The Biden administration helped forge a deal between Merck and Johnson & Johnson (J&J) to expand production of J&J’s COVID-19 vaccine, which is expected to help the company deliver 100 million doses by the end of May instead of its previous June goal.
The collaboration between the two pharmaceutical giants will increase manufacturing capabilities for the vaccine as well as its fill-finish capacity. Through this arrangement, the U.S. Department of Health and Human Services (HHS) will work with Merck to repurpose some of its existing facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies, including the current pandemic. The facilities will be available to private sector partners working with the federal government on the COVID-19 response.
Janssen Pharmaceuticals, part of J&J, will be the first federal partner to use repurposed Merck facilities to manufacture its COVID-19 vaccine, recently authorized by the U.S. Food and Drug Administration. Merck will use two of its facilities to help produce and fill vials of J&J’s vaccine.
“We are steadfast in our commitment to contribute to the global response to the pandemic as part of the remarkable efforts of the entire medical and scientific community,” said Mike Nally, executive vice president of Human Health at Merck.
Further, the Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, will provide an initial investment of $105 million in funding for Merck through the Defense Production Act. The money will be used to upgrade and equip Merck facilities to the standards necessary to safely manufacture the vaccine.
“At Merck, we have a rich legacy in vaccine manufacturing and look forward to combining our expertise with Johnson & Johnson to help increase supply and expand access to authorized SARS-CoV-2/COVID-19 vaccines,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division.
Global life sciences company and vaccine manufacturer Emergent BioSolutions welcomed the news of Johnson & Johnson’s collaboration with Merck.
Since April 2020, Emergent has served as a contract development and manufacturing (CDMO) collaborator to provide global drug substance manufacturing of Johnson & Johnson’s COVID-19 vaccine. Emergent has been producing drug substance for Janssen at large scale at Emergent’s Baltimore Bayview facility. Drug substance is the active pharmaceutical ingredient for the vaccine, which is then shipped to other supply chain collaborators to be filled and finished in vials before distribution.
“We’re all in this together. In the fight against COVID-19 there are no competitors, only allies. Merck will be a great collaborator and we’re excited to work with them to further increase the supply of this vaccine for patients globally,” Robert G. Kramer, president & CEO of Emergent BioSolutions, said on Wednesday. “Through public and private investment, Emergent has built a production infrastructure capable of producing more than a billion vaccine doses annually.”
Noting the complexities of vaccine manufacturing, Emergent explained that all of the manufacturing technology, processes, and production equipment had to be developed and put in place concurrently with the clinical development of the COVID-19 vaccine, occurring in a matter of months rather than the years it usually takes. “Parallel and rapid technology transfer to manufacture at this scale has never been done before,” added Kramer.
Meanwhile, President Joe Biden invoked the Defense Production Act to expedite materials in vaccine production, such as equipment, machinery, and supplies like single-use bags. Also, Biden has directed the Department of Defense to provide daily logistical support to strengthen J&J’s efforts. J&J will begin operating its manufacturing facilities 24/7 to maximize production output.