CORONAVIRUS/Medigen COVID-19 vaccine receives EUA in Paraguay

02/14/2022 11:28 PM
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Image taken from the Website of Paraguay’s Ministry of Public Health and Social Welfare
Image taken from the Website of Paraguay’s Ministry of Public Health and Social Welfare

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.

1. More doses of the Moderna vaccine have been administered in Taiwan than the government has officially received because recipients of the Moderna booster shot are given half the standard dose of the first and second jab. 2. Information about the booster dose and additional dose can be found at https://t.ly/4ZuW
1. More doses of the Moderna vaccine have been administered in Taiwan than the government has officially received because recipients of the Moderna booster shot are given half the standard dose of the first and second jab. 2. Information about the booster dose and additional dose can be found at https://t.ly/4ZuW

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.

(By Han Ting-ting and Luke Sabatier)

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