J&J Taps UnitedHealth to Accelerate Covid-19 Vaccine TrialNovember 13, 2020
Johnson & Johnson is turning to data experts atUnitedHealth Group Inc. to accelerate the recruitment of 60,000 participants for the drugmaker’s Covid-19 vaccine trial. Through the partnership, the companies aim to cut the trial time in half.
So far, J&J has enrolled “just a few thousand” patients in its late-stage clinical trial, in part because it lost two weeks when recruitment was paused over a safety concern, Mathai Mammen, head of global research and development at the company’s pharmaceutical division, said in an interview.
Thetrial resumed in late October, and J&J now expects to have an initial readout of results from the trial early next year. While the company previously said it may have data by the end of 2020, that’s now become “a bit of a stretch,” Mammen said. “But I’m hoping soon thereafter we’ll have some data to share.”
UnitedHealth has data on tens of millions of members of its medical and pharmacy plans, as well as patients treated by the 50,000 doctors who work for its Optum unit. Information the company has gathered on virus outbreaks can be used to help determine where to place trial sites moving forward, said Ken Ehlert, the company’s chief scientific officer.
While cases are increasing widely, “they’re not surging in all locations equally right now,” according to Ehlert. “Being in front of that, you really want surges to happen after you vaccinate people so you have the fastest read on whether or not things are working.”
The insurer will also alert members on its website, patients at its clinics, and even its own employees about the trial and steer them to a website where they can “digitally raise their hand and say, I’m interested,” Ehlert said, adding, “the next four or five weeks are going to be really critical.”
The pace of vaccine trials depends on how quickly participants get infected with Covid-19. Researchers gauge how effective a shot is by comparing infection rates between people who were inoculated and those who got a placebo. The faster those infections accumulate, the sooner companies can examine the data and understand how well the vaccine prevents disease.
Along with drawing on UnitedHealth’s data to determine where Covid-19 cases may surge in the weeks ahead, J&J is seeking aid in recruiting Black Americans, people with lower socio-economic status and those with illnesses like diabetes.
Part of the goal for both companies isbuilding trust with communities of color who have historically been mistreated by the medical system.
“We want, need a sufficient number of Black, African-American participants in this trial,” Mammen said. “It’s just so important to me personally, it’s important to both our companies.”
There are more than 200 coronavirus vaccines in development, according to theWorld Health Organization. J&J is one of four companies in late-stage U.S. trials.
Pfizer Inc. and its partnerBioNTech SE reported favorable data this week in an interim analysis that suggested its shot was 90% effective in preventing symptomatic infections. A similar readout fromModerna Inc.’s trial is expected soon.
U.S. officials have bet billions of dollars on experimental vaccines, including J&J’s, with the aim of getting the first successful shots to Americans before the end of the year.
‘Back of the Napkin’
Mammen and Ehlert have known each other for years. They began talking in the spring about how UnitedHealth might be able to speed up J&J’s late-stage vaccine trial. The “back of the napkin” goal was to see if they could cut the trial time in half, they said, while also ensuring they tapped a diverse cohort of participants.
The companies described the work as a collaboration rather than a business relationship. “You’ll get us both in trouble if you ask how much money we’re losing,” Ehlert joked during a joint interview.
Using UnitedHealth’s data, J&J hopes to reach a more diverse pool of participants than it otherwise might.
“It’s actually fairly easy to recruit a study like this if you just go to the colleges and start recruiting tens of thousands of people,” Mammen said. But that approach wouldn’t yield the same number of infections as situating the trial in viral hot spots, nor would it deliver the diversity of participants that J&J is seeking.
The recruitment process “needs to be done in such a way that it is a trust-increasing trial,” Ehlert said. “It is easy in the midst of a pandemic to gloss over just how much the pandemic of mistrust has cost the world and our country and the economy.”
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