COVID-19 mRNA vaccine that uses fundamental Penn technology receives FDA approval

The U.S. Food and Drug Administration (FDA) has given the first full approval to a COVID-19 mRNA vaccine, which uses modified mRNA technology invented and developed by scientists in the Perelman School of Medicine, whose years of research in mRNA science laid a critical piece of the foundation for the largest global vaccination campaign in history.

Katalin Karikó and Drew Weissman look at a computer monitor wearing face masks.
Katalin Karikó, an adjunct professor of Neurosurgery at Penn and a senior vice president at BioNTech, and Drew Weissman, the Roberts Family Professor in Vaccine Research. (Image: Penn Medicine News)

A research partnership between Drew Weissman, the Roberts Family Professor in Vaccine Research, and Katalin Karikó, an adjunct professor of neurosurgery at Penn and a senior vice president at BioNTech, dating back two decades led to the development of modified mRNA technology that has been licensed as a key foundational component of the highly effective Pfizer/BioNTech mRNA COVID-19 vaccine being deployed worldwide. The Pfizer/BioNTech vaccine was the first to receive FDA Emergency Use Authorization (EUA) in December 2020 for those 16 years of age or older, the age group for which the full vaccine approval applies. In May 2021, the EUA was expanded to include adolescents ages 12 to 15 and, in August, it was amended again to allow for a third dose for certain people who are immunocompromised. The vaccine remains available under EUA for these groups. Moderna Therapeutics, which was granted EUA for its mRNA COVID-19 vaccine in December, also uses the same modified mRNA technology created at Penn.

“We are tremendously proud to celebrate this milestone today, and to recognize its roots at Penn, where Drs. Weissman and Kariko’s commitment and vision led to discoveries which have contributed to one of the world’s most impactful scientific achievements,” says J. Larry Jameson, executive vice president of the University of Pennsylvania for the Health System and dean of the Perelman School of Medicine. “Today’s FDA approval should provide even more confidence in the safety and efficacy of COVID-19 vaccines as the fight against this deadly virus continues and encourage everyone who is eligible and has not yet received a vaccine to take this lifesaving step to protect themselves and those around them.”

This story is by Alex Gardner. Read more at Penn Medicine News.