The Food and Drug Administration (FDA) advisory board voted to recommend that the government authorize Molnupiravir, an antiviral pill discovered by Emory University scientists, for Emergency Use Authorization to treat COVID-19 on Nov. 30.
Molnupiravir works by causing mutations in the SARS-CoV-2 virus during replication. In its clinical trials, Molnupiravir was found to be 30% effective at reducing the risk of hospitalization or death to patients five days after they display symptoms.
The pill was created by Emory scientists George Painter, David Perryman and Dennis Liotta. Painter is the CEO and Co-founder of Drug Innovation Ventures at Emory, an Emory organization centered around translating academic research into drugs that combat viral diseases of global concern.
Molnupiravir has reduced the risk of hospitalization and mortality from COVID-19. The pill may be authorized for use in the U.S. in a matter of days and patients will have access in a matter of weeks.
In addition, this drug is likely to cover millions of Americans struggling with obesity, diabetes and heart disease who face a greater risk of increased illness of COVID-19, according to the Centers for Disease Control and Prevention.
The FDA’s advisory panel, which is composed of experts on antimicrobial drugs, faced a close vote on endorsing Molnupiravir with a vote of 10-13.
Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah, expressed his concern in an interview with The New York Times.
“The risk of widespread effects on potential birth defects, especially delayed effects on the male, has not been adequately studied,” Swaminathan said.
Committee members feared the efficacy of this drug, Swaminathan said. However, Infectious Disease Physician David Hardy told The New York Times that the need for a drug like this seemed to outweigh the potential risks, resulting in its endorsement.
Molnupiravir is expected to be dispensed at pharmacies around the U.S. making it much more accessible to a wider range of people than antibody treatments have been in the past.
Molnupiravir’s clinical trials, however, were only sampled with the Delta, Mu, and Gamma variants of COVID-19. There have been no experiments to show if the drug is effective at blocking replication of the Omicron variant, which was declared a new variant of COVID-19 by the World Health Organization on Nov. 26.
