BiondVax Pharmaceuticals has announced that an independent study reveals that its universal flu vaccine (M-001) shows effective immunogenicity against H3N2 influenza, which caused the 2015 flu epidemic in the US.
The Israeli company says statistical analysis of results from a 2012 study demonstrate that BiondVax’s universal flu vaccine, administered in the BVX-005 phase II trial, provided participants with increased immunogenicity against future strains which did not exist at the time of the study—including the newly emerged H3N2 influenza strain.
“We are happy that the participants [who] received our vaccine in the trial three years ago present a higher immunogenicity, even to actual flu strains in circulation now,” said Ron Babecoff, BiondVax’s President and CEO. “The independently provided statistical analysis we reported today is very important as it demonstrates that M-001 provides a safety net by broadening the immunogenicity to existing and future flu strains – in this case, against a specific flu strain that back when the trial was conducted, did not yet exist.”
In 2012, 120 elderly participants aged 65 or over, participated in the BVX-005 trial. In 2015, BiondVax exposed the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist.
BiondVax examined the immunogenicity (HAI) antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group.
“If our vaccine was approved by the necessary regulatory bodies and available in the market during the last winter, we believe that the recent epidemic could have been prevented. These results are another important data point showing the importance of our work for global public health and in particular for the elderly which are most vulnerable to this dangerous virus,” said Babecoff, of his biopharmaceutical company’s universal flu vaccine that is designed to provide multi-season and multi-strain protection against most human influenza virus strains.