By NewsDesk  @bactiman63

Vivaldi Biosciences, a clinical-stage biotechnology company developing genetically engineered intranasal vaccines for viral respiratory diseases, today announced it has filed a provisional patent application with the US Patent and Trademark Office for its Delta-19 combination vaccine for protection against SARS-CoV-2 (the virus responsible for Covid-19) and all strains of influenza virus.

Image/CDC

Simultaneous circulation of SARS-CoV-2 and influenza is a looming public health threat that could cause numerous hospitalizations and deaths, and impose a huge burden on provision of health care, with severe socioeconomic consequences. Delta-19 is a nasal spray vaccine designed to safely provide protection against both SARS-CoV-2 and influenza. Delta-19 also shows the potential to be the first vaccine to provide universal protection against all influenza A and B virus strains, including drifted seasonal influenza strains and emerging strains with pandemic potential.

“We are developing Delta-19 to provide the unprecedented benefit of protection against both Covid-19 and flu. Our Delta-19 program provides the complete package for accelerated development and commercial-scale GMP manufacture, with our clinically-proven vaccine vector technology, and our rapid, high-yield cell-based vaccine manufacturing system,” said William Wick, Chief Executive Officer of Vivaldi.

Vivaldi’s patent application describes compositions and methods of use of a recombinant influenza virus that is safely attenuated, unable to replicate, and expresses key antigenic proteins of SARS-CoV-2 and influenza viruses. Formulated as a vaccine and administered intranasally, the genetically modified virus is designed to generate a broadly protective immune response against both pathogens. Delta-19 rapidly induces the immune signaling protein interferon and IgA antibodies in the nasal passages to neutralize SARS-CoV-2 and influenza viruses at their main point of entry. Interferon generates a self-adjuvant effect that activates CD4+ and CD8+ T cells and antibody-producing B cells for robust systemic immunity.


“Delta-19 builds on Vivaldi’s clinical-stage Delta NS1 vaccine vector technology platform for broadly protective, self-adjuvanting intranasal vaccines. Delta NS1 is a versatile and robust technology platform. We have shown that the Delta NS1 vaccine vector can stably express high levels of foreign proteins and antigens, enabling development of a broad array of prophylactic vaccines for infectious diseases,” said Thomas Muster, PhD, Chief Scientific Officer of Vivaldi.

Influenza causes seasonal epidemics worldwide, leading to millions of cases and hundreds of thousands of deaths each year. Influenza viruses also cause pandemics when a new virus emerges to which humans lack pre-existing immunity. Vaccines are the primary means of preventing influenza infections and their spread, though the effectiveness of available influenza vaccines is limited.

Scientists predict that SARS-CoV-2 will become endemic and adopt a seasonal pattern of annual epidemics, much like influenza. Co-infection of individuals with both influenza and SARS-CoV-2 has been documented. Infection with one virus may make infection with the second virus more severe. Vivaldi’s Delta-19 nasal spray vaccine is designed to address the dual disease threats of Covid-19 and influenza with a superior approach for greater protection against both diseases.