Sanofi Pasteur, parent company of Meriden-based Protein Sciences, has agreed to manufacture the Pfizer BioNTech vaccine after clinical trials of its own vaccine were delayed in December, the company announced this week.
Sanofi will provide BioNTech access to its infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt, Germany in the summer of 2021, according to a company statement.
“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved,” Sanofi CEO Paul Hudson said. “Today’s announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic. We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so.”
In the meantime, Sanofi’s North American base will continue to prioritize developing two other vaccines; one that draws on recombinant protein technology developed by Protein Sciences on Research Parkway in Meriden, and another mRNA vaccine.
Sanofi is collaborating with GlaxoSmithKline or GSK on the COVID-19 vaccine candidate. The vaccine shares the same technology as FluBlok, which was developed in Meriden.
GSK is providing the established pandemic adjuvent platform. Adjuvents are additives to boost the immune response to the vaccine and lower the amount of antigen required. The federal Biomedical Advanced Research and Development Authority or BARDA funded $2.1 billion to Sanofi in August for vaccine development in Meriden and at sites in Paris and Pennsylvania. Sanofi Pasteur bought Protein Sciences in 2017 for $750 million.
However, Phase 1 and 2 study results this fall showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen, according to the company.
The setback delayed vaccine development by more than half a year.
“We care greatly about public health which is why we are disappointed by the delay, but all our decisions are and will always be driven by science and data,” Sanofi’s Executive Vice President Thomas Triomphe said in December. “We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”
Sanofi’s recombinant technology gives its vaccine stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission, the company said in a statement. In a study of non-human primates the vaccine could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs within 2 to 4 days.
Sanofi plans to initiate a new Phase 2 study in February 2021 with support from BARDA. If the data is positive, a global Phase 3 study could start in the second quarter of 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with potential availability of doses in late fall 2021.
Sanofi is also developing an mRNA vaccine with Translate Bio that is similar to the Pfizer and Moderna vaccines currently in distribution.
Preclinical data show that two immunizations of Sanofi’s mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.
The locations of the clinical trials were not disclosed.