The
The approval makes it the second vaccine to be fully licensed in
"Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the
"Spikevax has the same formulation as the EUA Moderna COVID-19 vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine to provide the COVID-19 vaccination series," reads the FDA website.
The
In August,
The vaccine contains a small piece of the virus's messenger RNA, or mRNA, that instructs the body's cells to make the virus's distinctive spike protein. The body then manufactures copies of the spike protein, triggering an immune system response against the virus.
Data submitted to the FDA demonstrated that Spikevax was 93% effective in preventing infection. The vaccine was also 98% effective in preventing severe disease. However, the data was accrued before the Omicron variant of the virus emerged.
The agency conducted its own benefit-risk assessment and "determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older," according to a statement.
"The
"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."
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