On Monday, the Food and Drug Administration (FDA) gave complete approval to Moderna's Covid-19 vaccine 'Spikevax'. It is the second-most widely used Coronavirus vaccind in the United States and the second to receive full regulatory approval. This Covid vaccine can be administered to adults and has proved to be highly effective in preventing virus infections and severe symptoms of COVID-19. And, it has been in use for more than a year under emergency-use authorization (EUA),. The standard rules let federal regulators allow use of the vaccine in public health emergency before they get a more detailed review. Spikevax earlier received emergency-use authorization in December 2020.
The complete approval of Moderna’s vaccine, which was expected to come through five months after the company finalised the application for regulators, and after Pfizer and its partner BioNTech, the makers of a similar vaccine received federal approval in the month of August for administration in people 16 years and older. More than 204 million doses of the Moderna Coronavirus vaccine have been administered in the US till now, and around 75 million people have been fully vaccinated with it, as per the Centers for Disease Control and Prevention.
On Monday, Dr. Janet Woodcock, the acting FDA commissioner, said, “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated." The full approval also enables Moderna to sell its vaccine under the name Spikevax and can allow doctors to prescribe usage of this vaccine. Under emergency use authorization, the administration rules were stricter.
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Like the Pfizer-BioNTech vaccine, the Moderna vaccine is also associated with severe but rare heart-related side effects like myocarditis, or inflammation of the heart muscle, and pericarditis or inflammation of the lining around the heart. These health conditions can also occur due to COVID-19 and are mostly mild. The side effects have shown to be common in young men. The side effects made experts rethink about the use of spikevax vaccine in adolescents.