CORONAVIRUS/Participants in Medigen Phase 3 clinical trials receive first shot

11/04/2021 08:51 PM
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Taipei, Nov. 4 (CNA) Taiwan-based Medigen Vaccine Biologics Corp. said Thursday that all 1,030 participants in its Phase 3 clinical trial in Paraguay have received their first vaccine shot of either the Medigen or AstraZeneca COVID-19 vaccines.

The trial began on Oct. 13, and it will compare recipients of the Medigen and AstraZeneca COVID-19 vaccines via immunobridging, which uses the immune response measured in trial participants to infer a vaccine's overall level of protection.

Authorities in Paraguay said that the trial only needed to consist of 1,000 people, as the company had already acquired adequate safety data from its Phase 2 clinical trial, which had over 3,000 participants, Medigen said in a statement Thursday.

As of Wednesday, half of the 1,030 participants in the trial had received their first Medigen jab and the remainder had gotten their first AstraZeneca jab, Medigen said.

The participants will get their second vaccine dose 28 days after the first, and blood samples taken 14 days after the second dose will be used for analysis, Medigen said.

The trial is expected to produce safety and immunogenicity data in the fourth quarter, Medigen said.

(More AstraZeneca doses have been administered than have been officially received because medical workers can sometimes get more than the standard number of shots from a vial.)
(More AstraZeneca doses have been administered than have been officially received because medical workers can sometimes get more than the standard number of shots from a vial.)

Besides the trial in Paraguay, the Medigen COVID-19 vaccine, a protein subunit vaccine, has also been chosen to take part in the Solidarity Trial Vaccines platform, an international clinical trial platform co-launched by the World Health Organization (WHO).

The platform is "designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts," the WHO said.

In Taiwan, over 620,000 people have been fully inoculated with two doses of the Medigen vaccine as of Thursday, including President Tsai Ing-wen (蔡英文) and Vice President Lai Ching-te (賴清德), shortly after it received an emergency use authorization from the Taiwan Food and Drug Administration on July 19, even though the company at that time had yet to conduct Phase 3 trials.

(By Han Ting-ting and Chiang Yi-ching)

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