U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Milestones :: Perspectives :: Research

 

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

:: COVID Data Tracker Friday, March 6, 2021

 

White House [U.S.]
Briefing Room
Fact Sheet: The U.S. Response to Ebola Outbreaks in West and East Africa
March 05, 2021 • Statements and Releases

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 05, 2021 • Press Briefings

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 03, 2021 • Press Briefings

Remarks by President Biden on the Administration’s COVID-19 Vaccination Efforts
March 02, 2021 • Speeches and Remarks

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 01, 2021 • Press Briefings

Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines
President Biden Invokes Defense Production Act to Support Measures to Accelerate Vaccine Development
March 2, 2021
President Biden announced today that his Administration has helped forge a 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 will increase manufacture 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.

 

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, the Biomedical Advanced Research and Development Authority (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.