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Ep. 2: From Promise to Progress: Universal Influenza Vaccines

In the second episode of the Flu Vaccine Forum, Dr. Diane Post moderates a conversation with Dr. Norman Baylor, Dr. Scott Hensley and Dr. Amin Khan. Together they define regulatory roadblocks facing universal influenza vaccine candidates and explore potential solutions.

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Flu Vaccine Forum Episode 2 Livestream

A game-changing universal influenza vaccine (UIV) candidate arrives—What’s next? As next-generation and broadly protective influenza vaccine candidates with promising pre-clinical and clinical data continue to emerge, such as the University of Pennsylvania’s multivalent mRNA influenza vaccine candidate, now is the time to address the regulatory roadblocks that obstruct the path to approval and deployment.

Dr. Diane Post, Chief, Viral Respiratory Diseases Section, DMID/NIAID/NIH, led experts in a rich conversation to define these regulatory challenges for licensure, identify new correlates of protection, and demonstrate efficacy. Panelists included:

  • Dr. Norman Baylor, Trustee, Sabin Vaccine Institute and Former Director of FDA’s Office of Vaccines Research and Review
  • Dr. Scott Hensley, Professor of Microbiology at the University of Pennsylvania and Director of Penn-CEIRR
  • Dr. Amin Khan, Chief Science Advisor, mRNA Hub Programme, Afrigen Biologics & Vaccines

As in Flu Vaccine Forum’s Episode 1, the panelists for Episode 2 once again herald the urgent need for a next generation, more broadly protective influenza vaccine to be approved and deployed before the next pandemic strain emerges, and the importance of investing in influenza vaccine research and development today, to avoid the influenza pandemic of tomorrow.

The multivalent mRNA influenza vaccine candidate developed by Scott Hensley, Drew Weissman and colleagues at the University of Pennsylvania, shows promise towards reaching this goal. This vaccine candidate, which encodes hemagglutinin antigens from all 20 known subtypes of influenza virus, was shown in animal trials to elicit strong antibody responses to each of the encoded antigens and protect mice and ferrets in challenge trials of matched and mismatched strains. In this episode, Dr. Scott Hensley kicks off the conversation by profiling the UPenn candidate, describing its current development status and plans for the future.

Pfizer, Moderna, Sanofi, GSK and Novavax have also made strides in the development of next-generation seasonal influenza vaccines—all of which have proceeded to human trials. What all of these vaccine candidates have in common is a daunting and uncertain pathway ahead to reach the finish line that is regulatory review and approval. Given the promise shown by the UPenn vaccine candidate and other broadly protective influenza vaccine candidates in preclinical research, as well as the abundance of next-generation seasonal influenza candidate vaccines, it’s time to address regulatory barriers facing innovative influenza vaccine development.

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