Merck to Manufacture Johnson & Johnson COVID-19 Vaccine for US

March 10, 2021 - The Biden Administration recently announced a historic collaboration between Johnson & Johnson and Merck to expand production of Johnson & Johnson’s COVID-19 vaccine, Ad26.COV2.S. 

The collaboration will boost the manufacturing of vaccine drug substance and its fill-finish capacity, which are two of the greatest challenges that Johnson & Johnson has faced during the production of Ad26.COV2.S. 

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, the agency said in the announcement.

Merck will use two of its facilities to produce drug substance, formulate, and fill vials of Johnson & Johnson’s vaccine.

Additionally, the facilities will be available to private sector partners working with the federal government on the COVID-19 response or to product Merck products against the coronavirus, HHS explained. 

Janssen Pharmaceuticals, the subsidiary of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. 

Since January 2020, Johnson & Johnson has been working directly with HHS, health authorities, and other top pharmaceutical companies to help combat the pandemic.  

“We are pleased to collaborate with Merck as part of our global network to manufacture our COVID-19 vaccine. Merck has a long history of vaccine expertise, and we expect this manufacturing arrangement will enhance our production capacity so that we can supply beyond our current commitments,” Johnson & Johnson said in an official statement after the collaboration announcement. 

“Merck is the ninth manufacturer to join our global network and this significant collaboration will further enable us to deliver our COVID-19 vaccine worldwide. We will continue to invest in collaborations so we can bring our full resources and best scientific minds to combat this pandemic,” the company continued. 

BARDA will leverage the Defense Production Act to provide an initial investment of $105 million in funding for Merck, so the company can upgrade and equip its facilities to standards needed for safe manufacturing of the vaccine. 

HHS explained that the company will address all the necessary qualification and validation activities needed for the facilities to be used for large-scale manufacturing.

In addition to the collaboration announcement, President Biden declared that he invoked the Defense Protection Act to expedite materials in vaccine production, including equipment, machinery, and supplies such as single-use bags. 

Biden has also directed the Department of Defense (DoD) to provide daily logistical support to strengthen Johnson & Johnson’s efforts. The company will operate its manufacturing facilities 24/7 to maximize production output. 

These recent efforts will continue to enhance Johnson & Johnson’s ability to boost delivery of its COVID-19 vaccine doses from 100 million doses by the end of June to 100 million doses by the end of May, HHS said. 

At the beginning of February, Johnson & Johnson announced that a single-dose of Ad26.COV2.S was 66 percent effective at preventing moderate to severe coronavirus in a Phase 3 clinical trial. 

The trial enrolled 43,783 participants, of which 468 had symptomatic cases of COVID-19. The co-primary results were measured 14 and 28 days after vaccination. 

Efficacy against the virus increased over time, with no cases in vaccinated participants reported after Day 49, the company said. 

Additionally, Ad26.COV2.S significantly helped infected individuals requiring medical intervention, including hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation. There were no reported cases among participants who received the vaccine.

FDA has authorized the single-dose vaccine to be distributed in the US for use in individuals 18 years of age and older. 

The agency determined that Ad26.COV2.S met criteria to issue an emergency use authorization based on data that showed the vaccine’s known and potential benefits outweighed its known and potential risks.