Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval…reports Asian Lite News
Moderna’s Covid-19 vaccine has received full approval from the US Food and Drug Administration (FDA).
The vaccine, named Spikevax, is approved for use in people ages 18 and older, Xinhua news agency reported.
Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval, said the agency in a statement.
“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Acting FDA Commissioner Janet Woodcock.
“Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” she said.
Moderna’s Covid-19 vaccine is the second one in the US to receive full approval from the FDA. Pfizer’s Covid-19 vaccine, Comirnaty, was fully approved for use in people ages 16 and older in August 2021.
Moderna’s Covid-19 vaccine has been available under the FDA’s emergency use authorization for individuals 18 years of age and older since December 18, 2020.
Moderna had earlier began clinical trials of a booster dose of a vaccine designed specifically to combat the Omicron variant of COVID-19.
CNN reported that the trials will involve a total of 600 adults, which will take place at up to 24 sites in the US. Some participants will have already received two doses of Moderna’s vaccine, and some will have received a booster shot.
“We are reassured by the antibody persistence against Omicron at six months after the currently authorized 50 mg booster of mRNA-1273. Nonetheless, given the long-term threat demonstrated by Omicron’s immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase 2 study,” CNN citing CEO Stephane Bancel’s statement reported.
“We are also evaluating whether to include this Omicron-specific candidate in our multivalent booster program,” it added.