Thursday, September 23, 2021

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AstraZeneca’s COVID-19 vaccines made by Siam Bioscience pass quality testing in Europe and U.S., first batch delivery is near

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AstraZeneca announced today that the samples from test batches of the COVID-19 vaccine made by Siam Bioscience had passed the quality testing at AstraZeneca’s designated laboratories in Europe and in the U.S.

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Mr. James Teague, Country President, AstraZeneca (Thailand) Ltd., said: “We have seen a series of significant and promising progress in AstraZeneca’s COVID-19 vaccine development in Thailand during the past weeks. First, the Thai Food and Drug Administration approved Siam Bioscience as a manufacturing facility for COVID-19 Vaccine AstraZeneca. Last week, the samples of COVID-19 Vaccine AstraZeneca made by Siam Bioscience passed the full tests the standard set by the Department of Medical Sciences (DMS) for requirements such as chemical composition and safety.. And today, I am happy to be able to inform you that the samples from test batches of the COVID-19 vaccine made by Siam Bioscience had passed the quality testing at AstraZeneca’s designated laboratories in Europe and in the U.S. These significant progresses mean that we are getting closer to deliver the first batch of the vaccine to the government of Thailand.”

James Teague

Maintaining quality standards

Numerous safety tests and quality control measures are carried out at each step of manufacturing and distribution. This includes completing all steps in the quality assurance process, with each batch of vaccine undergoing more than 60 different quality control tests during its journey from manufacture to vaccination. To ensure consistent quality across supply chains, AstraZeneca has built an extensive analytical network globally.

In addition, AstraZeneca works closely with the local health authorities such as the Thai FDA, the Department of Medical Sciences (DMS) to ensure local standards are met.

“Our focus is on delivering vaccines as quickly as possible whilst ensuring adherence to the highest safety and quality standards and processes. We will continue to work closely with the government to achieve that. We are well aware that increasing concerns and question have been raised around vaccine safety and the availability of supply to help Thais and the people in Southeast Asia to fight this terrible COVID-19 pandemic. I want to once again reiterate AstraZeneca’s commitment that we are putting science and the interest of society at the heart of our work. And we will remain true to our values by continuing to work with governments and other organizations towards broad and equitable access to the vaccine in a timely manner and at no profit during the pandemic.” said Mr. Teague.

Vaccine access & efficacy

AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorization for emergency use in more than 70 countries, with the World Health Organisation (WHO) Emergency Use Listing now accelerating the pathway to access in up to 142 countries through the COVAX Facility.

Our vaccine is well-tolerated, and highly effective against all disease severities and across all adult age groups, according to data from clinical trials in up to 60,000 participants and emerging real-world evidence from tens of millions of people.

Regulatory authorities in the U.K., European Union, the WHO have concluded that the benefits of using COVID-19 Vaccine AstraZeneca to protect people from this virus significantly outweigh the risks. 

Published : May 09, 2021

By : The Nation