Pharmaceutical News
TFDA announced the criteria for vaccine EUA
2021/06/12

In order to establish the regulatory requirements for the Emergency Use Authorization (EUA) for COVID 19 vaccines, the TFDA has been seeking independent and professional opinions on issues such as technical documents and review standards, etc. from experts since 2020.

Though the purpose of the EUA is to satisfy immediate public health needs, the application is still subject to the same review principles for conventional drug applications.  The review will be based on a risk-benefit analysis.  An EUA would be granted only if there are sufficient evidences to justify the quality, safety and preliminary efficacy of the vaccine. 

The review criteria for the EUA for COVID 19 vaccine are as follow:

Document requirements

The TFDA has established the “Regulatory Requirements for the Technical Documents for Obtaining the EUA for COVID 19 Vaccines in Taiwan” based on the expert meeting results in October 2020 and the guidance issued by the US FDA in 2020.   Applicants have to provide the CMC documents, animal study data, all available human clinical trial data and the risk-benefit analysis report. 

Safety criteria

The clinical trial report should be based on at least 3000 subjects who received the vaccine product and were followed up for at least one month after the last dose of the vaccine product.   It is also required to submit the safety data accumulated from studies of all subjects with a median follow-up duration of at least 2 months after the last dose.   The study results on special groups including subjects aged over 65 should also be submitted.

Efficacy criteria

The TFDA has been contemplating about how to support the development of domestic vaccines as it is difficult to conduct large efficacy tests due to the scale of the pandemic in Taiwan.  Therefore, the TFDA commissioned some hospitals to collect the immunogenicity data from 200 people who received AZ vaccines in March.  The TFDA decided to use immunogenicity as surrogate index for efficacy and compared the immunogenicity of domestic vaccines with the data from AZ vaccines.  The domestic vaccines must prove that they are not inferior to the AZ vaccines in neutralizing antibody potency. 

All potential vaccine developers have been informed of these technical document criteria.  The TFDA would like to restate that, as the highest competent authority in charge of drug review and approval, the TFDA will not compromise on the assessment of domestic vaccine products and will continue to protect the public’s health and medication safety.   The EUA will be granted only when the benefits outweigh the risks and in situations of urgent public health needs.

【2021-06-11 / TFDA】