FDA Green Lights Moderna's COVID-19 Vaccine

The FDA granted an Emergency Use Authorization (EUA) mRNA-1273 for the prevention of COVID-19. The vaccine is the first product that pharmaceutical company Moderna has ever brought to market and is the second COVID-19 vaccine that received the green light from the FDA.

Like the first vaccine approval, frontline health care workers may be among the first in line to be given the shot, which was co-developed by Moderna and the National Institute of Allergy and Infectious Disease (NIAID).

“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.

In an interim analysis of the phase 3 COVE trial investigating mRNA-1273, the vaccine had an efficacy rate of 94.5%. The placebo-controlled trial included more than 30,000 individuals — 25,654 were given 2 injections of mRNA-1273, spread out by 1 month, and the other half were given placebo.

On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 20-0 to grant mRNA-1273 in favor of mRNA-1273’s benefit-to-risk ratio. There was 1 abstention.

“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. 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,” Hahn said.

The meeting also consisted of a public hearing, where experts in their field could take the floor and share their thoughts on the new vaccine. Many, including Robert Wong, MD, emphasized health care disparities that have only worsened since the start of the COVID-19 pandemic in March 2020.

“Even prior to the COVID-19 pandemic, ethnic minority and vulnerable populations suffer significant health care disparities from receiving timely screening and surveillance exams, to delays and access to life-saving treatments,” Wong, a clinical associate professor at Stanford University said.

Wong mentioned that more people are missing out on important cancer screening, which could cause an increase in later-stage diagnoses and cancer-related death down the line.

“In the past 9 months since the pandemic began in the US, we have seen these disparities exacerbated, as our attempt to deliver high-quality care has been disrupted by this pandemic. Patients [are] avoiding care due to fear of venturing out to medical visits for labs or imaging for cancer screening,” he said.

However, while many clinical trials tend to miss the mark when it comes to diversity, the COVE trial included more than 6,000 Hispanic people, more than 3,000 African American people. Further, more than 8,000 people enrolled were living with a chronic disease, 25% were over 65 years of age, and 22% were health care workers.

“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,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.