Vaccine Updates: Two Announcements From Pfizer

On October 26, Pfizer and BioNTech released positive top-line data for their mRNA-based combination vaccine that targets influenza and COVID-19. The clinical trial compared the vaccine candidates to a licensed influenza vaccine and an adapted COVID-19 vaccine. The lead formulations showed strong immune responses to influenza A, influenza B, and SARS-CoV-2 strains.

The Flu and COVID-19 follow a seasonal pattern, with increased risk in the fall and winter. Co-infections and consecutive respiratory infections can amplify the risk of severe illness and hospitalizations, particularly among high-risk groups.

“Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness,” Ugur Sahin, M.D., CEO and Co-founder of BioNTech, stated in the press release.

The combination formulations evaluated in the Phase 1/2 trial had a safety profile similar to the COVID-19 vaccine. The levels of antibodies produced in response to the lead formulations were comparable to those seen with approved flu and COVID-19 vaccines. Specifically, when comparing the vaccine candidates to the flu vaccine, the levels of antibodies produced were higher than what is seen with the licensed quadrivalent influenza vaccine.

A Phase 3 clinical trial for the lead formulations is expected to commence in the near future. The Pfizer-BioNTech mRNA-based combination vaccine for influenza and COVID-19 has received Fast Track Designation from the FDA.

Data from the Phase 1/2 trial has not yet been published in a peer-reviewed journal.

Also, on October 20, Pfizer announced FDA approval of Penbraya, a pentavalent vaccine that covers the most common serogroups causing meningococcal disease in adolescents and young adults ages 10-25.

Penbraya combines components from two other vaccines, Trumenba and Nimenrix, to protect against the five most common serogroups of meningococcal bacteria causing invasive meningococcal disease worldwide. Penbraya is given as a two-dose series, administered six months apart.

Meningococcal disease is a rare but serious illness that can be fatal within 24 hours. It can also cause long-term disabilities for those who survive.

The FDA’s decision is based on the positive results from the Phase 2 and Phase 3 trials assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial included more than 2,400 participants from the U.S. and Europe.

Penbraya reduces the number of doses needed to be fully vaccinated against the most common serogroups. This makes the vaccination process more efficient and may increase vaccination rates among adolescents and young adults. Penbraya could also potentially decrease the number of meningococcal disease cases, lower mortality rates, and reduce the long-term consequences and costs associated with meningitis outbreaks.