MERIDEN — The U.S. Department of Health and Human Services will provide up to $2.1 billion to vaccine makers Sanofi Pasteur and GSK to fast-track the development and manufacturing of 100 million doses of a vaccine against COVID-19.
Sanofi’s recombinant protein-based vaccine draws on technology developed at Protein Sciences on Research Parkway to produce its signature influenza vaccine — Flublok. The funding will allow Sanofi to begin small-scale trials in the fall, and coordinate with GSK’s vaccine manufacturing capabilities in the U.S.
The award is similar to a $2 billion grant to Pfizer in Groton to fast-track its vaccine development in a U.S. government initiative known as “Operation Warp Speed.”
Sanofi bought Protein Sciences on Research Parkway and its vaccine technology in 2017. In addition to Flublok, the company had already developed a SARS vaccine that used similar technology as the COVID-19 vaccine, company officials said.
Gov. Ned Lamont visited Protein Sciences in March to praise the company’s vaccine development.
Lamont said the company is “ideally suited” to research a coronavirus vaccine because it has previously been on the “frontline” of developing a vaccine for severe acute respiratory syndrome, or SARS. Sanofi Pasteur, the global business unit of Sanofi, will use previous work for the SARS vaccine developed by Protein Sciences to help develop a COVID-19 vaccine, Sanofi announced last month.
The governor cautioned that development may take some time during his visit back in March.
“Look, you can’t rush these things,” Lamont said. “I know that we all think, ‘Oh boy, maybe this is going to save the day for us.’ COVID-19 is expanding very quickly.”
At the time, Protein Sciences officials said their scientists in Meriden had been working for the past several weeks on a possible COVID-19 vaccine they hoped would be ready for clinical trials by the end of the year. The company has about 100 employees at the Research Parkway site and some manufacturing capacity.
Sanofi expects a Phase 1 study to start by the end of the year, and, if the data is positive, an approval at the earliest in the second half of 2021. Sanofi expects to be able to supply 90 to 360 million doses annually, according to a press statement announcing the award.
Sanofi will receive the majority of the U.S. government funding, and maintains an option to supply an additional 500 million doses.
“The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone,” said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur. “From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the U.S. Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale.”
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said U.S. Health and Human Services Secretary Alex Azar. “Today’s investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
If the data is positive, the companies can request U.S. regulatory approval in the first half of 2021.