FDA Authorizes Moderna's COVID-19 Vaccine For Emergency Use
The FDA Clears Moderna's COVID-19 Vaccine For Emergency Use, a Week After Pfizer's Approval
Update, Dec. 18: On Friday evening, the Food and Drug Administration (FDA) authorized Moderna's request for emergency use, allowing the second COVID-19 vaccine to be distributed in the US. The news comes just a week after the FDA granted the Pfizer-BioNTech vaccine approval for emergency use.
"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 authorization that the American people have come to expect from the FDA," said FDA Commissioner Stephen Hahn, MD, according to a press release. "These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency's career staff."
Almost six million doses of the Moderna vaccine will be shipped starting Sunday and delivery will begin on Monday, according to The New York Times. As predicted, the first shots can be administered as early as Dec. 21.
Original post, Nov. 30: On Nov. 30, Moderna announced it will submit a request to the US Food and Drug Administration as well as the European Medicines Agency to authorize its coronavirus vaccine for emergency use. The request came Monday after Moderna shared data showing that its vaccine is 94.1 percent effective and that its study of 30,000 people has met the scientific criteria necessary to prove its vaccine works. These findings are in line with previous data released on Nov. 16 showing the vaccine to be 94.5 percent effective. The data also shared that the vaccine was 100 percent effective at preventing severe cases of coronavirus.
According to Moderna, efficacy of the vaccine was consistent across age, race and ethnicity, and gender demographics. The company continues to monitor safety data, but since Nov. 16 when it shared that the only concerns were mild side effects including pain or redness at the injection site, fatigue, fever, muscle and joint pain, and headaches, no new serious safety concerns have been identified.
According to a New York Times interview with Stéphane Bancel, Moderna's chief executive, if authorization is granted, the first shots could be administered as early as Dec. 21. Bancel said the company was "on track" to produce 20 million doses by the end of December and 500 million to a billion in 2021. Since both vaccines require two shots, 20 million doses would be enough for 10 million people.
Moderna is just behind Pfizer and its German partner BioNTech, which over a week ago asked FDA regulators to approve their COVID-19 vaccine for emergency use in the US. The vaccine also requires two doses per person, and Pfizer said it can produce up to 50 million doses this year with about half going to the United States.
Anthony Fauci, MD, director of the National Institute of Allergies and Infectious Diseases, projects that both vaccines will be available to high-risk people by December and to the general public by spring 2021. While this gives us hope, Fauci said it's important to continue with necessary health precautions including universal and uniform wearing of masks, avoiding situations congregating in crowds, keeping physical distance, doing things outdoors rather than indoors even as the weather gets colder, and washing your hands as frequently as you can.
POPSUGAR aims to give you the most accurate and up-to-date information about the coronavirus, but details and recommendations about this pandemic may have changed since publication. For the latest information on COVID-19, please check out resources from the WHO, CDC, and local public health departments.