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FDA fully approves Moderna COVID-19 vaccine

 


On Monday, the Food and Drug Administration (FDA) gave Moderna full approval for the COVID-19 vaccine and voted for additional confidence in its safety and efficacy.

Full approval for people over the age of 18 was based on follow-up data showing “high efficacy and good safety about 6 months after the second dose”.

The vaccine was already available under an emergency use authorization from December 2020, but full approval is further emphasized.

FDA Deputy Commissioner Janet Woodcock said the move hopes to give some people more confidence in the vaccine.

“People can be confident that Spikevax meets the FDA’s high standards for safety, efficacy and manufacturing quality for vaccines approved for use in the United States,” she said in a statement. .. 19 Vaccines were given to individuals under an emergency use authorization. We understand that for some individuals, FDA approval of this vaccine may instill more confidence in making the decision to be vaccinated. “

The Pfizer vaccine was already fully approved in August.

“Our COVID-19 vaccine is given to hundreds of millions of people around the world and protects them from COVID-19 infections, hospitalizations and deaths,” said Moderna CEO Stéphane Bancel. Stated in a statement.full [approval] Spikevax in the United States reaffirms the importance of vaccination against this virus. This is an important milestone in Moderna’s history as it is the first product licensed in the United States. “

A booster vaccination with the Moderna vaccine is also recommended 5 months after the second vaccination.

Currently, about 74% of adults are fully vaccinated, according to data from the US Centers for Disease Control and Prevention. According to public health agencies, the number of boosters is much smaller, which is important for achieving higher protection against Omicron variants, with 44% of fully vaccinated adults receiving boosters.

Sources

1/ https://Google.com/

2/ https://thehill.com/policy/healthcare/592072-fda-fully-approves-moderna-covid-19-vaccine-company-says

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