In a further blow to the US and UK governments and their pharmaceutical partners, another corporate vaccine firm has been forced to stop clinical trials after a subject fell seriously ill after taking their new experimental vaccine for coronavirus.
Johnson & Johnson Inc pharmaceuticals has temporarily halted its trials after one of its participants became sick.
“We have temporarily paused further dosing in all our Covid-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” said a company spokesperson.
The firm had been planning to ‘enroll’ some 60,000-more subjects for its experimental vaccine trial, but those plans have been put on hold while an independent safety committee can assess the situation.
Not the First Time
This is not the first such incident where a test subject has become sick after taking an experimental COVID vaccination. Back in September, trials for a COVID vaccine made by AstraZeneca and Oxford University were stopped after a UK volunteer contracted an ‘unexplained illness.’
In addition to these casualties, another five US participants – three in Moderna trial and two in Pfizer’s late-stage trials, have reported some serious side effects – including a high fever, shakes, chills, heavy migraines, shortness of breath, exhaustion, and an inability to focus properly, CNBC reported.
“The first dose is no big deal. And then the second dose will definitely put you down for the day for sure. … You will need to take a day off after the second dose.”
All of the major vaccine manufacturers are being subsidized to the tune of tens of billions of dollars by US and UK governments, as well the controversial Bill and Melinda Gates Foundation. “We must make this the decade of vaccines,” said Bill Gates.
The Telegraph reports…
J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies.” Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.
The Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world, the company and the US National Institutes for Health (NIH), which is providing funding, said.
The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
With the move, J&J became the tenth maker globally to conduct a Phase 3 trial against Covid-19, and the fourth in the US.
The US has given J&J about $1.45 billion in funding under Operation Warp Speed.
The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells…
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