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March 16, 20203min930

Coronavirus vaccine trial begins in US

As the race to stop the spread and find actual cure for the novel coronavirus enters frantic stage, a Massachusetts biotech firm is launching human immunization trials today in Seattle.

To show how urgent it is needed, researchers aren’t waiting to see how well it prevents infection in animals before trying it in people, breaking from the usual protocol.

“I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” said Tal Zaks, chief medical officer at Moderna, a Cambridge, Mass.-based biotech that has produced a Covid-19 vaccine candidate at record speed. He told STAT that scientists at the National Institutes of Health are “working on nonclinical research in parallel.” Meanwhile, the clinical trial started recruiting healthy participants in the first week of March.

That isn’t how vaccine testing normally happens. Regulators require that a manufacturer show a product is safe before it goes into people, and while it isn’t enshrined in law, researchers almost always check that a new concoction is effective in lab animals before putting human volunteers at potential risk.

“This is very unusual,” explained Akiko Iwasaki, a Yale University microbiologist who studies the immune response to viruses. “It reflects the urgency to develop vaccines to counter the Covid-19 pandemic.”

To some, the sweep of outbreak is emergency enough to justify simultaneously working on steps that would normally be done sequentially. To others, jumbling the order of the recipe seems morally questionable, because there could potentially be unknown hazards and it’s unclear how effective this particular formulation is.

US boasts of the best medical scientists and labs with best hands in the world, if the test proved successful, it will be a huge leap in what is proving a dirty fight between it and Germany.

While German government is paying more than expected for its company to manufacture vaccines, the US wooed the company with huge sums and was told by the former that its company would manufacture for Germany and the EU first.

Meanwhile, respected Italian journalists have accused Germany of concealing its infections to show its health care system was excellent and the government had established measures to contain the virus. But as government announced its lockdown on Sunday, cases of infections have piked to more than double.

The German government has not refuted the allegation.

Infractions have topped 87,000, surpassing China’s 80,860 cases, across the world with Europe the epicentre.

However three days of rising fresh infections in China have shown that travellers from overseas have been bringing infections mostly from Europe to the country raising concerns of renewed upsurge.

 

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