A messenger RNA combination vaccine that Pfizer and BioNTech are developing for both Covid-19 and influenza posted mixed results in a pivotal study, meeting just one of the two main goals assessing the shot’s ability to trigger an immune response, the companies announced Friday.
The vaccine combination pairs an experimental mRNA-based influenza vaccine candidate with Comirnaty, the FDA-approved Pfizer and BioNTech mRNA Covid-19 vaccine. The Phase 3 study enrolled more than 8,000 adults ages 18 to 64, randomly assigned to receive either the experimental combination vaccine or a licensed influenza vaccine and Comirnaty given in the same visit.
Without providing specific figures, the companies said the combination vaccine elicited “robust responses” to influenza A. But against the influenza B strain, the combination vaccine showed lower marks on measures of antibody response. In Covid-19, response to the combination vaccine was comparable to Comirnaty.
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No safety signals were reported for the combination vaccine. Pfizer and BioNTech said they are evaluating adjustments to the combination vaccine to improve immune responses against influenza B and will discuss with regulators the best way to proceed.
“We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this,” Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said in a prepared statement. “Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination Covid-19 and influenza program, for which we are evaluating the next steps.”
The two types of influenza that cause seasonal disease are influenza A and influenza B. Of the two, influenza B is less common. Influenza B has been a tough target for vaccine developers. Last year, an experimental Moderna mRNA vaccine posted positive data against influenza A but disappointing results against influenza B. However, in June, Moderna reported preliminary data showing its experimental flu and Covid-19 combination vaccine met the main goal of a Phase 3 test, including positive marks against both influenza A and influenza B.
Meanwhile, an experimental mRNA influenza vaccine developed by partners CureVac and GSK posted preliminary Phase 2 data in April showing it did not beat comparator vaccines. This seasonal flu vaccine is now in the hands of GSK, which last month agreed to pay CureVac €400 million (about $431 million) to acquire that program, a Covid-19 vaccine, and an avian influenza vaccine.
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{The following two paragraphs added with analyst comments.} In a note sent to investors Friday, William Blair analyst Myles Minter said the disappointing trial result for Pfizer and BioNTech gives Moderna the clear lead in developing an mRNA flu/Covid-19 combination vaccine. Even if the partners are successful in tweaking their combo vaccine and running another clinical trial as Moderna did, that work could put them about eight months behind. But Minter isn’t writing off the Pfizer and BioNTech combo vaccine.
“However, considering the modularity and flexibility of mRNA vaccines, combined with the relatively short trials required to demonstrate immunogenicity and gain accelerated approval, we are not ready to rule out BioNTech/Pfizer from a competitive standpoint, and they remain a material competitive threat in the commercial vaccine space given ex-U.S. Covid-19 market dynamics and contracting,” Minter wrote.
Pfizer has other standalone influenza programs still in development. The pharmaceutical giant previously reported positive preliminary Phase 3 results for a first-generation quadrivalent mRNA flu vaccine tested in adults ages 18 to 64. However, this vaccine did not meet efficacy goals in adults age 65 and older. Pfizer then developed second-generation influenza vaccines intended to offer a better immune response and breadth of protection. These programs include new trivalent influenza mRNA vaccine candidates. Pfizer said a Phase 2 test of these second-generation influenza vaccines demonstrated robust influenza A and B responses. The company added that data in participants age 65 and older will become available at a later date.