Lessons from COVID: URMC, RGH Launch Clinical Trials to Test mRNA Flu Vaccine

Sep. 2, 2021

Taking a page from the COVID playbook, Pfizer and BioNTech are adapting the technology from their highly successful COVID vaccine to prevent seasonal flu. Both the University of Rochester Medical Center and Rochester General Hospital are taking part in the phase 1 clinical trial to test Pfizer and BioNTech’s mRNA flu vaccine.

The World Health Organization estimates that three to five million people worldwide come down with severe cases of seasonal flu each year, and unfortunately between 290,000 and 650,000 of them do not survive the infection. Though flu shots have been around for nearly a century, they are typically only 40 to 60 percent effective and have not had a technology upgrade in quite some time.

“If we could produce a flu vaccine that is as effective as the COVID vaccines are, it would be a game-changer,” said Ann Falsey, M.D., professor of Infectious Diseases and co-director of the Vaccine and Treatment Evaluation Unit at URMC. “Even just a small increase in efficacy could mean thousands of lives saved.”

Current flu vaccines take a long time to produce, but the flu virus mutates quickly. By the time a flu vaccine is tested, produced and distributed, the flu strain it targets may no longer be circulating and new strains may evade the vaccine.

That’s where scientists hope the semi-new mRNA vaccine platform could help. mRNA vaccines deliver short snippets of a virus’s genetic material, called mRNA, to get host cells to make a small, harmless portion of the virus to induce an immune response. The best part: mRNA vaccines can be produced very quickly and can easily be tweaked to target new virus strains.

Though mRNA vaccines have been studied for decades, Pfizer’s highly effective COVID vaccine was the first mRNA vaccine to be approved for use in humans by the U.S. Food and Drug Administration.

“Based on what we've seen with COVID, mRNA appears like it may be a better vaccine strategy,” said Angela Branche, M.D., assistant professor of Infectious Diseases and co-director of the Vaccine and Treatment Evaluation Unit at URMC, “not only because the COVID mRNA vaccines were 95 percent effective, but because they might allow us to give people flu shots that protect against strains that are currently circulating.”

URMC and RGH are two of 12 sites testing Pfizer and BioNTech’s new mRNA flu vaccine.  Phase 1 of the clinical trial will determine whether the mRNA flu vaccine is safe, whether it induces a robust immune response, and at which dose.

The phase 1 study will enroll 350 healthy adult volunteers age 65-85 across all 12 sites, with approximately 50 enrolling at the URMC and RGH sites. All volunteers will receive a single dose of the experimental flu vaccine and will have four follow-up blood draws over two months.

“There is concern about a resurgence of the other usual wintertime viruses, such as flu and respiratory syncytial virus (RSV), on top of COVID this fall,” said Edward E. Walsh, M.D., professor of Infectious Diseases at URMC and head of Infectious Diseases at Rochester General Hospital. “That could overwhelm healthcare systems and lead to more deaths. That’s why it’s so important to vaccinate people not just against COVID, but also flu and RSV.”

Coincidentally, Walsh will soon also take part in an RSV vaccine trial. RSV, which causes mild, cold-like symptoms in most people, can be very serious in both infants and older adults. According to the Centers for Disease Control and Prevention, each year 177,000 older adults are hospitalized with RSV infections in the U.S. and 14,000 of them die.

Visit to sign up to participate in the flu vaccine trial and check it frequently for more information about the upcoming RSV study.