After AZ, Another Big Pharma Halts COVID-19 Vaccine Trial Due to Patient Illness
By Ruchi Jhonsa, Ph.D.
In a statement, late night on 12th October, Johnson and Johnson said it had paused all the dosing in Phase 3 clinical trial of its experimental coronavirus vaccine due to the occurrence of unexplained illness in a study participant. J&J described the trial’s halt, which was paused by the study sponsor, a standard component of a clinical trial protocol, and has to happen whenever there is a potentially unexplained illness in one of the trials.
According to J&J’s statement, the cause of the participant’s illness is currently being reviewed by an independent data safety monitoring board along with the company’s own physicians, and further details will be shared after all the facts are determined. The company emphasized that the trial was paused rather than put on clinical hold, a formal regulatory action that can last much longer.
Serious adverse events are commonly seen in clinical trials, and the frequency of such events increases when a large number of participants are involved. AstraZeneca put a global halt on its late phase trial of the COVID-19 vaccine last month after it observed a case of transverse myelitis in a study participant. But as many of the trials are placebo-controlled, meaning half of the participants do not receive a vaccine, it remains unclear whether the participant in question belonged to the placebo group or treatment group. Such events are run through an independent safety monitoring board and thoroughly reviewed by them before the study can be restarted.
However, late last month, the USFDA paused Inovio Pharmaceuticals Inc.’s plans to start a late-stage trial of its coronavirus vaccine, reportedly for a different reason. Inovio claimed that the agency sought further information about the delivery of its DNA vaccine and the halt wasn’t due to any side effects.
The COVID-19 Vaccine Race
Johnson and Johnson is one of the leaders in the race to develop a COVID-19 vaccine. It launched a large, 60,000-participant trial last month before revealing the interim data from the Phase 1/2a trial. The data demonstrated that a single dose of J&J’s vaccine, JNJ-78436735 induced a strong neutralizing antibody response in 98% of participants along with strong T cell responses and Th1 response in participants aged 18 years or older at day 29 post-vaccination.
While holds like these are worthy of applause as they ensure the vaccine’s utmost safety before being publicly rolled out, they are also unnerving for the public who are hoping to get a safe vaccine soon. If the adverse event turns out to be indeed an effect of the vaccine, it could lead to a serious setback for the goal of getting a COVID-19 vaccine to the world as quickly as possible, creating panic in public.
Nevertheless, it is far better for the world to get informed about the concerns. A big misstep in the COVID vaccine space could hurt public sentiments and erode confidence in science. In the current scenario, where vaccine development is politically driven, and the companies face tremendous pressure from the government, it is commendable that big pharma’s are stepping up to take responsibility for any shortcomings in the trials and pause the trial for public well being. In this wake, nine pharmaceutical and biotech companies in the COVID-19 vaccine space have pledged not to roll out partially tested vaccines in public under government pressure. This may delay the release of the vaccines; however, there will be a surety that the vaccine is safe for use.
Editor: Rajaneesh K. Gopinath, Ph.D.
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