Moderna’s COVID-19 “Spikevax” vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US.
Janet Woodcock, the acting FDA commissioner, said in a statement that “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.”
“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,” Woodcock said.
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Age 18 or older is the minimum requirement for obtaining the Moderna vaccine.
A Pfizer’s vaccine for individuals aged 16 or older was approved by the FDA at the end of August.
Woodcock expressed the hope that FDA approval of the Moderna vaccine will help more people feel at ease and “may instill additional confidence in making the decision to get vaccinated.”
The FDA move was deemed a “momentous milestone” for the company by CEO Stephane Bancel.
“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,” Bancel said in a statement.
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The Moderna vaccine was approved for emergency use in December 2020.
Moderna has full FDA approval for only the first two doses, emergency use authorisation remains in effect for the booster dose.
A clinical trial that evaluated the effectiveness of Spikevax involved 14,287 vaccination recipients and 14,164 placebo recipients, according to the FDA.
In clinical trials, participants reported pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea and vomiting, and swollen lymph nodes as the most common side effects.
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According to the FDA, men aged 18 to 24 were said to be more likely to develop myocarditis or inflammation of the heart muscle, and pericarditis, or inflammation of the surrounding tissue, following vaccination with the second dose.
Despite this, the FDA said it had determined that the “benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.”
(With inputs from agencies)
