Novavax and Par Sterile Products Enter into Fill/Finish Manufacturing and Services Agreement for COVID-19 Vaccine Candidate

September 28, 2020

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

Novavax and Par Sterile Products, a subsidiary of Endo International, announced on Sept. 25, 2020 that they have entered into a non-exclusive agreement under which Par Sterile will provide fill/finish manufacturing services for Novavax's COVID-19 vaccine candidate, NVX-CoV2373, at Par Sterile’s plant in Rochester, MI.

Through the agreement, Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US, a Par Sterile press release said.

"This agreement puts an important piece in place as we finalize our supply chain for the US clinical trial and eventually, commercial distribution of NVX-CoV2373, our nanoparticle vaccine adjuvanted with Matrix-M," said Stanley C. Erck, president and CEO, Novavax, in the press release. "Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon."

"We are very pleased to help bring Novavax' COVID-19 vaccine to the public," said Blaise Coleman, president and CEO of Endo, in the press release. "Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the US market and we are proud to partner with Novavax on such a critical initiative. This partnership further underscores Endo's commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies."

Source: Par Sterile