The Food and Drug Administration (FDA) yesterday announced emergency use authorization (EUA) standards for locally developed COVID-19 vaccines, just hours before Medigen Vaccine Biologics Corp (高端) announced its phase 2 trial results.
The standards include safety data from at least 3,000 subjects and efficacy test results at least on par with the AstraZeneca vaccine, the FDA said.
The standards were determined after a year of discussions with experts in the clinical, statistical, pharmaceutical, manufacturing, public health and other related fields, it added.
Photo: Huang Mei-chu, Taipei Times
The EUA review is to focus on two main points: safety and efficacy, Medical Products Division deputy head Wu Ming-mei (吳明美) told reporters.
Efficacy would be difficult to assess, as clinical trials were held while Taiwan did not have any community transmission, Wu said.
This means the subjects did not have contact with the virus, making it less clear whether the vaccine had the intended effect compared with the control group, she added.
The review would therefore refer to a criteria the WHO began discussing earlier this year called immunogenicity, which measures the type of immune responses triggered by a vaccine and their magnitude over time, she said.
This would involve measuring the level, or titer, of neutralizing antibodies in the body after vaccination to determine efficacy, she added.
To determine the appropriate level, the FDA is to commission Ministry of Health and Welfare hospitals to conduct studies comparing the effect of domestic vaccines with that of foreign vaccines, Wu said.
Researchers are to put together a control group of 200 Taiwanese who have received both doses of the AstraZeneca vaccine since rollout began in March, she said.
If the neutralizing antibody titer among subjects who received the domestic vaccine are at least as high as that of the control group, then the vaccine would be considered effective, she added.
As for the safety part of the evaluation, the FDA would require researchers to follow up with 3,000 or more clinical trial participants for at least one month after receiving their last dose, Wu said.
The report must then compile safety data from the subjects followed for a median of at least two months, she said, adding that it must include a population study for people older than 65.
Medigen was yesterday set to unblind participants of the second stage of clinical trials for its COVID-19 vaccine, leading some to speculate over potential insights into its efficacy.
The unblinding would only reveal if there were differences between the subjects who received a vaccine and those who received a placebo, Wu said.
The results must still be sent to the FDA before it can begin EUA procedures, she added.
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