FDA secretary-general Paisarn Dunkum said on Thursday (Jan 21) that the FDA approved the registration of the vaccine, produced in Italy by AstraZeneca Co, on Wednesday after the firm had submitted nearly 10,000 pages of its documents for vaccine registration for emergency use on Dec 22 last year, reports the Bangkok Post.
The FDA had examined the documents by taking into consideration the efficacy and safety of the COVID-19 vaccine, said Dr Paisarn.
A total of 50,000 doses of the vaccine will arrive in Thailand in February. The import licence and vaccine registration will be valid for one year. A Reuters source said the approval applied only to doses manufactured overseas.
Mr Paisarn added the Department of Medical Sciences will randomly examine the vaccine for its efficacy and safety before it can be used on people.
AstraZeneca, a British-Swedish multinational pharmaceutical and biopharmaceutical company, will gradually deliver the remaining 150,000 doses of the vaccine to Thailand in March and April, said the FDA secretary-general.
As for the production of the AstraZeneca vaccine by Siam Bioscience, the vaccine produced by the local firm could be available for use in May, he said.
The announcement by the FDA of the availability of 200,000 doses of the vaccine came as a surprise since it was not on the procurement plan unveiled by the government earlier.
Under that plan, the first type of vaccine Thais will use is Sinovac from China-based Sinovac Biotech, which will ship 2 million doses from February to April. Another 26mn doses of AstraZeneca vaccine made locally by Siam Bioscience Co Ltd will be available in the second half.
Up until now, there was no mention of the imported 200,000 doses of AstraZeneca vaccine in briefings by authorities.