Late this evening the FDA granted an Emergency Use Authorization to Moderna for its Covid-19 vaccine. While not surprising given the advice of the FDA’s AdCom yesterday, formal approval allows distribution of the vaccine to begin. This action should add 6 million doses of vaccine to the stockpile for Americans, more than double the doses available.
“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 statement.
Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research added: “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.”
Marks also commented, “This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.”
As mentioned in yesterday’s blog, 20 members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted “yes” to the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.
These achievements should resolve arguments about the approach to ending the pandemic. In the next few days, I will discuss the implications of the vaccination program in the U.S. and when we can expect things to truly get better.