CORONAVIRUS/Medigen COVID-19 vaccine receives EUA in Paraguay
Taipei, Feb. 14 (CNA) A COVID-19 vaccine made in Taiwan by Medigen Vaccine Biologics Corp. has received emergency use authorization (EUA) in Paraguay after the unblinding of a Phase 3 clinical trial conducted in the South American country, the company said in a statement Monday.
The Phase 3 trial in Paraguay sought to test the Medigen vaccine's effectiveness by comparing the amount of neutralizing antibodies it generated in trial participants against those generated by another vaccine, in this case the AstraZeneca vaccine.
The company said the trial, which finished with 934 people getting two doses of one of the two vaccines, found that the Medigen vaccine generated 3.7 times as many neutralizing antibodies as its AstraZeneca counterpart, meeting the standard for "superiority."
That result was similar to the results obtained in Taiwan last year, when the Medigen vaccine became the first (and to date the only) domestically produced vaccine to receive EUA in Taiwan, the company said.
In terms of safety, no serious reactions to the Medigen vaccine were reported among any of the trial participants, and fewer than 1 percent reported getting a fever, according to Medigen.
Paraguay is only the second country in the world to give the Medigen vaccine an EUA, though it is currently undergoing reviews in several other countries and is being tested under the World Health Organization's Phase 3 Solidarity Trial Vaccines program.
When it received an EUA in Taiwan in June 2021, it was the first COVID-19 vaccine in the world to be approved through the process of immunobridging, in which a vaccine's effectiveness is inferred through a comparison of neutralizing antibodies generated rather than actual clinical results in the field.
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