A panel of experts questioned a local vaccine’s efficacy against the variants of SARS-CoV-2, despite last month agreeing to grant it emergency use authorization, according to the minutes of their meeting.
At the meeting on July 18 of a panel of 21 experts, 18 of the 20 who voted agreed to grant emergency use authorization for the vaccine made by Taiwan-based Medigen Vaccine Biologics Corp without the need for phase 3 clinical trial efficacy data, because the vaccine’s production of antibodies in phase 2 trials met preset standards.
They also felt Medigen’s vaccine was proven to be safe during the phase 2 trials.
Given the emergency facing Taiwan amid the COVID-19 pandemic, they believed the benefits of issuing emergency use authorization to Medigen outweighed the risks, according to the minutes, which were made public on Monday.
However, some experts questioned how effective the vaccine would be in the real world, especially against the Delta and Beta variants of SARS-CoV-2.
Lab tests showed that the vaccine’s antibodies showed better results for some of the early variants of COVID-19, such as the Gamma and D614G variants, but poorer results against the Delta and Beta strains, they said.
They also said that in-vitro lab results might not have a linear relationship to the vaccine’s effectiveness in real life and cautioned against drawing any conclusions from them.
As Taiwanese vaccine makers have yet to conduct phase 3 trials, which are the standard for determining whether a vaccine offers protection against a particular virus, the experts called on Medigen to continue to study its vaccine’s efficacy against new variants and see whether a third dose might be needed.
The experts also urged Medigen to consider conducting phase 3 clinical trails in Taiwan, in addition to its trials on 1,000 people in Paraguay.
The minutes were released after opposition parties requested that the emergency use authorization review process be made public, saying that Taiwanese had been kept in the dark.
The approval was controversial because it was based on two standards set by the Food and Drug Administration (FDA) not found elsewhere in the world: The vaccine must have a seroconversion rate of above 50 percent and geometric mean titers (representing the concentration of virus neutralizing antibodies) at least equal to two-thirds of the level found in recipients of the AstraZeneca vaccine.
The Medigen vaccine had a seroconversion rate of 95.5 percent and generated geometric mean titers that were 3.4 times higher than those found in a control group of 200 people in Taiwan who had received two doses of the AstraZeneca vaccine.
When the FDA on July 18 announced the panel’s vote of 18 in favor of the emergency use authorization, one against and one member wanting more documentation, it did not make any more details public, saying that the meeting was held behind closed doors to allow the experts to express their views freely.
Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the Central Epidemic Command Center, later agreed to make public the minutes after redacting the names of the experts.
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