GLOBAL NORMS:
The head of the CECC said that the nation’s EUA was based on US guidelines and a WHO study, and the methods were used in other countries

  • By Lee I-chia / Staff reporter

The Central Epidemic Command Center (CECC) yesterday denied a rumor that specialists were asked to manipulate data about COVID-19 vaccines.

The Food and Drug Administration (FDA) on Nov. 3 said a specialists’ panel meeting reviewed the efficacy of the Taiwan-developed Medigen COVID-19 vaccine, and the specialists unanimously agreed that the vaccine was effective, allowing an emergency use authorization (EUA) order to be extended.

Since the announcement, opposition parties have questioned the panel meeting.

Photo courtesy of the Central Epidemic Command Center

The Chinese Nationalist Party (KMT) legislative caucus yesterday said the government was “wrongfully protecting” the Medigen vaccine and questioned the procedures for reviewing and purchasing the vaccine.

A local media firm yesterday published a report citing a doctor who said that as the specialists did not all agree on the vaccine’s effectiveness, the Ministry of Health and Welfare gave them the Centers for Disease Control’s (CDC) data to let the vaccine pass a “makeup exam.”

CDC Deputy Director-General Chuang Jen-hsiang (莊人祥), who is the CECC’s spokesman, said that three sets of data — Medigen Vaccine Biologics Corp’s report, an analysis from a healthcare facility and a CDC statistical analysis — were presented to the panel and were approved before being included as reference material.

The CDC’s report used the same assessment method as other countries, and it should not be confused with the data about adverse post-vaccination reactions that the doctor mentioned in the media report, Chuang said.

He added that the data were analyzed by CDC officials without external assistance.

Deputy Minister of Health and Welfare Victor Wang (王必勝), who heads the CECC, said that prepurchase contracts were signed with two domestic vaccine makers — Medigen being one — just as they were signed with AstraZeneca and Moderna to obtain their vaccines before they finished second or third-phase clinical trials.

That was to ensure that people could be vaccinated as soon as possible after the companies received production authorization, Wang said.

The government referenced the US FDA guidelines for EUA requirements and a WHO immunobridging study in setting Taiwan’s review standards, he said.

The methods were not invented or only used in Taiwan, he said, adding that a vaccine that recently received WHO approval was also reviewed based on immunobridging studies.

Regarding claims that the CECC was keeping vaccine procurement contracts “confidential” for 30 years, Wang said the center has repeatedly said that contracts must be honored by the government for 30 years, but that confidentiality periods were based on nondisclosure agreements set by the manufacturers.

The Ministry of Health and Welfare reported the lengths of each contract at the legislature on Oct. 6, he added.

The WHO is believed to be drafting an act to push for governments and vaccine companies to disclose their procurement agreements, and Taiwan would follow the standards set if passed, he said.

Currently, all countries have signed nondisclosure agreements with vaccine makers, he said.

The CDC’s efficacy report was based on data gathered on more than 60 million vaccine doses administered in Taiwan, he said.

The results showed that the Medigen vaccine offered more than 90 percent protection against moderate-to-severe illness and death, similar to the Moderna and Pfizer-BioNTech vaccines, he said.

Medigen Vaccine Biologics already disclosed the price of its COVID-19 vaccine, which is lower than that of the Moderna and Pfizer-BioNTech vaccines, and evidence has proven the Medigen vaccine’s efficacy, so people should stop spreading rumors for political purposes, he said.

The center would not publish the names of the members of the FDA’s specialists panel to prevent them from being bullied or harassed, he said.

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