The U.S. FDA Has Just Authorized Its First Coronavirus Vaccine

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The U.S. FDA Has Just Authorized Its First Coronavirus Vaccine

The Pfizer vaccine is expected to be distributed nationwide within hours—for emergency use only.

On Friday, the U.S. Food and Drug Administration (FDA) issued its first emergency use authorization for a COVID-19 vaccine by the pharmaceutical behemoth, Pfizer. It’s expected to be distributed across the country within hours, allowing millions of high-risk individuals to begin receiving the vaccine in a matter of days. This authorization provides hope for a nation that has grappled with the deadly pandemic for 9 tumultuous months, with over 295,000 lives lost due to the respiratory virus.

The vaccine, developed in partnership with the German biotechnology company BioNTec, has been through rigorous testing by the FDA and has shown to be 95% effective in preventing the disease for people aged 16 and older in a late-stage trial. According to the FDA’s data, the drug’s potential benefits outweigh the known and potential risks.

Healthcare workers, nursing home staff and the elderly will be among the first 2.9 million to receive shots. According to officials, around 20 million doses are expected to be delivered by the end of the year.

This vaccine’s speedy development is seen as an extraordinary achievement in innovation and collaboration. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” said FDA Commissioner Stephen M. Hahn, M.D

Although the drug has met the FDA’s satisfactory standards without sacrificing quality, safety, or effectiveness, this is still not an approval. However, the authorization will allow more people to access the drug and its potential benefits.

The vaccine contains genetic material RNA (mRNA) and a small amount of the SARS-CoV-2 virus’s mRNA that “instructs cells in the body to make the virus’s distinctive “spike” protein,” the FDA’s announcement states. This activates an immune system response against SARS-CoV-2 without causing the disease.

More information about the vaccine and testing can be found on the FDA’s website here.

Featured Image: National Cancer Institute via Unsplash

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