The Food and Drug Administration has given total permission to Moderna as the second COVID-19 vaccine manufacturer (FDA).
The Moderna vaccine, which will be sold as Spikevax, was previously used with FDA Emergency Use Authorization (EUA) in response to the COVID-19 pandemic.
Moderna’s vaccine was subjected to “rigorous scientific criteria,” according to the FDA, which took into account the company’s manufacturing processes, test methodologies, and manufacturing facilities.
“The FDA’s clearance of Spikevax is a critical step forward in the battle against the COVID-19 pandemic,” stated Janet Woodcock, acting FDA commissioner. “The public may be certain that Spikevax complies with the FDA’s stringent safety, efficacy, and manufacturing quality requirements for any vaccine licensed for use in the United States.” While hundreds of millions of doses of the Moderna COVID-19 Vaccine have been given out under emergency use permission, we appreciate that FDA approval of this vaccine may give some people more confidence in being vaccinated.”
Modern’s continuing randomized, placebo-controlled, blinded clinical study found the vaccination to be 98 percent effective in avoiding “severe illness,” according to the FDA. The experiment followed 14,287 people given the vaccination and 14,164 people given a placebo. All of them were above 18.
While the data was taken before the Omicron variant spread, it revealed that the vaccination was 93% successful in preventing COVID-19, with 55 people in the controlled vaccine group acquiring the illness and 744 persons in the placebo group testing positive for COVID.
The FDA looked into side effect data for those who developed myocarditis and pericarditis and discovered that the cases occurred within 7 days of the second dose, with males between 18 and 24 having the highest risk.
Moderna’s Spikevax vaccine, according to the FDA, can be administered interchangeably with current vaccinations in use under Emergency Use Authorization.