The corona vaccine from the American pharmaceutical company Moderna has received full approval in the United States for people aged 18 and over. This was reported by the health authorities on Monday. Until now, the Moderna vaccine had an emergency approval, which normally expires when the state of emergency ends.
Read all the news about the coronavirus in this file.
Moderna’s vaccine “meets strict standards” set by the US Food and Drug Administration (FDA) for “safety, efficacy and manufacturing quality required for approval,” the FDA said in a statement.
This makes Moderna’s vaccine the second to receive full approval in the US, after Pfizer’s.
The FDA hopes full vaccine approval can give people additional confidence to get vaccinated, Janet Woodcock, chief executive of the US drug agency, said in a statement.
CEO Stéphane Bancel speaks of an important step for Moderna as the vaccine is the company’s first product to be approved in the US. He emphasized that the vaccine has already been administered to tens of millions of people worldwide.
The vaccine was approved in the US in December 2020 through an emergency approval. It is only available to people over the age of 18.
Full approval applies to the first two doses, which may be administered at least one month apart. Emergency approval still applies for the booster dose.
The FDA based its decision on analysis of data from clinical trials in which 15,000 people received the vaccine and 15,000 others received a placebo.
The American Medicines Agency does mention the risk of myocarditis, an inflammation of the heart muscle, with the vaccine. The risk is greatest in young men, ages 18 to 24, within seven days of the second injection.
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