Johnson & Johnson Ramping Up COVID-19 U.S. Vaccine Production Globally

The U.S. has begun vaccinations with Johnson & Johnson’s (J&J) single-dose vaccine following the FDA’s authorization over the weekend but confronting a small initial rollout the drugmaker is accelerating dose production and working with multiple manufacturers in the U.S. and at sites in Europe, India and South Africa to meet its supply commitments.

J&J, which is under contract to deliver 100 million doses of its COVID-19 vaccine to the U.S. government in a $1 billion agreement (DID, Aug. 6, 2020), will start off with smaller shipments but intends to drastically increase its vaccine deliveries by the end of the month, according to Mark McClellan, a J&J board member and former FDA commissioner.

“There is going to be a ramp-up period. So, 4 million doses expected [this] week, going higher during the month of March with 20 million doses delivered by the end of March,” he said.

Following that ramp-up, the company expects to deliver the full 100 million doses it’s agreed to supply to the U.S. government by the end of June. To achieve this, the company has designated eight production sites to support manufacturing and intends to hash out more agreements with manufacturers that will further aid in its vaccine production goals.

Three of its vaccine manufacturing partners are in the U.S.: Catalent, Emergent BioSolutions and Grand River Aseptic Manufacturing (GRAM). Emergent BioSolutions is producing large quantities of drug substance used to make the vaccine, while Catalent is providing dedicated, nonstop vaccine production and GRAM is performing advanced aseptic fill-and-finishing services.

Paul Stoffels, J&J’s chief scientific officer, said that the FDA is reportedly evaluating the quality data of a large Catalent facility. Agency approval, which Stoffels expects to be given in the next few days, will enable large-scale manufacturing and shipment of vaccine doses to begin at the site.

J&J is also working with companies abroad, including Reig Jofre in Spain, Biological E. in India and ASPEN Pharmacare in South Africa, as well as Catalent’s Italian site and its own Janssen manufacturing plant in the Netherlands.

“Due to the global interconnectivity of our production and supply-chain processes, one batch of the J&J COVID-19 vaccine will likely visit multiple countries through the course of various manufacturing stages in its journey from drug substance to a finished vial for injection,” the company said.

Alex Gorsky, J&J’s CEO, said the company is working to expand its manufacturing capacity to enable the production of up to 1 billion doses this year for global use.

According to J&J, producing a batch of vaccine from drug substance to fill and finish takes 60 to 70 days, with an additional 18 to 22 days required to do final quality testing and release the product. Once finished, the vaccine can be stored at -4 Fahrenheit (F) for two years, three months of which it can be kept at 36 to 46 F.

The European Medicines Agency will reportedly recommend a conditional marketing authorizing of the J&J vaccine on March 11, and the European Commission is expected to quickly issue the authorization after that. Should it receive conditional marketing authorization, it would become Europe’s fourth COVID-19 vaccine to obtain emergency clearance. — James Miessler