On January 27, 2022, the TGA expands Pfizer’s COVID-19 vaccine booster dose provisional registration to now include 16-17 years of age. [1]
“The TGA continues to monitor ongoing trials associated with booster doses for younger children.
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.”
On the same day as this approval the TGA stated in their weekly report that “[t]he TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines. This is the most intense safety monitoring ever conducted in Australia.
We encourage people to report suspected side effects, even if there’s only a very small chance a vaccine was the cause. This provides valuable data that helps us identify potential safety issues. Often, however, these events are not caused by the vaccines.”
Post-vaccine adverse events the TGA are currently monitoring include:
- myocarditis and pericarditis (mRNA vaccines, particularly in younger age groups)
- thrombosis with thrombocytopenia syndrome (TTS) following Vaxzevria (AstraZeneca)
- Guillain-Barre Syndrome (GBS) following Vaxzevria (AstraZeneca)
- immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca)