The Food and Drug Administration of Thailand has approved Siam Bioscience as a manufacturing facility for COVID-19 Vaccine AstraZeneca.
AstraZeneca’s plans to produce its COVID-19 Vaccine in Thailand has made significant progress and the first batch of the vaccine will be ready for delivery to the Thailand Government in June of this year.
The Food and Drug Administration (FDA) of Thailand has approved Siam Bioscience as a manufacturing facility for COVID-19 Vaccine AstraZeneca. The Company, together with Siam Bioscience, has been working tirelessly to ensure that the facility is on track to safely deliver supply to support the national vaccination campaign. The collaboration with the Thailand Government and the FDA has facilitated the swift but careful progress with the manufacturing plant over the past few months.
In addition, the Thailand vaccine production facility, critical to not only the Thailand Government’s fight against the pandemic but also to the other eight Southeast Asian countries the plant will export to, has passed the Good Manufacturing Practice (GMP), a system ensuring that products are consistently produced and controlled according to quality standards. The company’s plants also achieved multiple international standards such as ISO9001, ISO17025, and ISO13485.
Each batch of the vaccine undergoes more than 60 different quality control tests during its journey from manufacture to vaccination. The process takes time, and it is designed to assure every person who is given the vaccine that it is of the same high quality that can be expected from any AstraZeneca product.
James Teague, Country President, AstraZeneca (Thailand) Ltd. said: “AstraZeneca and our global manufacturing partners, including Siam Bioscience, are committed to maintain the highest safety and quality standards of our products. Numerous safety tests and quality control measures are carried out at each step. We are working as quickly as possible to supply the vaccine to the Government of Thailand to overcome the on-going pandemic.”
“Thailand will play a central role to support our neighbours in Southeast Asia to combat COVID-19, together we can hold hands to fight this pandemic,” said Teague.
Siam Bioscience is critical to support AstraZeneca’s goal of creating and providing broad, equitable and timely access of this vaccine to Southeast Asia. This is the only facility dedicated to providing vaccines to eight other countries in the region. Teague added: “We all have the same objective, to get effective vaccines to everybody as quickly as possible but safely. At the core of everything we do is the health and well-being of the Thai people.
“The AstraZeneca COVID-19 vaccine is safe and can save many lives as it has a very high efficacy, it is easy to transport and store. Patient Safety is the highest priority for AstraZeneca. Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes our COVID-19 Vaccine AstraZeneca,” said Mr Teague.
“Much work is ahead of us in Asia and elsewhere, as we continue to deal with the terrible pandemic and the roll out of vaccination programmes. AstraZeneca has an important role to play, and our intent remains to do that fairly and equitably at no profit during the pandemic around the world.”
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.
COVID-19 Vaccine AstraZeneca has been shown to be well tolerated and highly effective against all disease severities across all adults in clinical trials, and emerging real-world evidence from tens of millions of people also shows that the vaccine reduces severe disease and hospital admissions by more than 80% after the first dose.
Regulatory authorities in the UK, 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. [APBN]