TAIPEI, Taiwan (AP) – At the end of May, Chen Pei-jer, a member of an expert committee in Taiwan tasked with evaluating COVID-19 vaccines for use on the island, resigned.
Chen’s resignation came after learning that the Taiwan Food and Drug Administration was planning to take a regulatory shortcut by approving two vaccines in development in Taiwan. The shortcut would allow vaccines to be given to people in an emergency before the vaccines have completed the final stage of testing.
The proposed shortcut comes as Taiwan scrambles to get vaccines amid its worst pandemic outbreak, and also recorded its first cases of the highly contagious disease delta variant originally found in India. Supporters say the shortcut is necessary because Taiwan is in a real crisis, and they argue the move may soon become more common around the world. Indeed, as more and more vaccines are deployed, it becomes more and more difficult to carry out the usual tests for the effectiveness of a vaccine.
But as Chen’s resignation shows, the proposed move also raised concerns about the risks, mainly over whether people might be given a vaccine that ultimately turns out not to work.
“It’s a shortcut, and it has to do with Chairman Tsai (Ing-wen) – we don’t have enough vaccines, and the ruling party is very worried,” Chen said, referring to the remarks of the President. president in May saying the first batch of domestically produced vaccines would be ready in July. These remarks were seen by some as putting pressure on regulators even before the provisional data was analyzed.
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 fellow at Taiwan’s Academia Sinica, a leading government-backed research institute, said he resigned because he felt politics interfered with what should be an independent scientific process. He also felt that the proposed shortcut did not have enough scientific evidence or global recognition to justify it.
The vaccines that are used around the world have gone through a final stage of clinical trials – large, carefully designed studies in which the vaccine is given to people who are being watched against an unvaccinated group to see if the former are better. protected against disease.
Taiwan’s shortcut would give emergency use approval to two vaccines ahead of these studies, although both injections have undergone first and mid-stage testing just like the other vaccines. Instead, manufacturers 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 some level of protection against COVID-19, but it is not definitive.
Taiwanese experts who back the approach say there is enough evidence and urgency as the island battles an ongoing outbreak. It only vaccinated 4% of its population of 24 million people and struggled to get doses due to a global supply shortage. On Sunday, the death toll from COVID-19 rose to 686 people, down from just a dozen before the current outbreak.
“Now with COVID-19, you can’t do it that way, where you wait for a randomized clinical trial – people are dying,” said Ho Mei-Shang, a vaccine expert in Taiwan who also worked for them. United States Centers for Disease. Control and Prevention. “In the short term, we are not going to receive our sufficient amount of vaccine. “
At least three countries have allowed early use of vaccines even without final testing. Russia and China started shooting last year before completing their final leg of the trial, which drew global criticism. India’s early approval of a vaccine has sparked anger and mistrust in its medical community.
Elsewhere, most countries and WHO did not grant approval until after the final study. Authorities like the US FDA and the European EMEA, which are often consulted globally for their regulatory decisions, have said they will approve vaccines based on antibody data if an already approved vaccine is in the works. development for a variant. They didn’t say the same for a new vaccine.
The UK is planning to do the same as Taiwan. The British government’s National Institute for Health Research is testing a new vaccine developed by the French company Valneva to see if it generates antibodies comparable to the AstraZeneca vaccine in 4,000 volunteers.
If the approach works in the UK and Taiwan, it could save the lives of vaccine developers and countries in dire need of doses.
As more and more people gain access to vaccines, the ethics and difficulty of doing any of these trials – in which one group receives the vaccine and the other a placebo – becomes more complex.
“Who would accept a placebo if he knew he could get the vaccine?” Said Jerome Kim, head of the International Vaccine Institute, a United Nations agency.
Giving a volunteer a placebo and subjecting them to the risk of infection when proven vaccines are available may be considered unethical by some regulators, he added.
Taiwanese regulators have said they will grant emergency use authorization to two vaccines in development, if they pass the antibody test. One is developed by the Taiwanese company Medigen, the other by the American company Vaxxinity, which is testing the vaccine in Taiwan.
Medigen said this month that it has submitted an emergency use request to Taiwan’s FDA and plans to conduct the third and final stage clinical trials after approval.
“The reasons are the difficulty in performing the conventional Phase 3 study and also the ethical challenge,” the company said in an email response to the questions.
Vaxxinity announced in June that it had signed a million-dose deal with Paraguay, one of Taiwan’s last diplomatic allies, to be delivered once the Taiwanese FDA approves emergency use of the vaccine. The company is completing the mid-term testing.
Taiwan has been considering going this route since at least last fall, when it looked like they would be unable to complete the final stage of clinical trials because the virus was under control and people were not. infected.
“That doesn’t mean it’s an unusual decision or a crazy decision, it’s relevant to the circumstances,” said Nikolai Petrovsky, vaccine expert at Flinders University in Australia.
Opposition parties in Taiwan have taken hold of the issue, criticizing the government for pushing forward a standard not yet accepted globally, and questioning whether the government is playing favorites with domestic companies.
K. Arnold Chan, expert in clinical trials at National Taiwan University and member of the expert panel in Taiwan, said there are many uncertainties regarding the development of a vaccine. He pointed to CureVac, a German company, which recently announced disappointing results from a large, late-stage study for its COVID-19 vaccine that was less than 50% effective.
“You can imagine the ramifications of thinking someone is protected but isn’t… and that doesn’t stop the chain of infection,” Chan said. “The risk is that we were spending a lot of money, (and) we bought a very expensive placebo.”