FDA Approval Moderna
FDA Approval Moderna – Moderna’s Covid-19 vaccine has received full approval from the US Food and Drug Administration, according to FDA and Moderna reports.
The vaccine called Spikevax is now approved for use in people aged 18 years and older. Its use by young people is not approved or permitted. There is no difference between an approved vaccine and a vaccine previously used for emergency use.
FDA Approval Moderna Update – Moderna is the second Covid-19 vaccine to receive full FDA approval. The Covid-19 vaccine from Pfizer, Comirnaty, was approved for use by people aged 16 and over in August. Pfizer is also approved for use by individuals 5 to 15 years of age.
Moderna said the FDA had based its decision to give full agreement to the scientific evidence that Moderna shared in its submission package to the agency, which includes six months of follow-up data from a phase 3 clinical study, as well as production and required by the FDA. supply data.
“This is a significant milestone in Moderna’s history because it is our first product to be licensed in the United States,” Moderna CEO Stéphane Bancel said in a report. “Spikevax’s full license in the US now joins the license in Canada, Japan, the European Union, the United Kingdom, Israel, and other countries, where the indication for teenagers has also been approved. We are grateful to U.S. FDA for its full review of our application. We are humbled by the role that Spikevax has played in helping to end this pandemic. “
Dr. Janet Woodcock, the acting FDA commissioner, called the approval an “important step” in the fight against Covid-19.
“The public can be confident that Spikevax meets the high FDA standards for safety, efficacy, and production quality required of any vaccine approved for use in the United States,” Woodcock said in a statement. . “While hundreds of millions of doses of Moderna COVID-19 have been given to individuals with emergency use permits, we understand that for some individuals, FDA approval may increase confidence in vaccination decisions.”
The two-dose vaccine has been available in the United States under FDA-approved emergency use since December 18, 2020. Since then, more than 204 million doses of Covid-19 Moderna have been dispensed in the United States, representing approximately 38%. of the total. administered, according to the U.S. Centers for Disease Control and Prevention. Nearly 75 million people have completed their first Moderna vaccination series and about 38.5 million people have received modern revaccinations.
Covid-19 vaccine manufacturers originally applied for emergency use because the FDA Approval Moderna process takes less time than required for full approval.
Emergency use authorization is what the name suggests – a medical product such as a vaccine that receives special FDA approval for emergency use. Once health care ends, “any EUAs issued under this statement will no longer be effective,” the FDA said.
A 50 mg booster fax dose is currently available within the EUA for people over the age of 18. The third 100 mg dose of the vaccine is approved for use in immunocompromised adults.
Source – FDA