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The story behind the new coronavirus vaccine: How did the TGA quickly review the Pfizer vaccine and let us return to normal life?
The COVID-19 epidemic has swept the world, living in unrest, and people are eager to return to normal life. With a COVID-19 vaccine now in development, a crucial step forward is the review process by Australia's Therapeutic Goods Administration (TGA). The agency quickly provided approval for the Pfizer-BioNTech vaccine as soon as the vaccine production was qualified, enabling the country to respond urgently to the epidemic and restore hope to the public.
"While ensuring public safety, accelerating the vaccine approval process will allow us to return to normal life faster."
The role and history of TGA
The TGA is the Australian Government's medicines and therapeutic products regulatory agency, responsible for ensuring the safety, quality and effectiveness of therapeutic products. Since its establishment in 1991, the TGA has established a comprehensive regulatory framework for medical products in Australia, including traditional medicines and biologics, which have grown rapidly in recent years.
Historically, regulation of therapeutic products began with state governments, with negotiations between states to agree on uniform standards. In 1953, the Australian government promulgated the first Federal Therapeutic Products Act, making it the starting point for national medical product regulation. With the evolution of the law, especially the 1966 and 1989 Acts, the TGA's power in reviewing therapeutic products has continued to increase and the relevant legal standards have been further improved.
Vaccine rush: TGA review of Pfizer-BioNTech vaccine
The TGA granted interim approval to the Pfizer-BioNTech COVID-19 vaccine, called COMIRNATY, on January 25, 2021. Approval of the vaccine is limited to people over the age of 16 and requires the vaccine manufacturer to submit further clinical data.
“We must react quickly based on empirical data and scientific evidence to quickly protect the health of society.”
The TGA's previous analysis of the Pfizer vaccine was quite thorough, with ingredients and documentation verified for every batch of all vaccines before being distributed to healthcare facilities. This process shows the importance TGA attaches to vaccine safety, allowing vaccination to be safely promoted on a larger scale. As the first batch of vaccines were officially vaccinated on February 21, 2021, the government set different vaccination priorities for various groups of people and distributed vaccines in large quantities in the following months.
Challenges and deployment of vaccination
The vaccination effort has not been smooth sailing. At the same time as the Pfizer vaccine was administered, the TGA also approved the Oxford-AstraZeneca vaccine. However, due to reports of a few cases of thrombotic reactions, the government made adjustments to the vaccination age and strengthened public understanding and trust.
Every decision made by the TGA closely follows changes in scientific data and expert advice to ensure that Australia, while protecting its people, will not delay the vaccination process because there is not enough vaccine.
Summary
With the rapid rollout and successful vaccination of COVID-19 vaccines, TGA's professional review has not only accelerated the pace of anti-epidemic efforts, but also rebuilt people's trust in vaccines. How does TGA maintain its ability to respond flexibly to emerging therapies in the face of constant technological challenges and market changes?
