BREAKING: Moderna’s COVID-19 vaccine receives full FDA approval for Americans aged 18 and older

  • The Moderna Covid-19 vaccine has received full FDA approval for use in all U.S. adults
  • It is the second vaccine to receive full approval for use in America, joining Pfizer’s shot 

By Mansur Shaheen U.S. Deputy Health Editor For Dailymail.Com

Published: 16:21 GMT, 31 January 2022 | Updated: 16:48 GMT, 31 January 2022


Moderna’s COVID-19 vaccine has received full approval from the Food and Drug Administration (FDA) for use in adults in the U.S., the company announced Monday.

Spikevax, as it has been named, is the second Covid vaccine to receive full approval from the FDA, joining Pfizer’s Comirnaty. It was previously used on an emergency use authorization basis. 

Full approval means the shot will still  be available for use once the Covid-related state of emergency ends – which could be sometime this year. It also means the shot is being given an official stamp of approval from regulators that it is safe and effective over a long period of time. 

The shot is among the most effective in the world against the virus and is the second most commonly used shot in the U.S.

It has been used to fully vaccinate 204 million Americans, and has been used as a booster shot 38.4 million times.

‘Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,’ Moderna CEO Stephane Bancel said in a statement.

‘The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved.’ 

The FDA decision was based on a Phase 3 study using data from real world recipients of the vaccine while it was in its emergency use phase.

 

 This story is being updated

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