Stopping the spread: Federal investment boosts Meriden facility’s search for vaccine

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MERIDEN — The federal government’s investment of up to $4 billion in two Connecticut companies to test and manufacture vaccine is part of a national race to stop the spread of COVID-19.

The Biomedical Advanced Research and Development Authority last week announced up to $2.1 billion in funding for Sanofi and GSK to develop, test and manufacture up to a million doses of vaccine. The allocation follows a similar funding commitment of up to $1.95 billion to Pfizer in Groton.

"We’re pleased to be included in operation Warp Speed,” said Clement Lewin, head of Sanofi’s BARDA office. “We have a 15 year partnership with BARDA and we’re pleased to be included in the program. This is truly a global effort.”

Product development comes from a collaboration of Sanofi sites, including Protein Sciences in Meriden, Pennsylvania and France.

“Meriden is playing a key role because they are making the material for our non-clinical studies,” Lewin said, “and the materials we use in our phase one studies.” 

Sanofi expects to enroll, like other companies in the vaccine race, about 30,000 people for its clinical trials but the locations are currently undisclosed. 

Sanofi is part of a network strategy recently developed by the National Institute of Allergy and Infectious Diseases to coordinate and consolidate COVID-19 research and testing data. The network will collaborate on resources and help screen and enroll the thousands of volunteers needed to test the new vaccine,  Dr. Anthony Fauci told Connecticut reporters Monday during a press conference with Gov. Ned Lamont. 

Paulo H. Verardi, Ph.D., associate professor of virology and vaccinology at UConn, said the speed of development and testing is unusual but understandable because of the public health and economic harm caused by the pandemic. 

”The situation is different right now. There’s a lot of public pressure,” Verardi said. “A big majority want to consider this vaccine sooner rather than later. You have to think a little outside the box, which is one reason why the government is being more proactive.”

As of today, only Moderna in Cambridge, Massachusetts is actively recruiting volunteers for a NIAID study. Sanofi expects to begin phase one and phase two in the fall and conduct phase three trials in late 2020 or early 2021. Its licensed vaccine could come in the second half of 2021. 

“Having a safe and effective medical countermeasure to prevent COVID-19 would enable us to not only save lives but also help end the global pandemic,” Fauci stated when announcing the network. “Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against COVID-19.”

The network is critical to ensure vaccine testing is spread through geographical regions to determine effectiveness. For instance, now is not a good time to test a vaccine in Connecticut because the state’s infection rate is so low, Verardi said. 

But any network’s effectiveness depends on the “accuracy and trustworthiness of the information network partners are willing to share with each other,” said David Souder, associate professor of strategic management at the University of Connecticut School of Business. 

"It appears that there is at least some willingness to make the licensing process adapt to the uniqueness of the current situation,” Souder said. “Long-term benefits for Connecticut’s economy are a possibility but we won’t know for a while, because it will depend on the eventual success of the products under development.”

Members of the bio-medical community lauded the state’s role in the development of such a critical vaccine.

Protein Sciences spent more than a decade getting FDA approval for its non-egg technology used to make the influenza vaccine Flublok. The same technology was used in a SARS vaccine that never made it to the U.S. market. Protein Sciences and its global partners have used its platform to make vaccines in the fight against Ebola, H1N1 and Zika. The company of 100-employees has manufacturing facilities on Research Parkway and in Pearl River, New York.

The protein-based platform was attractive to Sanofi Pastuer, which purchased Protein Sciences in 2017.

"Sanofi's investment highlights the recognition of the talent within Protein Sciences and their non-egg based vaccine technology,”  said Dawn Hocevar, president and CEO of BioCT, in an e-mail. “The BioCT community is very proud of Protein Sciences’ accomplishments.  Their work is very promising and it is very exciting to have potential COVID vaccines designed within Connecticut.”

Local officials are pleased with the government’s investment to support a local company in its efforts to stop the spread of COVID-19. 

"This partnership between the U.S. government and Sanofi illustrates how vital Protein Sciences is, not only to Meriden and our economy, but to the United States and the overall health and safety of Americans across the country,” Mayor Kevin Scarpati said.



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