Post by Nadica (She/Her) on Aug 17, 2024 0:18:41 GMT
Pfizer, BioNtech say combined flu-COVID vaccine misses a main goal of Phase 3 trial - Published Aug 16, 2024
Pfizer (PFE.N), opens new tab and BioNTech (22UAy.DE), opens new tab said a late-stage trial of their experimental mRNA vaccine to protect against influenza and COVID-19 found the combination shot failed to meet one of the study's two main goals and they are evaluating next steps.
The drugmakers said on Friday the Phase 3 trial showed the vaccine elicited a robust influenza A immune response, compared to a standard flu vaccine, but showed weaker results against the influenza B strain.
The formulation showed similar responses against SARS-CoV-2 as the companies' COVID-19 vaccine.
"We remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps," Annaliesa Anderson, Pfizer's head of vaccine research and development, said in a statement.
The companies said they are discussing the findings with health authorities and evaluating adjustments to the candidate.
The trial, which compared the experimental vaccine to a licensed influenza vaccine and the companies' COVID-19 vaccine given at the same visit, enrolled 8,000 healthy adults.
The drugmakers said no safety issues with the combination vaccine have been identified.
Pfizer also said a Phase 2 trial of its second-generation mRNA flu vaccine candidate showed that the formulation elicited robust influenza A and B responses, with no safety issues reported.
It said data from the 450-patient flu vaccine trial would be made available at a later date.
Pfizer (PFE.N), opens new tab and BioNTech (22UAy.DE), opens new tab said a late-stage trial of their experimental mRNA vaccine to protect against influenza and COVID-19 found the combination shot failed to meet one of the study's two main goals and they are evaluating next steps.
The drugmakers said on Friday the Phase 3 trial showed the vaccine elicited a robust influenza A immune response, compared to a standard flu vaccine, but showed weaker results against the influenza B strain.
The formulation showed similar responses against SARS-CoV-2 as the companies' COVID-19 vaccine.
"We remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps," Annaliesa Anderson, Pfizer's head of vaccine research and development, said in a statement.
The companies said they are discussing the findings with health authorities and evaluating adjustments to the candidate.
The trial, which compared the experimental vaccine to a licensed influenza vaccine and the companies' COVID-19 vaccine given at the same visit, enrolled 8,000 healthy adults.
The drugmakers said no safety issues with the combination vaccine have been identified.
Pfizer also said a Phase 2 trial of its second-generation mRNA flu vaccine candidate showed that the formulation elicited robust influenza A and B responses, with no safety issues reported.
It said data from the 450-patient flu vaccine trial would be made available at a later date.