TTY Biopharm Co Ltd (台灣東洋藥品) yesterday said it has gained Bio-NTech SE’s authorization to sell its mRNA-based COVID-19 vaccine in Taiwan, and the supply of vaccine is expected to total 30 million doses next year.
Having received a letter of authorization from the German firm, TTY said it would apply for marketing approval of the vaccine candidates from the Food and Drug Administration (FDA).
The candidates are being tested around the world under phase 2 and 3 clinical trials, it said.
Photo: CNA
If the FDA approves BioNtech’s vaccine candidates, TTY said that it would negotiate with the agency over the number of doses it would buy and the price of the vaccine — after BioNTech reviews the deal, TTY spokesman KC Chang (張國江) said by telephone.
Given that BioNTech’s clinical trial for its candidate BNT162b2 is being conducted in several countries, including the US, Brazil, South Africa and Argentina, but not in Taiwan, TTY would discuss with the FDA to see if it needs more clinical data or a supplementary local test as it reviews vaccine candidates, Chang said.
“The global trial enrolled approximately 36,576 participants earlier this month, of whom 4 percent are Asian. That might help the biotech company test if its vaccine candidates also work on Asians,” Chang said.
The FDA might not request an additional local test on the vaccine candidate, as the agency has accepted foreign influenza vaccines that were not tested domestically, such as Australia-based Seqirus Inc’s vaccines, TTY said.
“We would finalize the details in negotiations over the next few months,” Chang said.
A total of 30 million doses of BioNTech’s mRNA-based vaccine would be enough for 15 million people, as each person would need to receive two shots, Chang said.
The first 10 million doses are expected to be delivered in the first quarter of next year, he said.
All of the vaccine that it purchases would be produced by BioNTech in Germany, he added.
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