Taiwan COVID-19 vaccines may be too late for US emergency approval

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Taiwan COVID19 vaccines may be too late for US emergency approval

Taiwan’s home-grown Covid-19 vaccines could be restricted to use on the island if the US Food and Drug Administration follows through on a plan to stop reviewing and processing new emergency use authorisation requests.

Both firms have completed phase 2 clinical trials of their vaccines and are seeking local regulators’ EUA approval to market their shots, hopefully in the next few months, according to officials from the two companies. Su said a halt on EUA approvals by the US FDA would also make it difficult for locally developed vaccines to enter the global market, especially as a number of international brand products had already completed their third and final clinical trials and were ready to get full approvals for use in their home countries.

Currently, three Covid-19 vaccines have emergency use approval from the US FDA – the messenger-RNA-based vaccines from Pfizer and Moderna, and an adenovirus-based vaccine from Johnson & Johnson. AstraZeneca from Britain also has discussed plans for its Covid-19 vaccine with US officials. However, The Wall Street Journal earlier this month reported it was considering skipping US emergency-use authorisation in favour of the more time-intensive application for a fully-fledged licence to sell the shot.

The company was also negotiating with Southeast Asian nations in Covid-19 vaccine development and business cooperation projects, Medigen said without naming the countries.

 

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