TAIPEI, Taiwan (AP) – In late May, Chen Peijer, a member of a panel of experts in Taiwan to evaluate COVID-19 vaccines for use on the island, resigned.
Chen’s resignation came after learning that the Taiwanese Food and Drug Administration planned to take a regulatory shortcut in approving two vaccines developed in Taiwan. The acronym would allow people to be given the emergency syringes before the vaccines have completed their final testing phase.
The proposed acronym comes when Taiwan scrambled for vaccines during the worst outbreak of the pandemic and also had its first cases of the highly contagious Delta variant, originally found in India. Proponents say the acronym is necessary because Taiwan is in a real crisis, and they argue that the move could soon spread around the world. This is because the more vaccines are introduced, the more difficult it is to do the usual tests of a vaccine’s effectiveness.
But as Chen’s resignation shows, the proposed move has also raised concerns about the risks, most notably over whether people might be given a vaccine that ultimately doesn’t work.
“This is an acronym, and this has to do with President Tsai (Ing-wen) – we don’t have enough vaccines and the ruling party is very concerned,” said Chen, referring to the president’s remarks in May. July would be a batch domestically manufactured vaccines will be ready. These comments were viewed by some as putting pressure on regulators before the preliminary data was even analyzed.
Since then, Tsai has revised her comments to make July a target, and she hopes the first batch will be ready by then.
Chen, a member of Taiwan’s Academia Sinica, a leading government-sponsored research institute, said he resigned because he believed the politics had disrupted an independent, scientific process. He also felt that the proposed acronym didn’t have enough scientific evidence or global recognition to justify it.
Vaccines used around the world have gone through a final phase of clinical trials – large, carefully planned trials in which the vaccine is given to people who are monitored against an unvaccinated group to see if the former are better protected against the disease are.
Taiwan’s abbreviation would allow two vaccines to be approved for emergency use prior to these trials, although like other vaccines, the two vaccines have gone through the first and mid-stage testing. Instead, manufacturers would have to prove that the vaccines generate antibodies against COVID-19 at the same level as the AstraZeneca vaccine, which is already approved in Taiwan.
There is growing evidence that the level of antibodies in a person’s blood implies some level of protection from COVID-19, but it is not final.
Taiwanese experts who support the approach say there is enough evidence and urgency as the island battles an ongoing outbreak. It has vaccinated only 4% of its population of 24 million people and is having difficulty getting doses due to a global supply crisis. As of Sunday, the death toll from COVID-19 has risen to 686 people, from just a dozen or so before the current outbreak.
“With COVID-19, you can’t do it now waiting for a randomized clinical trial – people are dying,” said Ho Mei-Shang, a vaccine expert in Taiwan who has also worked for the US Centers for Disease Control and prevention. “In the short term, we’re not going to get enough vaccines.”
At least three countries have approved the early use of vaccines without final testing. Russia and China started shooting shots before the completion of their final stage of the process last year, which sparked global criticism. India’s early approval of a vaccine sparked anger and suspicion in its medical community.
In other countries, most countries and the WHO did not grant approval until the study was completed. Authorities such as the US FDA and the European EMEA, which are often used worldwide for their regulatory decisions, have announced that they will approve vaccines on the basis of antibody data if an already approved vaccine is newly developed for a variant. They didn’t say the same thing for a new vaccine.
Britain is considering possibly doing the same as Taiwan. The UK government’s National Institute for Health Research is testing a new vaccine developed by French company Valneva to see if it produces antibodies comparable to the AstraZeneca vaccine in 4,000 volunteers.
If the approach works in the UK and Taiwan, it could be lifesaving for vaccine developers and countries in dire need of doses.
As more people gain access to vaccines, the ethics and difficulty of conducting any of these studies – where one group is given the vaccine and the other a placebo – becomes more complex.
“Who would accept a placebo if they knew they could get a vaccine?” said Jerome Kim, head of the International Vaccination Institute, a UN agency.
It might be considered unethical by some regulators to give a volunteer a placebo and put them at risk of possible infection when proven vaccines are available.
Taiwan regulators have announced that two vaccines under development will be given emergency approval if they pass the antibody test. One is being developed by the Taiwanese company Medigen, the other by an American company Vaxxinity, which is testing the vaccine in Taiwan.
Medigen said earlier this month that it had filed an emergency filing with the Taiwanese FDA and planned to conduct the third and final phase of post-approval clinical trials.
“The reasons are the difficulty of conducting the conventional phase 3 study and also the ethical challenge,” the company said in an email response to questions.
Vaxxinity announced in June that they have signed a 1 million doses contract with Paraguay, one of Taiwan’s remaining diplomatic allies, to be delivered once the Taiwanese FDA approves their emergency vaccine. The company is finishing the mid-stage testing.
Taiwan has been considering this avenue at least since last fall when it looked like it couldn’t do the final phase of clinical trials because the virus was under control and people weren’t getting infected anyway.
“That doesn’t mean it was an unusual or insane decision, but the circumstances,” said Nikolai Petrovsky, a vaccine expert at Flinders University in Australia.
Opposition parties in Taiwan have taken up the issue, criticizing the government for promoting a standard that is not yet accepted worldwide, and are wondering whether the government is favored by domestic companies.
K. Arnold Chan, an expert on clinical studies at National Taiwan University and a member of the Taiwan Expert Panel, said there are many uncertainties in vaccine development. He referred to CureVac, a German company that recently announced disappointing results from a large late stage for its COVID-19 vaccine that was below 50% effectiveness.
“You can imagine the implications of someone being protected but not being … and it doesn’t stop the chain of infection,” Chan said. “The risk is that we spent a lot of money (and) we bought a very expensive placebo.”