Sanofi breaks ground on BARDA-supported fill-finish plant

The plant in Swiftwater, Pennsylvania will provide formulation and filling services and supports the US Government’s strategy to increase domestic production capabilities.

In 2019, Sanofi’s vaccine division won a contract with the US Department of Health and Human Services (HHS) with the Biomedical Advance Research and Development Authority (BARDA) providing $226 million to support pandemic influenza vaccine production.

The contract involved three stages of expansion at the Pennsylvania site to support Sanofi’s adjuvanted recombinant pandemic influenza vaccine. Following the doubling of recombinant influenza vaccine capacity and the retrofitting of a second facility to make adjuvant, Sanofi has now begun the third-phase, breaking ground on a two-story fill-finish facility.

Sanofi’s site in Swiftwater, Pennsylvania. Image c/o Google

“This groundbreaking event marks another significant step in our longstanding relationship with BARDA,” Rakesh Kakkar, US head of Vaccine Manufacturing and Supply at Sanofi said. “Past pandemics confirmed that public-private partnerships are key to providing a relevant and quick answer to pandemic situations.”

The facility falls under BARDA contract 75A50120D00002, which stressed the “critical need to develop domestic suppliers of recombinant, adjuvant, pandemic influenza vaccines.”

According to the 2019 tender, “the manufacturer must maintain production of a FDA licensed recombinant seasonal influenza vaccine,” claiming Sanofi is the only domestic drugmaker that meets these requirements.

“They have a FDA licensed recombinant seasonal influenza vaccine, access to adjuvants (both licensed and in development), and available facilities suitable for renovation.

Sanofi acquired Protein Sciences for $750m in 2017 adding Flublok, a recombinant protein-based influenza vaccine approved by the US Food and Drug Administration (FDA).

The 2019 The latest Sanofi contract was prompted by an executive order issued in September 2019 aimed at driving domestic production with one eye on future pandemics. The US has, obviously, seen a (non-influenza-based) pandemic since and a change of administration, but continues to politically drive an agenda of in-country drug manufacturing as evidenced with President Joe Biden’s Executive Order from last September.