against the ongoing pandemic.

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 in favour of giving Modernas vaccine shots into the arms of Americans who are 18 years and above, with one expert abstaining. A week ago, the same panel had endorsed Pfizer and BioNTechs Covid-19 vaccine with a 19-4 vote. The EUA was given within the 24 hours. Immunizations by Pfizers vaccine shot startedon 14th December in the US.

On Thursday, the VRBPAC put a single question for vote: "Based on the totality of available scientific data, do the benefits of the Moderna COVID-19 vaccine outweigh their risks for use in people 18 years of age and above?"

If Modernas vaccine gets approved by the FDA, then it will be the 2nd vaccine to be greenlighted in America. Modernas vaccine is also based on the same technology of Pfizers - mRNA. The actual virus is not embedded in these vaccines and people who take the vaccine shots won’t catch the virus. The vaccine holds a piece of genetic code which trains the bodys immune system to identify the spike protein on the surface of the COVID-19 virus and supports an organic defence during the attack. The FDA revealed "no specific safety concerns" or allergic responses in the Moderna trials. Common reactions were temporary fever, fatigue and aches, after the second dose that were similar to the reactions observed in Pfizers vaccine.

Approximately 1.5 percent of vaccine receivers reported possible "hypersensitivity". The Moderna vaccine was above 94 percent effective at preventing coronavirus disease, and 86 percent effective in individuals 65 years and above.

Modernas safety evidence is based on an interim analysis of almost 30,350 participants above 18 years of age who were randomized 1:1 to vaccine or placebo with an average of 7 weeks of follow-up after the 2nd dose.

The US is wanting to vaccinate 20 million individuals by December end, covering healthcare workers and nursing home staff and residents. Around 3 million Pfizer vaccine shots are out for the 1st round of shipments. The government is holding back the 2nd dose to confirm that people who took the first shots also get the second shot. Besides the first round of 6.4 million doses, an extra 500,000 doses are kept for emergencies. States are also getting vaccine doses based on the population 18 years and above.

By February 2021, there will be sufficient vaccines to immunize 100 million Americans. COVID-19 is responsible for more than 300,000 deaths in America this year.

Source: ET Healthworld

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