by Arsenio Toledo (excerpt)
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…