COVID fearmongering has dropped out of the news cycle, but that does not mean that SARS pandemic is over. The WHO has identified the emerging Omicron BA.5., BA4.6, BQ.1, BF.7 and BQ1.1 sublineages as the current variants of concern, with additional variants certainly to evolve. The virus's constant mutations have rendered available vaccines ineffective and left Big Pharma scrambling to adapt. Since the vaccines first became available in 2020, the manufacturers' approach has been to iterate over the rapidly mutating "spike" protein (S-protein) to prime the immune system (i.e., generate antibodies) against the new variants, using either mRNA encoding for the S-protein, or recombinant ("synthetic") S-protein itself. The problem is that the S-protein is highly mutagenic, meaning that the genetic substrate encoding for the protein is prone to changing as the virus propagates through mammalian populations. This rapid evolution means that vaccines are in a perpetual state of "catch up," with the virus clearly pulling ahead.
Clearly, this strategy is not working. A universal, SARS vaccine that is agnostic to S-protein mutation is the only way to get ahead of the pandemic.
BioVaxys believes that they hold the key to developing a universal, “pan-sarbecovirus” vaccine, and have entered into a partnership with The Ohio State University to pursue this endeavor. Their theory is that a previous immune response to the SARS-CoV-1 variant predicts a stronger neutralizing antibody response to subsequent vaccination with a SARS-CoV-2 vaccine. The goal of the partnership is to “stimulate virus cross-reactivity and induce immunity against all or most SARS viruses by immunizing people who have convalesced from a documented SARS-CoV-2 infection or received a full course of any SARS-CoV-2 vaccine, leading to a pan-sarbecovirus vaccine that encompasses current and emerging SARS-CoV-2 variants.”
Researchers recently observed that people who survived the 2002-2003 SARS pandemic who were later administered a COVID-19 vaccine developed an immune response – in a sense a “super immune response” – which cross-reacted with all sarbecoviruses for which they were tested. Sarbecoviruses are a family of viruses that include SARS-CoV-2 and all current ‘Variants of Concern’ such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored by the World Health Organization), SARS-CoV-1, and a broad range of other potentially dangerous zoonotic viruses. In theory, this means those who contracted SARS during the pandemic in the early 2000s and who were vaccinated against COVID-19 are now immune to all sarbecoviruses. BioVaxys concluded that a similar immune response could be generated by immunizing people who have never been vaccinated, or do not have natural immunity, with a haptenized spike protein vaccine for both SARS1 and SARS-Cov-2. Likewise, a similar response would be generated by a haptenized SARS-CoV-1 spike protein “booster” vaccine in people who have been vaccinated for COVID-19, or who have natural immunity. Recently, BioVaxys announced dosing of the first animals with their SARS-CoV-1 vaccine, BVX-1021. Their theory is that administration of their SARS-CoV-1 vaccine (BVX-1021) followed by injection of their SARS-CoV-2 vaccine (BVX-0320) could provide universal immunity to all SARS variants.
On October 17th, The Ohio State University began dosing animals with BVX-1021, with the goal of protecting against all COVID variants when administered in combination with BVX-0320. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS-CoV-2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses. Three weeks post-administration of BVX-1021 in the guinea pig animal model, no toxicities or body weight changes have been observed, nor any injection site reactions.
“Although preclinical results in animal models do not always duplicate in humans, the emerging tolerability and clean toxicity profile are very promising for clinical evaluation.”
The next step of the study is the follow-on immunization of the test animals with BVX-0320, the Company’s Covid-19 vaccine candidate, currently underway at Ohio State. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses. The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response across all sarbecoviruses in those people fully vaccinated for Covid-19, as well as those with natural immunity.
“These interim data further support our efforts to develop a safe and well-tolerated solution for sarbecoviruses such as SARS-1, SARS-CoV-2, and its continuously emerging variants. The emerging in vivo safety and tolerability profile of BVX-1021 mirrors that shown by our SARS-CoV-2 vaccine, BVX-0320, and is further evidence of the viability of our haptenized antigen vaccine platform across different viruses.”
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