GR company producing J and J vaccine ready for FDA approval

GRAND RAPIDS, Mich. (WOOD) — A Grand Rapids company is producing the next great hope for ending the pandemic.

Grand River Aseptic Manufacturing is already making Johnson & Johnson’s one-shot COVID-19 vaccine, which is expected to get the green light from federal regulators any day now.

“I don’t know if a lot of people have realized that there’s a pharma company here that is contributing to this mission right now,” Steven Nole, vice president of operations for GRAM, said.

GRAM, which launched operations in Grand Rapids in 2010, was awarded a contract from the federal government last summer to handle the fill-finish portion of the vaccine production.

“We take the drug substance, which is actually a concentrated bulk of the vaccine, and we basically formulate that into injectable vials,” Nole explained. “There’s a lot of steps in between there. But the bulk product is sterile-filtered and then it’s filled in a sterile environment.”

Many large drugmakers, like Johnson & Johnson, contract out the fill-finish part of the process.

GRAM began the production process, which is overseen by the U.S. Food and Drug Administration, last fall. Security concerns prohibit GRAM from talking about details like the number of vials produced, where it’s stored and other places it’s being produced, but Nole could say GRAM is well prepared for the challenge.

The FDA released documents Wednesday indicating the Johnson & Johnson vaccine is overall safe and highly effective, with an 86% success rate in preventing the most severe outcome of the virus. Overall effectiveness is about 72%.

Independent FDA advisors are expected to meet before the week is out to go over the data and discuss possible emergency use authorization of the vaccine. The FDA generally follows the advice of the independent panel.

Johnson & Johnson has said it is ready to distribute 20 million shots by the end of March. Not only will that help boost the number of shots available, but Johnson & Johnson’s vaccine also doesn’t have to be stored as cold as Pfizer and Moderna’s, both of which also require two shots.

While the production a source of pride for GRAM, it has also requires some expansion. GRAM is looking for fill about 100 jobs as it continues to ramp up production of the vaccine.

“We’re looking for people that have backgrounds in engineering, the sciences; anybody that has previous FDA-regulated experience,” Nole said.

Overall business is up as well, with the company expanding.

“We have purchased two more isolator-based sterile fill lines, which will allow us to basically triple our existing capacity,” Nole said.

It is also building a new state-of-the-art warehouse near the Gerald R. Ford International Airport.

Perhaps the biggest personal benefit for Nole is the chance to tell his future grandkids about the role he and GRAM played in ending the pandemic.

“It’s fantastic opportunity, and we’re very committed to the mission in getting as many vaccines produced as possible,” Nole said.