Taiwan Covid-19 vaccines may be too late for US emergency approval
- Former health official flags competition problems for home-grown shots as global brands complete phase 3 clinical trials
- Two locally produced vaccines have finished phase 2 trials and are expected to be marketed on the island in the next few months
Taiwan’s Central Epidemic Command Centre has ordered 10 million doses of vaccines from two local developers – Medigen Vaccine Biologics and United Biomedical – with an option of buying 10 million more amid a recent Covid-19 outbreak that saw 135 new infections and eight deaths on Tuesday.
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.
But their vaccines could end up being marketed only in Taiwan, as the US FDA has suggested it may no longer issue EUA for new vaccine candidates, according to Su Ih-jen, former director general of the Centres for Disease Control.
“The outbreak in the US has stabilised and the vaccines developed by American companies are in abundance, meaning the US FDA does not have the need to approve EUA for vaccine candidates from other countries,” he said.
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All eyes on Taiwan’s home-grown vaccines as 2 local developers await emergency approval
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.
