J&J says its Janssen Adeno vector and PER.C6 technologies provide the ability to rapidly develop and upscale production of its COVID-19 vaccine candidate
Not unexpectedly, much of Johnson & Johnson’s Q1 2020 financial call was taken up with talk of coronavirus.
“COVID-19 is one of the most severe global health challenges we have seen in our lifetimes, but at the same time, we have unprecedented science and technology available today to help us mount a false and effective response,” said CSO Paul Stoffels.
As such, the biopharma giant is hoping to bring a vaccine to fruition against COVID-19. The firm began working on a vaccine candidate in early January once the coronavirus sequence became first available, and at the end of March identified the lead COVID-19 vaccine candidate along with two backups.
Now J&J says it is entering the three candidates into pre-master seed production – with final candidate selection expected in June – as it prepares plans to scale up capacity for such an endeavor.
Currently, J&J has the capacity to produce as many as 300 million doses of a potential vaccine per year from its facility in Leiden, The Netherlands. By expanding global manufacturing capacity in parallel, including establishing a new US vaccine manufacturing capability and working with potential partners to expand manufacturing capacity in Europe and Asia, the firm hopes to begin production at risk imminently with a goal to enable the supply of more than 1 billion doses of the vaccine globally, according Stoffels.
Under these efforts, “production capacity would be ready to go at 600 million to 900 million in the first quarter  going up to one billion in the course of the year, [then] north of one billion by the end of the year, and that’s on an annual basis,” he said on the call. “We will have four manufacturing sites going on one by one bringing the whole capacity up to one billion in the course of the year.”
J&J is well placed to succeed on these aims. The firm has invested heavily to build vaccine capabilities previously used to develop and manufacture Ebola, Zika, RSV and HIV vaccine candidates, and says these programs have helped prove the speed and efficiency of its AdVac viral vector and PER.C6 cell line technologies now they are being leveraged for the COVID-19 program.
“The viral vector platform induces potent and long lasting humoral and cellular immune responses in humans,” said Stoffels. “Further this approach has very low to no risk on the respiratory disease enhancement based on the immune responses observed across our programs. This is in line with the observation that targeted preclinical models used in context of the RSV vaccine development have shown that this platform is not associated with enhanced respiratory disease.”
As such, the platform has a proven safety profile with more than 50,000 people having been inoculated with vaccines produced using the tech.
The PER.C6 cell line, meanwhile, “offers a high yielding vaccine manufacturing platform and is scalable and fully industrialized providing us the ability to make hundreds of millions of vaccines per year,” he added.
“Finally, we have 2 to 8 Celsius stability data on our vaccine making it compatible with standard vaccine distribution channels and therefore will not require new infrastructure to get it to the people who need it.”
While numerous firms are looking to rapidly develop and produce COVID-19 vaccines – for example Moderna, Inovio, Sanofi/GSK, Novavax, CureVac, Pfizer/BioNTech, and even British American Tobacco – Stoffels is confident J&J has what it takes to reach commercialization.
“Based on the WHO criteria for key attributes for prioritizing vaccine platforms, here on the right, the attributes of our platform put us in a leadership position.”