Johnson & Johnson trial paused following an unexplained illness

Image by Public Co from Pixabay

The Johnson & Johnson trial for its late-stage coronavirus vaccine had been put on hold following an unexplained illness in one of its patients.

The company had to stop the trial after an adverse event happened to one of its patients about 36 hours earlier, CFO Joseph Wolk told CNBC on “Squawk Box.”

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The Johnson’s & Johnson’s trial pause will be followed by an investigation on the incident by the data and safety monitoring board.

“We’re letting safety protocol follow proper procedure here,” Wolk said, stressing that pauses in clinical trials are “not uncommon.”

“What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here,” he noted.

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STAT News reported on Monday that J&J confirmed that a “pausing rule” in the 60,000-patient clinical trial had been met. However, the company did not reveal more details about the patient.

“We must respect this participant’s privacy,” the company said in a statement. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

J&J started its phase three trial testing of its coronavirus vaccine in September. J&J is the fourth drugmaker supported by the Trump administration’s Operation Warp Speed that conduct late-stage testing.

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According to J&J, they are utilizing the same technologies it used to create its experimental Ebola vaccine. The process includes combing genetic material from the coronavirus with a modified adenovirus that usually causes common colds in humans. Preclinical studies indicate that the potential Covid vaccine can lead to a promising response in nonhuman primates and hamsters.

Trial on hamsters

In September, Johnson & Johnson announced that its coronavirus vaccine prevents severe illness in Syrian golden hamsters.

The hamsters were given a single dose of the Johnson & Johnson coronavirus vaccine. The researchers exposed the rodents to the virus four weeks later.

According to J&J, its vaccine was able to elicit neutralizing antibodies, which researchers find critical to build immunity to the virus, in hamsters that took the vaccine. The hamsters that were vaccinated also had less weight than unvaccinated ones and did not manifest severe clinical disease like pneumonia or mortality. J&J’s findings were published Thursday in the medical journal Nature Medicine.

“This pre-clinical study further validates our confidence in our SARS-CoV-2 vaccine candidate,” J&J’s Chief Scientific Officer Paul Stoffels said in a press release. “With our Phase 3 trials planned to start this month, we remain committed to expanding our manufacturing and distribution capabilities to enable global access to our SARS-CoV-2 vaccine candidate should it prove to be safe and effective in humans,” he added.

However, the findings in hamsters do not necessarily suggest that the Johnson & Johnson coronavirus vaccine will offer the same level of protection for humans. The researchers stressed that the results are critical as Covid-19 is found to be developing into severe disease in some humans.

J&J trial data

Based on preclinical studies, J&J’s potential coronavirus vaccine can bring a promising reaction in nonhuman primates and hamsters.

During a conference call, Paul Stoffels, J&J’s chief scientific officer, said that early-stage trial data reveals that the immune response in humans was “comparable to animals, which were protected.” He added that the Covid-19 vaccine seemed well-tolerated, with symptoms like fever fading within 48 hours.

“There are a lot of what we call ‘readiness cohorts,’ where we have predetermined in high risk areas the specific populations we want to target,” he said. “The data teams have been working hard to find out where in the U.S., where in other parts of the world, we can get access to the people and parts of the population at high risk and diverse, which we need to have in the clinical trials,” he added.