Johnson & Johnson (NYSE: JNJ) reported its earnings on Oct 13th; but the news that captured headlines was that the New Jersey based health care company was forced to pause its vaccines’ Phase 3 trial due to a participants’ unexplained illness. At the time of this articles’ release, it is unknown what the illness is, and whether or not it was from a placebo or the vaccine itself. The company is waiting for an independent advisory board to examine the data and advise on whether or not the trial can be restarted.
Phase 3
What sets Johnson & Johnson apart from other Pharma companies in this space, is that they are the only one with a vaccine in Phase 3 trials that requires one dose instead of two. Phase 3 is an important pre-approval step in the vacccine testing process. During this phase scientists give the vaccine roughly a hundred people in a treatment group and observe how many get infected compared with volunteers who took a placebo.
In June, the FDA advised vaccine makers that they require evidence that any vaccines can protect at least 50% of those that receive it. The trials are made large enough to reveal any rare side effects that may occur using the vaccines. Other US-based companies of note that have a vaccine in Phase 3 trials are Pfizer (NYSE: PFE), Novavax (NASDAQ: NVAX) and Moderna (NASDAQ: MRNA). Here’s a chart on the world’s progress in developing a vaccine thus far, courtesy of the New York Times:
Clinical Trials under a Microscope
Johnson & Johnson is the second company – the first being AstraZeneca (LON: AZN), to pause their vaccine trial in the wake of adverse affects due to a subject’s illness. AstraZeneca halted global trials of their vaccine to investigate one subject who developed an inflammation called transverse myelitis. They have resumed their vaccines trials in the UK but have yet to continue in the U.S. as the FDA is still examining the data. Eli Lily and Co (NYSE: LLY) announced on October 13th that the government-sponsored clinical trial of its COVID-19 vaccine has been paused over a safety concern.
As companies compete to receive approval for their respective vaccines – the mounting demand of governments and the public to find a fast remedy has made clinical trials the subject of unusually close scrutiny. We will continue to watch which emerges with viable options and are able to fulfil lucrative agreements with governments around the world.
