HHS Funds US-Based Monkeypox, Smallpox Vaccine Production
The US Department of Health & Human Services (HHS) will be providing an estimated $11 million in funding to fill and finish manufacturing JYNNEOS, a vaccine approved to prevent smallpox and monkeypox at Grand Reiver Aseptic Manufacturing (GRAM).
Under an agreement between the Biomedical Advance Research and Development Authority (BARDA) and GRAM, the funding will help accelerate the fill and finish manufacturing qualification and production at a new facility in Grand Rapids, Michigan. The new funds will contribute to necessary production equipment purchases, as well as additional staff recruiting and training to operate the line.
BARDA, part of the HHS Administration for Strategic Preparedness and Response (ASPR), placed orders for fill, finish, and delivery of 5 million vials of JYNNEOS from a US government-owned bulk vaccine stored in Denmark. As part of that contract, JYNNEOS’ manufacturer Bavarian Nordic agreed to permit US-based fill and finish production of 2.5 million vials.
"Rapidly increasing the supply and safe delivery of monkeypox vaccine to at-risk Americans is a top priority," said Assistant Secretary for Preparedness and Response Dawn O'Connell. "BARDA's support helps ensure success in doubling the capacity available to fill and finish this vaccine, improves preparedness for smallpox bioterrorism, and strengthens the security of the US supply chain."
JYNNEOS received emergency use authorization from the US Food & Drug administration on August 9, 2022.
Reference:
US Department of Health & Human Services. HHS funs US-based production of smallpox and monkeypox vaccine. August 29, 2022. Accessed August 30, 2022. https://www.hhs.gov/about/news/2022/08/29/hhs-funds-us-based-production-of-smallpox-and-monkeypox-vaccine.html