FDA approves COVID-19 mRNA vaccine that uses Penn’s core technology

The United States 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 at the Perelman School of Medicine in the United States. University of Pennsylvania, whose years of research into the science of mRNA laid the groundwork for the largest global vaccination campaign in history.

A two-decade research partnership between Drew Weissman, MD, PhD, the Roberts family professor of vaccine research, and Katalin Karikó, PhD, assistant professor of neurosurgery at Penn and senior vice president of BioNTech, has led the development of mRNA technology which has been approved as a key fundamental component of the highly effective Pfizer / BioNTech COVID-19 mRNA vaccine being deployed worldwide.

The Pfizer / BioNTech vaccine was the first to receive Emergency Use Clearance (EUA) from the FDA in December 2020 for those 16 years of age or older, the age group for which full vaccine approval s ‘applied. In May 2021, the EUA was expanded to include adolescents aged 12 to 15, and in August it was again changed to allow a third dose for some immunocompromised people. The vaccine remains available under EUA for these groups. Moderna Therapeutics, which obtained EUA for its COVID-19 mRNA vaccine in December, also uses the same modified mRNA technology created at Penn.

We are extremely proud to celebrate this milestone today and to recognize its roots in Penn, where Drs. The commitment and vision of Weissman and Kariko led to discoveries that have contributed to one of the most significant scientific achievements in the world. FDA approval today is expected to give even more confidence in the safety and efficacy of COVID-19 vaccines as the fight against this deadly virus continues and encourage all who are eligible and have not. still received vaccine to take this life-saving step to protect themselves and those around them. them.”

J. Larry Jameson, MD, PhD, Executive Vice President, University of Pennsylvania for Health System and Dean of Perelman School of Medicine

For more than a decade, Weissman and Kariko have worked to chemically modify mRNA so that it can be used safely and effectively in vaccines. Many vaccines boost immunity and prepare the body to fight a specific virus by using a weakened or dead version of the real virus. MRNA vaccines, however, carry a genetic code that causes cells in the body to produce proteins that the immune system recognizes as the virus. The immune system then builds the necessary defenses against viral proteins to protect against future infection and serious illness.

Prior to the groundbreaking research by Weissman and Kariko, published in 2005, mRNA vaccines developed to prevent infectious diseases did not effectively and safely elicit protective responses of the immune system in animal models. Weissman and Kariko changed the way mRNA was made by including specific modifications to naturally occurring mRNA that make mRNA safer, more stable, and effective for prophylactic and therapeutic purposes.

Weissman and Kariko received their first COVID-19 shots together at Penn Medicine in December 2020, at a time they called humility and the fulfillment of a lifelong dream of contributing to a discovery to help humanity.

The FDA’s first COVID-19 vaccine approval comes at a critical time in the pandemic, as more contagious and deadly variants continue to spread. According to the World Health Organization, more than 211 million people have been diagnosed with COVID-19 worldwide, and the virus has claimed the lives of more than 4.4 million people.

Weissman and his colleagues are studying mRNA from other infectious disease vaccines, including one for influenza and a unique vaccine that could prevent various types of coronaviruses like COVID-19, SARS and MERS, because even after the pandemic from COVID-19, other coronaviruses will always pose serious threats to public health.

To combat the COVID-19 pandemic which continues to increase in various parts of the world, Weissman and his team are working with Chulalongkorn University in Thailand to help them generate an mRNA vaccine that will be specially dedicated to the prevention of COVID. -19 in middle and low income countries. Aside from infectious diseases, Weissman believes mRNA technology could be the future of protein replacement therapies, immunotherapy, cancer treatments, personalized cancer vaccines, genetic diseases and developmental disease. ‘other drugs.