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Japan Requires Domestic Clinical Trials Before Giving COVID Jabs the Green Light

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Japan Requires Domestic Clinical Trials Before Giving COVID Jabs the Green Light

Darren Solman by Darren Solman
March 15, 2021
in Covid-19, Health
Reading Time: 2 mins read
9 0
A A

by Arsenio Toledo (excerpt)

The rollout of Wuhan coronavirus (COVID-19) vaccines in Japan has been delayed due to the country’s insistence on running domestic clinical trials before it approves any vaccine.

The one outstanding condition Japan requires from Moderna, BioNTech-Pfizer, AstraZeneca and several other pharmaceutical companies is that they conduct small clinical trials on Japanese citizens that demonstrate the vaccines are able to generate a similar level of antibodies.

These trials must show that the safety and efficacy of the vaccines do not differ.

If these pharmaceutical companies pass Japan’s requirements, vaccinations can start, at the latest, by the end of February.

This is three months after some of the earliest vaccine rollouts in the West – notably in the United States and the United Kingdom – and less than five months before the Tokyo Olympics start.

“To ask for an additional clinical trial with just 200 people doesn’t make sense,” said Ken Ishii, a professor of vaccine science at the University of Tokyo, and a vocal critic of the Japanese government’s additional requirements for pharmaceutical companies. “It doesn’t give you enough power to tell whether Japanese people are built differently.”

While Ishii said that he understands that Japanese regulators would rather be extra cautious. But he still doesn’t understand why they want to go through with this.

He pointed out that Pfizer’s clinical trials in the U.S. could provide more data regarding how genetics affect safety and efficacy. Of the 40,000 people who participated in the trials, around 800 were of Asian descent.

Japanese officials have argued that this is standard practice. Any vaccine developed abroad must show in a small clinical trial that it can generate a similar level of antibodies when tested on Japanese citizens. Regulators have waived the requirement for placebo-controlled trials…

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I’m Darren, an investigative journalist and founder of 'The Shocking Truth. I’m a real truth-seeker and believe that the truth should be known by all. I also believe that governments, businesses, organisations and individuals should be held accountable for any wrongdoing and this website serves as an excellent place to report on such matters when the mainstream media usually turns a blind eye.

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