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Taking a page from the COVID playbook, Pfizer and BioNTech are adapting their highly successful COVID vaccine technology to prevent seasonal flu. The University of Rochester Medical Center and Rochester General Hospital are both participating in the Phase 1 clinical trial to test the mRNA influenza vaccine from Pfizer and BioNTech.

The World Health Organization estimates that three to five million people worldwide contract severe cases of seasonal influenza each year, and unfortunately between 290,000 and 650,000 do not survive the infection. Although influenza vaccines have been around for almost a century, they are generally only 40-60% effective and have not enjoyed a technology upgrade for some time.

“If we could produce an influenza vaccine as effective as COVID vaccines, that would be a game-changer,” said Ann Falsey, MD, professor of infectious diseases and co-director of the Vaccine and Treatment Assessment Unit at the ‘URMC. . “Even a small increase in efficiency could mean thousands of lives saved. “

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

This is where scientists hope the semi-new mRNA vaccine platform could help. MRNA vaccines provide short extracts of the genetic material of a virus, called mRNA, to cause host cells to make a small, harmless part of the virus to induce an immune response. The best part: mRNA vaccines can be produced very quickly and can easily be modified to target new viral strains.

Although 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 United States Food and Drug Administration.

“Based on what we’ve seen with COVID, mRNA appears to be a better vaccine strategy,” said Angela Branche, MD, assistant professor of infectious diseases and co-director of the vaccine and treatment evaluation unit. to the URMC, “not just because the COVID mRNA vaccines were 95% effective, but because they could allow us to vaccinate people against the flu that protect them from the strains that are currently circulating.

URMC and RGH are two of 12 sites testing the new mRNA influenza vaccine from Pfizer and BioNTech. The phase 1 clinical trial will determine if the mRNA influenza vaccine is safe, if it induces a robust immune response, and at what dose.

The phase 1 study will recruit 350 healthy adult volunteers aged 65 to 85 at the 12 sites, including around 50 at the URMC and RGH sites. All volunteers will receive a single dose of the experimental influenza vaccine and undergo four follow-up blood samples over two months.

“There is concern about a resurgence of other usual winter viruses, such as influenza and respiratory syncytial virus (RSV), in addition to COVID this fall,” said Edward E. Walsh, MD, professor of infectious diseases at URMC and Head of Infectious Diseases at Rochester General Hospital. “It could overwhelm health systems and lead to more deaths. This is why it is so important to vaccinate people not only against COVID, but also against influenza and RSV. “

Coincidentally, Walsh will soon be participating in an RSV vaccine trial as well. RSV, which causes mild cold-like symptoms in most people, can be very serious in infants and the elderly. According to the Centers for Disease Control and Prevention, every year 177,000 older people are hospitalized with RSV infections in the United States and 14,000 of them die.

Visit Flu.urmc.edu to register to participate in the influenza vaccine trial and check back frequently for more information on the upcoming RSV study.