Johnson & Johnson single-dose vaccine is safe and effective, FDA says
Johnson & Johnson is looking for manufacturing partnerships to increase supply of its COVID-19 vaccine that was cleared Saturday by U.S. regulators, Chief Executive Officer Alex Gorsky said.
J&J will deliver 3.9 million doses of its one-shot vaccine within the next 24 to 48 hours, Gorsky said Monday in a telephone interview. The company wants to speed up its timeline of supplying enough vaccines to immunize 20 million Americans by the end of the month and a total of 100 million by the end of June, he said.
“We are doing everything we can partnering with the U.S. government and other external manufacturers to see what we can do to accelerate and increase that number as well,” Gorsky said.
New Brunswick, New Jersey-based J&J rose as much as 1.9 per cent as of 10:14 a.m. in New York.
J&J’s manufacturing footprint for its COVID-19 vaccine spans the U.S., Europe, Asia and Africa, and the company aims to have eight facilities operating by midyear. Production, including quality testing and release, takes roughly three months, during which the vaccine often crosses multiple borders for various steps.
Gorsky acknowledged that the company had hit supply snags in its efforts to boost production in the U.S. In its initial contract with the Trump administration, J&J agreed to supply 12 million doses by the end of February, including two million it planned to deliver in January.
“In my more than 30 years in the industry, what I can tell you is this kind of a ramp-up is never -- or rarely -- what I would call a linear shot,” Gorsky said. “There are almost always going to be unanticipated challenges along the way.”
In the U.S., J&J has contracted Catalent Inc. and Grand River Aseptic Manufacturing Inc. to fill its vials with the drug substance.
“One of our facilities was literally a parking lot 12 months ago,” Gorsky said. “Today it’s one of the most advanced bio-pharmaceutical vaccine manufacturing facilities in the world. We’re learning along the way.”
No Stone Unturned
The company is focusing on two parts of its production process for improvement. One is its capacity for making a live cold virus, called an adenovirus, that’s used in the shot to trigger an immune response that fights off infection.
Gorksy also wants to augment the company’s fill-finish facilities, a final step where the vaccine is placed in vials. Fill-finish capacity is limited, he said, and as result, the company is looking to increase it in the future.
“We’re leaving no stone unturned in terms of partnerships,” he said. “One of the most important lessons of the pandemic is the power of collaboration.”
J&J remains in active discussions with the U.S. government about exercising options for additional doses, Gorsky said. Globally, he sees it serving an important role, too.
The company will be offering the shot on a not-for-profit basis amid the pandemic, at a price that will not exceed US$10. In comparison, the Pfizer Inc.-BioNTech SE vaccine costs the U.S. US$39 for the full regimen, while Moderna’s goes for US$33 for both doses. The price difference will be important abroad, Gorsky said.