Coronavirus: Moderna completes submission to seek full FDA approval for COVID-19 vaccine

Officials with Moderna announced Wednesday that the biotechnology company has completed the rolling submission process to get full approval of its COVID-19 vaccine from the Food and Drug Administration.

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As part of the submission for its Biologics License Application, Moderna officials said they asked the FDA for priority review of its documentation.

Officials began the process to seek a BLA from regulators in June. Moderna CEO Stephane Bancel said in a statement Wednesday that the submission “is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history.”

“I want to thank the people who participated in our clinical studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus,” Bancel said.

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“I would again like to thank our partners at (the National Institutes of Health), (the National Institute of Allergy and Infectious Diseases) and (the Biomedical Advanced Research and Development Authority) who have helped us advance the clinical development of our mRNA COVID-19 vaccine. I would also like to thank the U.S. FDA for their hard work and guidance through the BLA submission process and the entire Moderna team for their relentlessness in pursuing our mission of delivering on the promise of mRNA science.”

The announcement comes days after the FDA gave full approval to Pfizer and BioNTech for use of their COVID-19 vaccine in people aged 16 and older.

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The data submitted by Moderna officials to the FDA include an analysis that showed the company’s vaccine to have 93% efficacy six months after the administration of the vaccine’s second dose. Officials said adverse reactions to the vaccine included pain, swelling or reddening at the injection site, fatigue, headache, chills, nausea, fever and muscle or joint pain.

The Moderna vaccine has been available to people aged 18 and older under an emergency use authorization since December 2020. Since then, 143.7 million vaccine doses have been administered nationwide, according to data from the Centers for Disease Control and Prevention. Nearly 64.9 million people have so far been fully vaccinated with the two-dose mRNA vaccine.

Research has shown that vaccinated people can spread the highly contagious delta variant of the virus, which accounts for more than 80% of the COVID-19 cases reported in recent weeks. However, health officials have emphasized that fully vaccinated people are well protected against severe illness and death due to COVID-19.

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As of Tuesday, more than 51% of the U.S. population, or 171.3 million people, have been fully vaccinated against COVID-19, according to the CDC. Officials said 202 million people, or about 61% of the population, have gotten at least one dose of one of the available vaccines.

Since the start of the pandemic, officials have reported more than 38 million COVID-19 cases nationwide, resulting in over 630,800 deaths, according to a tally from Johns Hopkins. Globally, 213.4 million COVID-19 cases have been reported, resulting in 4.4 million deaths, according to Johns Hopkins.