Manufacturing of vaccines approved
Siam Bioscience, which is owned by the Crown Property Bureau, has been chosen by the Thai Food and Drug Administration (FDA) to manufacture the vaccines. AstraZeneca said that it and Siam Bioscience have been working tirelessly to ensure safe and timely delivery of vaccines to inoculate the Thai population.
Production of the vaccine is critical not only to Thailand’s fight against the virus but also to the eight other countries in Southeast Asia the vaccines will be exported to.
The plant has passed the Good Manufacturing Practice (GMP), a system ensuring that products are consistently produced and control. Siam Bioscience’s plants have also earned several 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 inoculation.
James Teague, president of AstraZeneca (Thailand), said: “AstraZeneca and our global manufacturing partners, including Siam Bioscience, are committed to maintaining 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 Thailand.”
Regional production hub
“Thailand will play a key role in supporting our neighbours in Southeast Asia to combat Covid-19,” Teague said.
“We all have the same objective, to get effective vaccines to everybody as quickly as possible but safely.
“The AstraZeneca vaccine is safe and can save many lives as it has 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 vaccine.
“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,” Teague added.
AstraZeneca’s Covid-19 vaccine has been granted conditional marketing authorisation 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.
The AstraZeneca vaccine is 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 per cent after the first dose.
Regulatory authorities in the UK, European Union, the WHO have concluded that the benefits of using the vaccine to protect people from this virus significantly outweigh the risks.
Published : April 28, 2021
By : The Nation