Moderna COVID-19 Vaccine Now FDA Authorized: What That Means

The US Food and Drug Administration has just announced its second Emergency Use Authorization for a COVID-19 vaccine, paving the way for vaccination of the public against SARS-CoV-2, the virus that can cause COVID-19. This second EUA was given to Moderna for its two-dose mRNA vaccine, this authorization following a similar one given to Pfizer just days ago.

Moderna's SARS-CoV-2 vaccine is designed to reduce the severity or entirely prevent the development of COVID-19, the respiratory disease caused by the novel coronavirus. The Emergency Use Authorization (EUA) is not approval, mind.

Rather, the agency has granted the use of Moderna's mRNA vaccine during the pandemic due to the severity of the virus and evidence demonstrating the product's safety and effectiveness. In a statement, FDA director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, said:

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 have been maintained. 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 with Pfizer's vaccine, Moderna's product must be administered in two doses — in this case, each one month apart. Likewise, the Moderna vaccine may cause similar side effects, including headache, muscle pain, tiredness, joint pain, fever, as well as some other possible things like swollen lymph nodes near where the injection was given and vomiting.

The Moderna vaccine is authorized for use with adults ages 18 and older. With the EUA now in place, Moderna plans to ship millions of doses in the US — according to the New York Times the company will distribute 5.9 million vaccines across the nation starting tomorrow, with the first deliveries arriving on Monday.