Pfizer and BioNTech are currently developing a combination mRNA vaccine targeting both COVID-19 and influenza, which has shown mixed outcomes in a key clinical trial. The study’s results met only one of the two primary objectives for demonstrating the vaccine’s ability to initiate an immune response, according to an announcement made by the companies on Friday.
The combined vaccine incorporates an experimental mRNA-based influenza vaccine with Comirnaty, Pfizer and BioNTech’s FDA-approved mRNA COVID-19 vaccine. The Phase 3 clinical trial involved over 8,000 adults aged 18 to 64, who were randomly assigned to receive either the combination vaccine or separately administered licensed flu vaccine and Comirnaty in a single visit.
The companies refrained from providing specific details but noted that the combination vaccine prompted “robust responses” against influenza A. However, the performance was weaker against the influenza B strain, as indicated by lower antibody response levels. As for COVID-19, the immune response to the combination vaccine was similar to that observed with Comirnaty alone. The trial did not report any safety concerns regarding the combination vaccine.
In response to these results, Pfizer and BioNTech stated they are considering changes to enhance the immune effectiveness against influenza B and plan to consult with regulatory authorities to determine the best path forward. Annaliesa Anderson, Pfizer’s senior vice president and head of vaccine R&D, emphasized the company’s commitment to reducing the burden of respiratory diseases through efficient combination vaccines. She expressed optimism about the future of the combination vaccine program, indicating that the companies are contemplating next steps.
Influenza A and B are the main viruses that cause seasonal flu, with influenza B typically being less prevalent yet more challenging for vaccine development. An experimental mRNA vaccine by Moderna demonstrated positive outcomes against influenza A but unsatisfactory results for B last year, although more recent updates in June showed improvement, meeting main goals in Phase 3 tests for both strains. This points to ongoing difficulties and progress in targeting influenza B across various research programs.
Contrastingly, an mRNA flu vaccine developed by CureVac and GSK underperformed in preliminary Phase 2 trial results compared to other vaccines. This vaccine is now managed by GSK after a recent acquisition deal involving payments of approximately €400 million to CureVac for this program, a COVID-19 vaccine, and an avian flu vaccine initiative.
Besides the combination vaccine, Pfizer has other standalone influenza vaccine projects in the pipeline. The company previously reported encouraging early Phase 3 outcomes for a first-generation quadrivalent mRNA flu vaccine aimed at adults aged 18 to 64, although it fell short in efficacy among those aged 65 and older. Pfizer is also developing second-generation mRNA influenza vaccines, including new trivalent versions, which have shown promising immune responses against both influenza A and B in a Phase 2 trial. Further data, particularly involving older adults, is expected to be released later.
This ongoing research reflects the broader pharmaceutical industry’s efforts in leveraging mRNA technology, initially popularized by the rapid development of COVID-19 vaccines, to tackle other prevalent respiratory viruses such as influenza. The success of these initiatives could potentially transform the future landscape of vaccine development and disease prevention.
#Pfizer #BioNTech #Flu #Covid19 #Combo #Vaccine #Falls #Short #Influenza #Strain
