At the end of May, Chen Pei-jer, a member of an expert committee in Taiwan to evaluate Covid-19 vaccines for use on the island, resigned. Chen’s resignation came after he learned that Taiwan’s Food and Drug Administration planned to take a regulatory shortcut in approving two vaccines being developed in Taiwan. The shortcut would allow the shots to be given to people for emergency use before the vaccines have finished the final stage of testing. The proposed shortcut comes as Taiwan scrambles to get vaccines amid its worst outbreak of the pandemic, and has also recorded its first cases of the highly contagious delta variant originally found in India.
Supporters say the shortcut is needed because Taiwan is in a real crunch, and they argue that the move could soon become more common worldwide. That’s because as more vaccines roll out, it’s getting increasingly difficult to conduct the usual tests of a vaccine’s efficacy. But as Chen’s resignation shows, the proposed move has also raised concerns about the risks, chiefly regarding whether people might be given a vaccine that ultimately is shown not to work. This is a shortcut, and this has to do with President Tsai (Ing-wen) we don’t have enough vaccines, and the ruling party is very anxious, said Chen, referring to the president’s remarks in May saying the first batch of domestically made vaccines would be ready in July. Those remarks were viewed by some as putting pressure on regulators before interim data was even analysed.
Tsai has since revised her comments to say July is a goal, and she hopes the first batch will be ready by then. Chen, a member of Taiwan’s Academia Sinica, a top government-backed research institute, said he resigned because he felt politics had interfered with what should be an independent, scientific process. He also felt the proposed shortcut didn’t have enough scientific evidence or global recognition to justify it. Vaccines that are in use globally have gone through a final stage of clinical trials large, carefully designed studies in which the vaccine is given to people who are monitored against a non-vaccinated group to see if the former are more protected from the disease. Taiwan’s shortcut would give emergency-use approval to two vaccines before those studies, although the two shots have gone through first and mid-stage testing just like other vaccines. Instead, the makers would have to demonstrate that the vaccines generate antibodies against Covid-19 at the same level as the AstraZeneca vaccine, which has already been approved for use in Taiwan. There is growing evidence that the level of antibodies in a person’s blood means a certain level of protection from Covd=id-19, but it is not definitive. Taiwanese experts who support the approach say there’s sufficient evidence and urgency as the island battles an ongoing outbreak.