Minutes of EUA meeting to approve MVC vaccine emerge

03-Aug-2021 Intellasia | TaiwanNews | 7:02 AM Print This Post

Several experts who were present at the emergency use authorisation (EUA) meeting for the Medigen Vaccine Biologics Corp (MVC) COVID-19 vaccine expressed doubts about its protection against the Delta variant.

However, most of them agreed that the vaccine’s efficacy at neutralising antibodies meets EUA standards, according to EUA meeting minutes revealed by the Taiwan Food and Drug Administration (FDA), per CNA.

The MVC vaccine was authorised for emergency use by the FDA on July 19, and the EUA allowed for the manufacture of the vaccine. However, as the EUA meeting was held behind closed doors, doubts have been raised about the objectivity of the screening process.

According to the minutes of the EUA meeting, which was held on July 18, there were 21 experts present. After a round of discussion, votes were cast to decide whether the vaccine should be authorised for emergency use.

Three approved the EUA without any conditions, 15 approved it with conditions, one insisted on more supporting documents, and one lodged an objection against the EUA.

The experts examined the data of the vaccine’s phase I and II clinical analysis results. With regard to efficacy, an immunobridging study showed the geometric mean titer (GMT) value of neutralising antibodies generated by the MVC vaccine to be 3.4 times that of the AstraZeneca (AZ) vaccine, which is up to the EUA standards.

Several experts pointed out that according to the MVC vaccine’s GMT value, the domestic vaccine’s efficacy is somewhere between those of Moderna and AZ. However, whether the efficacy translates into actual protection is still unknown.

The clinical data also showed there are doubts about the effectiveness of the MVC vaccine in providing protection against the Delta and Beta variants, although data shows the new vaccine is more effective in providing protection against the D614G and Gamma variants.

Therefore, a few experts have suggested that MVC continue to study the antibodies, assess whether a third jab will help increase protection, develop improved vaccines to deal with mutation of the virus, and include Taiwanese people in its phase III clinical trials.



Category: Taiwan

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