The US Department of Health and Human Services (HHS) recently awarded four contracts to set up a manufacturing network for the "fill and finish" steps in influenza vaccine production, which the agency said will increase the nation's production capacity by 20%.
Contracts collectively worth $39.8 million were awarded to Cook Pharmica of Bloomington, Ind.; JHP Pharmaceuticals, Parsippany, N.J.; DSM Pharmaceuticals Inc., Greeneville, N.C.; and Nanotherapeutics, Alachua, Fla. The contracts were awarded by HHS's Biomedical Advanced Research and Development Authority (BARDA).
The network is being set up in response to a recommendation made in the Public Health Medical Countermeasures Review in 2010 to create a set of pre-qualified facilities that could fill and finish vaccine for manufacturers in a public health emergency, HHS said in a Sep 25 press release. The countermeasures review was prompted primarily by the delayed delivery of flu vaccine during the H1N1 flu pandemic in 2009.
"No longer will fill and finish manufacturing be the limiting factor in making pandemic influenza vaccines or other products available in a public health emergency," BARDA Director Robin Robinson, PhD, said in the press release.
Together, the four companies will have the capacity to fill and finish 117 million doses of flu vaccine in 12 weeks, according to Elleen Kane, a spokeswoman for HHS's Office of the Assistant Secretary for Preparedness and Response.
Kane told CIDRAP News that HHS's three Centers for Innovation in Advanced Development and Manufacturing (CIADMs) are expected to add production capacity for another 150 million doses in 12 weeks, for a total increase of 267 million doses in 12 weeks. That capacity is in addition to what vaccine manufacturers already have.
Kane said the individual contract amounts for the companies in the network are as follows: Cook Pharmica, $8.7 million; JHP Pharmaceuticals, $7.6 million; DSM Pharmaceuticals, $12.8 million; and Nanotherapeutics, $10.6 million.
The four companies will collaborate with the CIADMs and with the domestic flu vaccine manufacturers, HHS said. The firms also will be available to the agency to help produce small amounts of medical countermeasures for clinical trials.
"Each company in the network will partner with a pandemic influenza vaccine manufacturer to transfer the fill and finish technology into its existing facilities to provide surge capacity for pandemic response," the HHS statement said. "The expanded fill and finish manufacturing network also could provide these core services for manufacturers of drugs and vaccines intended to protect public health against chemical, biological, radiological and nuclear threats."
HHS said the network builds on BARDA's public-private partnership approach for building a national manufacturing infrastructure for medical countermeasures.
Sep 25 HHS press release
Aug 19, 2010, CIDRAP News story on countermeasures review
Jun 18, 2012, HHS press release about CIADMs