FDA Authorizes Moderna COVID-19 Vaccine for Emergency Use, Marking the Second Vaccine for Virus Prevention

The second COVID-19 vaccine — the Moderna COVID-19 Vaccine — has received emergency use authorization from The Food and Drug Administration (FDA) for the prevention of COVID-19 caused by SARS-CoV-2.

This authorization, which allows Moderna to distribute its vaccine in the U.S., comes exactly a week after the first vaccine by Pfizer-BioNTech was granted emergency use authorization by the FDA.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, MD, in a press release from the Agency. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use that the American people have come to expect from the FDA.”

Data reviewed by the FDA demonstrated that the Moderna COVID-19 Vaccine may be effective in the prevention of COVID-19, and that the benefits outweigh the risks for patients aged 18 years and older. The vaccine contains messenger RNA, which is genetic material, and a small piece of the virus’ messenger RNA that instructs cell to develop a spike protein. Upon receipt of the vaccine, the patient’s body replicates the spike proteins that instead trigger the immune system to defend against SARS-CoV2, according to the release.

“Guided by science and data, the Agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said in the release. “Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process has been maintained.”

Similar to the Pfizer-BioNTech Vaccine, the Moderna COVID-19 Vaccine is administered in two doses one month apart. The most common side effects from the Moderna COVID-19 Vaccine include tiredness, pain at the injection site, muscle pain, headache, joint pain, chills, nausea and vomiting, swollen lymph nodes and fever, all of which can last several days. The release noted that more patients experienced side effects after the second dose rather than after the first dose.

“We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a phase 1, phase 2 and pivotal phase 3 study of 30,000 participants,” said Stéphane Bancel, chief executive officer of Moderna, said in a press release from the company. “It has been a 10-year scientific, entrepreneurial and medical journey, and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

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