TAIPEI – In what is being seen as an effort to boost confidence in home-grown vaccines, Taiwan’s President Tsai Ing-wen and Vice President William Lai have signed up to receive them.

Both domestically-developed vaccines remain controversial as they have not undergone phase 3 clinical trials which are critical for determining if they offer protection against a particular virus.

As a result many Taiwanese are reluctant to receive them, worried about the possibility that the vaccines will not be recognised abroad.

“I want to travel overseas as soon as the pandemic is over, but I don’t want to be denied entry by countries that ask to see if one is vaccinated with certain vaccine brands,” said Mr Liu Wei-cheng, 31, a bank manager based in Taipei.

Tealeaf salesperson Ms Lee Meng-yu, 30, said she was unsure about the vaccine’s efficacy because of the lack of phase 3 clinical trials. “I think I’m going to wait and see what the vaccination results are like when others receive their jabs. I’m not in a hurry to travel, so I can afford to wait,” she said.

President Tsai has opted for the vaccine produced by Medigen Vaccine Biologics Corp, a protein-based one like the Novavax vaccine which has still to be approved by the US Food and Drug Administration. Vice President Lai has signed up for United Biopharma’s vaccine.

Both Medigen and United Biopharma, which is also similar to Novavax, have been controversial in Taiwan because regulatory authorities on the island used a new standard in the approval process. Medigen has already received emergency use authorisation (EUA) under the standard, which is still the subject of debate elsewhere in the world.

As part of the process, Taiwanese experts looked at samples of serum neutralizing antibodies taken from participants in Medigen’s phase two clinical trial four weeks after they received their second doses. The results were analysed through a method known as immunobridging which compares the efficacy of an approved vaccine with a trial one by measuring the concentration of neutralizing antibodies in each group of recipients.

Local media said that in the case of Medigen, those who received it in phase 2 trials must present an antibody concentration at least as high as that found in 200 Taiwanese who received both doses of the AstraZeneca vaccine.

On Monday (Aug 2), Taiwan’s Food and Drug Administration (FDA) announced that it had completed inspecting the first four batches of Medigen and that they would be sent out to be administered throughout the island soon.

On the same day, the Central Epidemic Command Centre (CECC) released the results of a debate by a panel of experts,whose identities were kept under wraps, on the Medigen vaccine. The 21 experts had voted in July to grant emergency use authorisation (EUA) to the vaccine but, according to the CECC, also questioned whether it would be effective against new coronavirus variants.

The experts called for the phase 3 clinical trials to be conducted in Taiwan, said the CECC.

The controversy surrounding the vaccine has entered the political sphere with leading figures in the main opposition party, the Kuomintang, casting doubt on the EUA granted to Medigen.

Former KMT Chairman Hau Lung-bin and former Health Minister Yaung Chih-liang said on Monday that they would appeal to the Taipei High Administrative Court to revoke the EUA.

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Mr Hau said the government ought to only grant EUA to a vaccine after the manufacturer phase 3 clinical trial results were presented to the public, adding that there was a need for manufacturers to meet international vaccine production standards.

But Taiwanese may be left with little choice about which vaccine they will receive, as the island is currently still struggling to obtain enough doses for all of its 23.7 million residents.

“Seeing how we don’t have enough vaccines to go around, I may be open to getting a local vaccine. But this means the government would have to allow us booster shots to travel abroad if our own vaccines are not recognised internationally,” said Mr Liu.

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