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Crucial coronavirus vaccine results are unlikely to come in October, JPMorgan biotech analysts concluded after running 10,000 simulations on how these studies could play out.
Vaccines have progressed with unprecedented speed, with a handful of vaccine candidates now in the final stage of clinical testing. These phase-three trials are recruiting tens of thousands of volunteers to determine if a shot is safe and can actually prevent infection or disease compared to a group receiving a placebo.
While there are more than 175 vaccine candidates in research and 32 shots in clinical trials, three programs have separated from the pack with the speediest timelines. These programs — led by Moderna, Pfizer and BioNTech, and AstraZeneca — are aiming to produce pivotal data this fall that could support an emergency approval.
AstraZeneca’s candidate recently hit a stumbling block, as a participant suffered a serious side effect in the trial leading the company to pause its studies. While the UK-based trial has now resumed, other global studies, including in the US, remain on hold with researchers investigating the adverse event.
JPMorgan analysts ran 1,000 simulations across 10 potential scenarios for Pfizer’s and Moderna’s vaccines. They found a “low probability” for data to come in October. It’s more likely we’ll get key data from these trials in November or December, according to their analysis.
The timing for data has become an intense area of debate, particularly as President Donald Trump has explicitly tied a vaccine readout to the November 3 election date. While Pfizer CEO Albert Bourla has repeatedly expressed confidence that the New York pharma will have efficacy data by the end of October, top vaccine experts have been less optimistic.
Moncef Slaoui, the chief advisor to the Trump administration’s vaccine development program Operation Warp Speed, said having data in October is “extremely unlikely.” Dr. Anthony Fauci, the nation’s top infectious disease expert, has also called the October timeline unlikely but not impossible.
Read more: Don’t expect a coronavirus vaccine before the election — here’s the likely timeline according to doctors, government officials, and analysts
Further muddying the waters, Pfizer and Moderna haven’t spelled out exactly how interim analyses will be done and what will be required to stop the trial early.
“We’ll be the first to acknowledge that what actually occurs is a moving target given our incomplete knowledge of Phase 3 trial design details / characteristics, the difficulty of forecasting infection rates, random chance, and unknown unknowns,” JPMorgan analysts noted.
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Source:: Business Insider