J&J taps into BARDA well a third time to speed up its PhIII Covid-19 vaccine trial
BARDA is pouring $454 million more into Johnson & Johnson’s Covid-19 vaccine efforts, as the pharma huffs and puffs to catch up with fast-moving frontrunners Pfizer/BioNTech and Moderna.
Janssen, the J&J subsidiary developing the vaccine candidate, has already received over $1.4 billion from the HHS department. Under the expanded agreement, BARDA will kick in another $454 million to support the company’s 60,000-person Phase III trial, and J&J will commit another $604 million.
The company previously aimed to read out data this year, but J&J head of global R&D Mathai Mammen told Bloomberg last week that the lofty goal is now “a bit of a stretch.” Only a few thousand patients have enrolled in the trial, which is partially due to a brief pause after one participant developed an unexplained illness, he said. The trial resumed late last month, after the company announced that no clear cause was identified. They said there’s “no evidence that the vaccine caused the event.”
Slow enrollment puts the candidate, JNJ-78436735, far behind Pfizer and Moderna, which have both read out results from their first Phase III interim analyses. Pfizer said its BioNTech-partnered candidate proved to be more than 90% effective, and Moderna announced today that its own candidate appears to be 94.5% effective. Both candidates should produce the necessary safety data to apply for emergency authorization this month.
But J&J isn’t out of the game just yet. While Pfizer and Moderna rush two-dose candidates to approval, J&J was the first company to enter Phase III with a single-dose regimen. A single-dose candidate could ease manufacturing and distribution, which has become something of a headache for others in the race.
Last week, J&J partnered with UnitedHealth to accelerate enrollment. It plans on using the health care company’s trove of data to help identify new trial sites and achieve a more diverse participant population. “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,” UnitedHealth CSO Ken Ehlert told Bloomberg. The companies hope their collaboration can slash the Phase III trial time in half.
“We greatly value the ongoing confidence and support of our investigational COVID-19 vaccine candidate development program,” J&J CSO and executive committee vice chairman Paul Stoffels said about the new BARDA agreement. “Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide COVID-19 pandemic.”
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