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Taiwan's Medigen not on US list of approved vaccines for Nov. 8

Starting Nov. 8, Taiwanese flying to US must be vaccinated with FDA, WHO-approved vaccines

Taiwan's Medigen not on US list of approved vaccines for Nov. 8

(CNA photo)

TAIPEI (Taiwan News) — Starting on Nov. 8, all foreign travelers to the U.S., including Taiwanese, must be fully vaccinated with a COVID-19 vaccine from a list of approved brands — but Taiwan's domestic vaccine developed by Medigen Vaccine Biologics Corp. (高端疫苗, MVC) has not been included.

On Monday (Oct. 25), the White House announced that effective Nov. 8, "non-citizen, non-immigrant" air travelers to the U.S. must be fully vaccinated and provide proof of inoculation prior to boarding a flight to the country. Unvaccinated American citizens and lawful permanent residents must take a COVID test one day before departure, while vaccinated ones will need to present proof of a negative test taken within three days of departure.

The new regulations will replace the travel ban imposed on 33 countries, including China, India, the United Kingdom, and Europe's Schengen Area, during President Donald Trump's term in office. The new requirements will apply to all countries, including Taiwan, citizens of which currently enjoy unlimited travel to the U.S.

The list of recognized vaccines is based on those approved by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The vaccines that have received FDA emergency use authorization (EUA) or full approval include Pfizer-BioNTech, Moderna, and Janssen (J&J), while the WHO has also provided emergency use listing for (EUL) for these vaccines as well as AstraZeneca, Sinopharm, and Sinovac.

The U.S. will also recognize any two-dose combination of vaccines approved/authorized by the FDA or WHO. Groups exempt from the vaccine regulation include children under the age of 18, for whom a pre-departure test is required instead unless they are with a fully vaccinated adult, in which case they have three days to be tested for the virus.

When asked whether the U.S. would consider including vaccines that are not on the WHO's EUL, a senior official was cited by CNA as saying that, "I'm afraid the probability is not high." The official said that the United States chose the FDA and WHO-approved lists because these vaccines have gone through easy-to-define internationally recognized standard procedures.

The official emphasized that the WHO and its Strategic Advisory Group of Immunization Experts (SAGE) regularly review the EUL and will go through a review process in the future when other specific vaccine efficacy data is released.

There are some signs Medigen could eventually receive approval from the WHO. A consent form appeared on the agency's website on Oct. 20 listing the jab among the four latest COVID vaccine candidates in the organization's Phase III Solidarity trial.