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On Monday, the Food and Drug Administration (FDA) gave full approval to Moderna‘s COVID-19 vaccine for people 18 years of age and older.
The approval makes it the second vaccine to be fully licensed in the United States. The vaccine will be marketed as Spikevax.
Moderna’s messenger RNA vaccine has been available under an Emergency Use Authorization since December 2020.
“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 FDA’s rigorous scientific standards,” said FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks.
“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 Moderna vaccine has also been authorized for use as a heterologous single booster dose, more commonly referred to as a “mix-and-match” dose, meaning it can be used in combination with another approved vaccine.
In August, Pfizer’s COVID-19 vaccine became the first to receive full FDA approval.
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 FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said Acting FDA Commissioner Janet Woodcock.
