At the end of May, Chen Pei-jer (陳培哲), a member of an expert committee to evaluate COVID-19 vaccines for use in Taiwan, resigned. Chen’s resignation came after he learned that the Food and Drug Administration (FDA) planned to take a regulatory shortcut in approving two vaccines being developed in the nation. 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 obtain vaccines amid its worst COVID-19 outbreak 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, adding that the move could soon become more common worldwide. That is because as more COVID-19 vaccines roll out, it is getting increasingly difficult to conduct the usual tests of a vaccine’s efficacy.
Photo: Chiang Ying-ying, AP
However, 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, 蔡英文] — we don’t have enough vaccines, and the ruling party is very anxious,” Chen said, referring to Tsai’s remarks in May that the first batch of domestically made vaccines would be ready this month.
Those remarks were viewed by some as putting pressure on regulators before interim data was even analyzed. Tsai has since revised her comments to say that July is a goal and she hoped the first batch would be ready by then.
Chen, a member of Academia Sinica, the nation’s top research institute, said he resigned because he felt politics had interfered with what should be an independent, scientific process. He added that he felt the proposed shortcut did not have enough scientific evidence or global recognition to justify it.
Vaccines that are in use globally have gone through large, final clinical trials 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 COVID-19, but it is not definitive.
Taiwanese experts who support the approach say there is sufficient evidence and urgency as the nation battles an outbreak. As of Sunday, only 10.18 percent of the population had received a first dose of a vaccine, as the nation has struggled to secure doses because of a global supply crunch. As of yesterday, the COVID-19 death toll totaled 689 people from about a dozen prior to the current outbreak.
“Now with COVID-19 you can’t do it that way, where you wait until a randomized clinical trial — people are dying,” said Ho Mei-shang (何美鄉), an epidemiologist at Academia Sinica who has also worked for the US Centers for Disease Control and Prevention. “In the short term we are not going to get our sufficient amount of vaccines.”
At least three countries have allowed early use of vaccines even without the final testing. Russia and China started giving shots last year before finishing their last stage of trials, leading to global criticism. India’s early approval of a vaccine sparked anger and mistrust in its medical community. Elsewhere, most countries and the WHO have only granted approval after the final study.
Authorities such as the US FDA and the European Medicines Agency, which are often looked to globally for their regulatory decisions, have said they would approve vaccines based on antibody data if an already approved vaccine is being redeveloped for a variant. They have not said the same for a new vaccine.
The UK is looking at possibly doing the same as Taiwan. The UK National Institute for Health Research is testing a new vaccine developed by French company Valneva to see if it generates antibodies comparable with the AstraZeneca vaccine in 4,000 volunteers.
If the approach works in Taiwan and the UK, it could be a life-saver for vaccine developers and countries badly in need of doses. As more people get access to vaccines, the ethics and difficulty of doing one of these trials — in which one group gets the vaccine and the other gets a placebo — becomes more complex.
“Who would accept a placebo if they knew they can get a vaccine?” said Jerome Kim, director general of the UN agency International Vaccine Institute.
Giving a volunteer a placebo and subjecting them to the risk of possibly getting infected when proven vaccines are available might be considered unethical by some regulators, he added.
Taiwanese regulators have said they would grant emergency use approval to two vaccines in development by Medigen Vaccine Biologics Corp and United Biomedical Inc if they pass the antibody test. Medigen last month said it had submitted an application for emergency use to the FDA, and planned to conduct the third and final stage clinical trials after approval.
“The reasons are the difficulty to execute the conventional phase 3 study and also the ethical challenge,” the company said in an e-mail response to questions.
United Biomedical last month said it had signed a deal of 1 million doses with Paraguay, one of Taiwan’s diplomatic allies, to be delivered once the Taiwanese FDA gives its vaccine emergency-use authorization. The company is finishing mid-stage testing.
Taiwan has been considering taking this path since at least last fall, when it seemed it would be unable to do the last stage of clinical trials because the virus was under control and people were not getting infected anyway.
“It doesn’t mean it’s an unusual decision or a crazy decision, it’s relevant to circumstances,” said Nikolai Petrovsky, a vaccine expert at Flinders University in Australia.
Opposition parties have seized on the issue, criticizing the government for pushing ahead with a standard not yet accepted globally, and wondering if the government was playing favorites with domestic companies.
K. Arnold Chan (陳建煒), a clinical trials expert at National Taiwan University and a member of the expert panel in Taiwan, said that there are lot of uncertainties with vaccine development.
He cited German company CureVac, which recently announced disappointing results from a large late-stage study for its COVID-19 vaccine that found efficacy was below 50 percent.
“You can imagine the ramifications that someone is thought to be protected, but is not, and it’s not stopping the chain of infection,” Chan said. “The risk is we spent a lot of money [and] we purchased a very expensive placebo.”
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