Merck to Manufacture J&J Vaccine

BioPharm International Editors

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

Merck (known as MSD outside the United States and Canada) will receive up to $268 million from the Biomedical Advanced Research and Development Authority (BARDA), US Department of Health and Human Services, to adapt and make available some of the company’s manufacturing facilities for the production of COVID-19 vaccines and medicines.

On March 2, 2021, the company announced multiple agreements with BARDA and Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), to support the manufacturing and supply of J&J’s single-dose COVID-19 vaccine. Merck will produce drug substance, formulate, and fill vials of the vaccine at US facilities.

The Biden Administration invoked the Defense Production Act to equip the Merck facilities for this “historic manufacturing partnership” of two pharmaceutical giants, a White House spokesperson said.

“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, Human Health at Merck, in the press statement. “This funding from BARDA will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much needed medicines and vaccines for the pandemic.”

“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, in the statement.

The Janssen COVID-19 vaccine received Emergency Use Authorization from FDA on Feb. 27, 2021 and initial supplies of vaccines shipped on March 1, 2021.

In January 2021, Merck discontinued development of two COVID-19 vaccine candidates, when studies showed the immune response was inferior to levels following natural infection. The company announced plans to focus research and production capabilities on two COVID-19 therapeutic candidates.

Source: Merck