FLC | BARDA helps facilitate historic Merck-J&J COVID-19 vaccine collaboration

BARDA helps facilitate historic Merck-J&J COVID-19 vaccine collaboration

March 3, 2021

The Biomedical Advanced Research and Development Authority (BARDA) has a key role in the historic manufacturing collaboration between two of the largest U.S. health care and pharmaceutical companies, Merck and Johnson & Johnson (J&J), to expand production of J&J’s COVID-19 vaccine.

The collaboration, announced by President Biden on March 2, will increase manufacturing of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks facing J&J in the production of its vaccine. Janssen Pharmaceuticals, part of J&J, received emergency use authorization from the Food and Drug Administration on February 27 for its COVID-19 vaccine, the third to be authorized for use in the U.S.

“Janssen and BARDA have a history of working together, developing treatments and vaccines for influenza and Ebola," said BARDA Director Gary Disbrow, PhD. "To manufacture their COVID-19 vaccine in the United States, Janssen is working with resources we established after the 2009 influenza pandemic: our Centers for Innovation in Advanced Development and Manufacturing and our fill-finish manufacturing network. With the development of this vaccine, we are seeing the results of years of work on platform technologies and public-private partnerships coming to fruition.”

The U.S. Department of Health and Human Services (HHS) will collaborate with Merck to repurpose some of its existing Merck 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 or to produce Merck products against COVID-19. Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&J’s vaccine.

Consistent with the Administration’s mission to ensure that the United States has sufficient long term sustainable capacity to manufacture vaccines, BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will leverage the Defense Production Act to provide an initial investment of $105 million in funding for Merck, at the administration’s request, to convert, upgrade and equip Merck facilities to the standards necessary to safely manufacture the vaccine. The company will address all the necessary qualification and validation activities needed for the facilities to be used for large-scale manufacturing.

To further accelerate production of the J&J vaccine, President Biden also announced he has invoked the Defense Production Act to expedite materials in vaccine production, such as equipment, machinery and supplies like single use bags, and he has directed the Department of Defense (DOD) to provide daily logistical support to strengthen J&J’s efforts. With the urging and assistance of the Administration, J&J also will begin operating its manufacturing facilities 24/7 to maximize production output.

These efforts will contribute to J&J’s ability to accelerate delivery of their vaccine doses from 100 million doses by the end of June to at or near 100 million doses by the end of May. In the long term, these actions will ultimately double J&J’s U.S. capacity to produce drug substance and increase the U.S. capacity for fill-finish.