CORONAVIRUS/Medigen applies for COVID-19 vaccine EUA in Eswatini

10/13/2021 10:29 PM
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CNA file photo
CNA file photo

Taipei, Oct. 13 (CNA) The Taiwan-based Medigen Vaccine Biologics Corp. said Wednesday it has filed for emergency use authorization (EUA) for its COVID-19 vaccine in Eswatini.

In an announcement posted on the Taipei Exchange, where Medigen shares are traded, the vaccine developer said it was seeking EUA from the Ministry of Health in Eswatini, one of Taiwan's 15 diplomatic allies.

On July 19, the Medigen vaccine became the only locally developed vaccine to receive EUA from Taiwan's Food and Drug Administration (FDA) after an expert panel voted in favor of the move.

The decision was criticized by some, however, as Medigen has yet to complete Phase 3 trials, which are normally required for determining the efficacy of a vaccine.

The FDA said it had granted EUA because the neutralizing antibodies generated in Medigen recipients compared favorably to those inoculated with AstraZeneca's COVID-19 vaccine, a concept known as immunobridging.

Taiwan started its rollout of the Medigen vaccine on Aug. 23.

On Oct. 7, Palau confirmed its recognition of the Medigen vaccine, with travelers that have received two shots of Medigen now able to enter the Pacific island nation.

Days before Palau's recognition, New Zealand announced on Oct. 3 that it had added Medigen to its list of approved COVID-19 vaccines.

In addition to Medigen, a total of 22 brands are currently accepted under New Zealand's regulations, including the AstraZeneca, Pfizer/BNT and Moderna vaccines received by the majority of those in Taiwan.

(By Han Ting-ting and Frances Huang)

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