J&J partners with UnitedHealth to hit the gas on vaccine trial enrollment

Friday, November 13, 2020

Source: Endpoints News

After Pfizer and BioNTech read out the first Phase III interim analysis for their Covid-19 vaccine and Moderna announced it’s not far behind, Johnson & Johnson is looking to catch up.

The pharma is partnering with UnitedHealth Group to speed up enrollment in the hopes of reducing their trial time by half, according to a Bloomberg report. J&J head of global R&D Mathai Mammen told the news agency that they’ve only enrolled a few thousand patients in their 60,000-person trial, adding that the company’s initial goal of having data this year is now “a bit of a stretch.”

Slow enrollment in the trial is partly due to a brief pause, which was caused by the unexplained illness of a participant. The study resumed late last month, and J&J announced that no clear cause has been identified. “Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event,” a statement read.

J&J will have access to UnitedHealth’s trove of data, which could be used to help identify new trial sites or achieve a more diverse participant population, including people of color, those with lower socio-economic status and patients with underlying conditions, UnitedHealth CSO Ken Ehlert told Bloomberg.

“We want, need a sufficient number of Black, African-American participants in this trial,” Mammen told the news agency. “It’s just so important to me personally, it’s important to both our companies.”

J&J had the first single-dose Covid-19 vaccine to enter Phase III testing. This summer, the company announced plans to make over 1 billion doses next year.

Pfizer, which said its candidate with BioNTech is at least 90% effective in preventing symptomatic Covid-19 cases, could apply for a EUA around the third week of November, when it collects the safety data required by the FDA. And Moderna announced Wednesday that it met the threshold required to conduct its own initial Phase III interim analysis, which is likely coming any time now.

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