Johnson & Johnson Halts Vaccine Test, WHO Warns Against Harsh Lockdowns to Fight COVID

AHA Publisher — Wed, 14 Oct 2020 07:00:05 +0000

News Staff via CBN News – Johnson & Johnson (J&J) has paused a late-stage study for a potential COVID-19 vaccine while the company investigates whether an “unexplained illness” with one of the study’s participants is related to the shot. The company said in a statement that illnesses, accidents, and other so-called adverse events “are an expected part of any clinical study, especially large studies.” Additionally, physicians and a safety monitoring panel are working to determine what could have caused the illness. The pause encompasses all trials, including a large phase-3 trial that launched in September and focused on recruiting 60,000 people in the US and several other countries. J&J Chief Financial Officer Joseph Wolk said on Tuesday the company remains optimistic the delay will conclude after a few days, but the illness is “still under investigation, and we’re going to let that process play out.” Wolk added, “Right now it’s in the hands of the independent drug-safety monitoring board.” CBN News previously reported on another COVID-19 vaccine that was placed on hold last month after a volunteer came down with an unexplained illness. AstraZeneca, the company developing the vaccine with Oxford University in the United Kingdom, instructed researchers to pause the vaccine trial as a precautionary measure. J&J’s CFO explained the potential for obstacles and setbacks to arise during these types of trials. “This is the largest vaccine study that’s out there,” Wolk said. “It’s endeavoring to study 60,000 patients. When you have a study of that size, it’s not uncommon to see unexpected illnesses within the population. That’s for any drug across any therapeutic area. This is something that’s not foreign in the development process.” WHO Warns Against Lockdowns Meanwhile, World Health Organization (WHO) officials are now warning against lockdowns as a way to try to stop the spread of the coronavirus. Dr. Michael Ryan, executive director of the organization’s health emergencies program explained the significance of preventing another widespread lockdown. “What we want to try and avoid, and sometimes it’s unavoidable – we accept that – but what we want to try and avoid are these massive lockdowns that are so punishing to communities, to society and to everything else,” he said. “So, we don’t want to flip from no cases, everything’s open, a few cases, everything shuts down again, because that’s exactly the sort of scenario that we want to try and avoid.” Ryan added that instead of lockdowns, countries should focus on surveillance, tracking, education, and other measures. To read the original article click here. For more articles from CBN News click here.

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Promising COVID-19 Vaccine Trial on Hold – Setback or Standard Procedure?

AHA Publisher — Fri, 11 Sep 2020 07:00:44 +0000

News Staff via CBN News – There’s been a potential setback in efforts to pursue a COVID-19 vaccine as one of the most promising trials has now been placed on hold. Researchers are pausing the stage three vaccine trial being conducted by Oxford University in the UK after a volunteer came down with an unexplained illness. AstraZeneca, the company developing that vaccine with Oxford, is conducting an investigation to determine if the illness is linked to the trial. In a statement, the company insisted that they won’t seek approval or emergency use until “demonstrating safety and efficacy through a phase 3 clinical study. “The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA)” the statement reads. “FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.” Chief executives of nine drug companies, including AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson, and Merck vowed not to rush a vaccine. The pledge is intended to “help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.” Scientists are evaluating the public health impact of rushing a vaccine and the potential safety concerns, against the effect of delaying this highly anticipated treatment. But, they point out that temporary halts are common in vaccine trials. Meanwhile, two other vaccines are in stage-three trials in the US. Just this week, President Trump said there could be a vaccine before Election Day. “So, we’re going to have a vaccine very soon. Maybe even before a very special date,” he stated. To read the original article click here. For more articles from CBN News click here.

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Johnson & Johnson Halts Vaccine Test, WHO Warns Against Harsh Lockdowns to Fight COVID

Promising COVID-19 Vaccine Trial on Hold – Setback or Standard Procedure?