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Taiwan COVID vaccine maker says it had wanted to do stage 3 trials

ROC Central News Agency

06/03/2021 11:13 PM

Taipei, June 3 (CNA) United Biomedical, a Taiwan biopharmaceutical firm developing COVID-19 vaccines, on Thursday said it had initially planned on following international norm and entering phase 3 clinical trials before seeking government approval for its COVID-19 vaccine.

In response to public concerns that United Biomedical's vaccines could be launched without going through phase-three clinical trials, the company's Chief Operating Officer (COO) Peng Wen-jiun (彭文君) said at a forum that the company had initially planned on following through the international norm, but Taiwan's Center for Drug Evaluation (CDE) and Food and Drug Administration (FDA) suggested that the company increase the number of participants to a larger-than-normal scale in the second phase of clinical trials instead.

Peng made the remarks at a virtual forum organized by the opposition party Kuomintang-affiliated National Policy Foundation.

Typically, trials testing potential medical products are commonly classified into three phases, ranging from a few dozen participants in phase-one trials to several hundred in phase-two, with the participant numbers in the third phase going up to several thousands or tens of thousands.

After meetings with medical experts from the CDE and FDA, however, a consensus was reached to push ahead with an expedited process after completion of the first-phase clinical trial, Peng said.

Peng explained it wasn't United Biomedical's original intention, but it was something that the CDE and FDA wished the company could do in order for the vaccines to get approved for an emergency use authorization (EUA).

Taiwan's government officials have recently argued that the number of participants in the first and second phases of the United Biomedical and another Taiwanese vaccine maker's clinical trials were more than the number of participants in those two phases of trials conducted by the internationally approved vaccines Pfizer/BioNTech, Moderna and AstraZeneca.

According to a chart released earlier this week by Health Minister Chen Shih-chung (陳時中), who also heads the Central Epidemic Command Center (CECC), the numbers of participants involved in the first and second stages of clinical trials carried out by United Biomedical were 3,875 and 3,844, respectively.

Medigen Vaccine Biologics Corp., the other domestic company with a COVID-19 vaccine in stage-two clinical trials, has so far involved 3,852 and 3,815 people in their first-stage and second-stage clinical trials, the chart showed.

The government had already placed orders for 5 million doses of vaccines from each of the two Taiwanese vaccine makers, with President Tsai Ing-wen saying they would be available in July.

However, there's been widespread public concerns that while the two Taiwanese vaccine makers may have used a larger number of participants than usual in the first two phases of clinical trials, they have not begun the phase three clinical trials, in which vaccines would be further tested for efficacy and safety.

There are worries the Taiwanese vaccines will receive government approval and be given to the public without being required to undergo phase three trials.

The vaccines produced by Moderna and Pfizer-BioNTech were each approved for an EUA by the Food and Drug Administration of the United States in December last year while stage-three clinical trials were still ongoing.

However, they were approved for a EUA after the efficacy of their vaccines, side effects, and other data from all three stages of clinical trials were reviewed, even though they had not completed the third phase of their trials at the time.

The Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines had included over 35,000, 30,000, and 40,000 participants, respectively, in their studies at the time they obtained emergency use authorization in the United States, according to information on the U.S. Food and Drug Administration website.

Peng said on Thursday his company is expected to complete the unblinding procedure of its second-stage clinical trials this month, meaning they will inform the people who participated in the clinical trials whether they had received the vaccine or a placebo.

In clinical trials, blinding means neither the group given the vaccine nor the group given the placebo are told what they've been given, in order to study the effects of the vaccine on the group that got the vaccine in an objective way.

Peng said after the unblinding procedure is completed, the company plans to apply with Taiwan's Food and Drug Administration for an EUA at the end of June. It hopes to start delivery of the vaccine in Taiwan in July, Peng said.

There is however still a chance that the unblinding trials fail, and if that is the case then there will be no EUA, Peng said.

Taiwan government's contract with United Biomedical is an order placement, he said, meaning that without the EUA there will basically be no procurement and as such the company will have to bear the loss.

Developing any type of vaccine can cost anywhere over US$1 billion, which involves the purchase of raw materials and research and development, the COO said.

He said the company is also currently focusing on developing a vaccine against new COVID-19 variants.

Peng also pointed out that in terms of the number of people infected with COVID-19, there is still a huge disparity between Taiwan and many other countries in the rest of the world, therefore Taiwan does not have the ideal conditions for a stage-three clinical trial, but rather a "quasi-stage three trial" instead.

Both United Biomedical and Medigen have said they plan to conduct stage-three trials, possibly in countries such as India, to obtain international certification.

(By Liu Kuan-ting and Ko Lin)

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