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AstraZeneca Vaccine Receives FDA Approval


Published: Январь 22, 2021 at 8:55 дп
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The COVID-19 jab by the British pharmaceutical firm AstraZeneca has received approval from the Food and Drug Administration for emergency use in Thailand. The company then added that it will be shipping 50,000 doses of the drug by the end of February.

According to the FDA, they had received AstraZeneca’s application for emergency use last December 22. The application included 10,000 pages of documents including results of the clinical trials, which the agency had to study for nearly 30 days before they gave the approval on Wednesday.

FDA secretary-general Paisarn Dunkum said that they had diligently studied the documents with a focus on determining the efficacy and safety of the vaccine.

The company will be shipping a total of 50,000 doses to Thailand next month. The remaining 150,000 doses under the agreement will be arriving in March and April, respectively.

The FDA Secretary-General assured the public that the Department of Medical Sciences will be conducting a prior examination of the doses when they arrive in order ascertain its safety when inoculated to people.

Although it was reported that Siam Bioscience will be producing the vaccine locally, reports indicate that the approval for emergency use has been granted only to doses of the vaccine that had been manufactured overseas.

Dr. Paisarn explained that Siam Bioscience will only be able to roll out its first batch of vaccines in May.

This procurement of 200,000 doses from AstraZeneca is a deviation from the government’s initial procurement plan, which involved the delivery of 2 million doses of the Sinovac vaccine in three batches arriving in February, March and April.

The locally produced vaccine by Siam Biotech under license from AstraZeneca will then be made available by May. The government had announced that 26 million doses of the vaccine will be available through this procedure.

Authorities had not made a single mention of importing 200,000 doses of the AstraZeneca drug up until the approval of the FDA for emergency use.

Progressive Movement leader Thanathorn Juangroongruangkit criticized the government’s procurement plan in a Facebook Live on Monday.

Mr. Thanathorn said that the govenrment’s procurement efforts had been “too slow” and is insufficient to cover the majority of the population. He also added in a press conference on Thursday that the vaccination plan will cover only 21.5% of the population.

“Efforts are also being made with cabinet approval to buy more from AstraZeneca, but procurement details are still not clear,” he told reporters at the Thai Summit Tower building.

He also criticized the singular choice of AstraZeneca, and the agreement to produce the vaccine locally via transfer of technology between the UK firm and Siam Bioscience Ltd.

In response, National Vaccine Institute director Nakorn Premsri said that AstraZeneca had chosen Siam Bioscience out of trust, and not-for-profit principles had applied when signing the contract.

The Digital Economy and Society Ministry had filed a lawsuit against Mr. Thanathorn on Wednesday slapping him with lese majeste charges over his comments on the government’s vaccination plan. The opposition leader describes this lawsuit as an effort to “silence” him.

Sources:
BangkokPost
BangkokPost


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