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Stoffels on how J&J designed its COVID-19 vaccine for maximum impact: a BioCentury audio interview

J&J CSO Paul Stoffels discusses the company’s development of its COVID-19 vaccine

A conversation with Johnson & Johnson CSO Paul Stoffels about the company’s development of a COVID-19 vaccine.

Dec 31, 2020 | 8:04 PM GMT

Johnson & Johnson’s COVID-19 vaccine won’t be the first to reach the market, but it could be one of the most important. The company has made scientific and business decisions about the vaccine’s profile that, if it is demonstrated to be safe and effective, will maximize its utility in combating the pandemic.

The biggest differentiator is that unlike any other COVID-19 vaccine that has been authorized or is in late-stage development, Johnson & Johnson (NYSE:JNJ) designed its vaccine to provide robust, durable protection with a single dose. This will double inventories compared with two-dose vaccines. More importantly, a single dose dramatically reduces the complexity of the vaccine administration process by  eliminating the need for creating and maintaining systems to remind people to return for a second shot.

J&J is on track to produce 1 billion doses in 2021. Half of the company’s 2021 manufacturing capacity is reserved for distribution to the world’s poorest countries through Gavi’s COVAX facility, and all of it will be provided at a not-for-profit price.

As December drew to a close, BioCentury caught up with Paul Stoffels, J&J’s CSO, to discuss progress on the vaccine. He said the company could apply to FDA for emergency use authorization by the end of January, one year after its scientists started designing the vaccine.

Operation Warp Speed Chief Adviser Moncef Slaoui told reporters recently that J&J’s vaccine could be authorized in February. If the vaccine is authorized, the additional supplies would accelerate the pace of protection in the U.S. and Western Europe and jump-start vaccination programs in developing countries.

Stoffels noted that the speed and success of COVID-19 vaccine development was enabled by R&D conducted on previous coronavirus outbreaks. He called for increased research on viruses that have the potential to cause similar outbreaks so the world will be better prepared for future outbreaks.

Looking to the future, Stoffels predicted that the COVID-19 response will lead to the establishment of a new scientific field dedicated to pandemic preparedness.

Like Pfizer Inc. (NYSE:PFE) and Moderna Inc. (NASDAQ:MRNA), J&J has committed to unblind its Phase III trial after it receives an emergency use authorization and to provide its vaccine to trial participants who are eligible for vaccination. Individuals should “not be disadvantaged because they participate in a study,” Stoffels told BioCentury.

The logistics of unblinding have not been established. FDA and J&J are considering a blinded crossover design in which every participant in the trial would receive a second dose.

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