US FDA Approves Moderna's Covid Vaccine SPIKEVAX
18:05 GMT 31.01.2022 (Updated: 13:28 GMT 06.08.2022)
© AFP 2023 / JOSEPH PREZIOSOIn this file photo the Moderna logo is seen at the Moderna campus in Norwood, Massachusetts on on December 2, 2020, where the biotechnology company is mass producing its Covid-19 vaccine. - US biotech firm Moderna said on July 7, 2021 it had dosed its first participants in a human study of an mRNA vaccine that targets multiple strains of influenza. The company intends to recruit 180 adults in the United States for the Phase 1/2 portion of the trial to evaluate the safety and strength of immune response to the shot, called mRNA-1010.
© AFP 2023 / JOSEPH PREZIOSO
WASHINGTON (Sputnik) - The US Food and Drug Administration (FDA) has fully approved Moderna’s SPIKEVAX, which can now be administered to people 18 and older to prevent COVID-19, the company announced Monday.
"Moderna... today announced the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older," the company said in a press release.
Moderna CEO Stephane Bancel in the same release said the full licensure of Spikevax is a momentous milestone because it is the company's first product to achieve licensure in the US.
The FDA, according to the release, based its decision on the totality of scientific evidence shared by the company in its submission package, including follow-up data from the Phase 3 COVE study that showed high efficacy and favorable safety around six months after the second dose.
SPIKEVAX, the company added, has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the United Kingdom and Israel.
The company said it shipped 807 million doses of its COVID-19 vaccine worldwide in 2021, with about 25 percent of those doses shipped to low- and middle-income countries.