Grand River Aseptic Manufacturing (GRAM), based in Grand Rapids, Michigan, inked a deal with Janssen Pharmaceutical, a Johnson & Johnson company, to support the manufacturing of Janssen’s COVID-19 vaccine candidate. GRAM is an injectable contract development and manufacturing organization (CDMO).
Just about a week ago, on September 23, J&J announced it had launched its large-scale, international Phase III trial for its COVID-19 vaccine candidate, JNJ-78436735. The vaccine was developed by Janssen using its AdVac technology platform, which is also used to develop its Ebola vaccine that was approved in Europe and to develop its Zika, RSV, and HIV vaccine candidates.
The J&J COVID-19 vaccine candidate appears to have the advantage of being stable at more typical vaccine storage temperatures, for two years at -20 degrees C and at least three months at 2-8 degrees C. Some of the other candidate vaccines require storage at -80 degrees C, with others -60 degrees C. Another advantage is it appears to require only a single dose. Several other candidate vaccines require two doses about 28 days apart.
The agreement with GRAM includes technical transfer and fill-and-finish manufacture of the vaccine candidate. GRAM has a new, state-of-the-art facility.
“Should their vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the COVID-19 pandemic alongside Johnson & Johnson is an extraordinary privilege,” said Tom Ross, president and chief executive officer of GRAM. “Our team is enthusiastic, dedicated and focused on supporting Johnson & Johnson in the fight against COVID-19.”
GRAM is expanding domestic fill-and-finish capacity for COVID-19 vaccines and drugs for companies that have deals with the federal government’s Operation Warp Speed. The expansion is partially funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in collaboration with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
J&J’s Phase III ENSEMBLE trial will study the safety and efficacy of a single dose of the vaccine compared to placebo in up to 60,000 adults ages 18 years and older, with “significant representation from those that are over age 60.” It expects to enroll volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the U.S. It also expects to include people with and without comorbidities linked to increased risk for progression to severe disease. In the U.S., it will include significant representation of Black, Hispanic/Latinx, American Indian and Alaska Native volunteers.
In announcing the clinical trial, Alex Gorsky, chairman and chief executive officer of J&J, said, “As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”