Australian Public Assessment Report for BNT162b2 (mRNA)

The evaluation of the Comirnaty vaccine was significantly expedited without compromising the TGA’s strict standards of safety, quality and efficacy. This was facilitated through rolling data submission, and through collaboration with international regulators. The provisional determination for the Pfizer-BioNTech COVID-19 vaccine, BNT162b2 (mRNA) was granted by TGA on 14 October 2020. Facial paralysis: there were Read More …

Basic Concept of Vaccination

The word “vaccine” originates from the Latin Variolae vaccinae (cowpox), which Edward Jenner demonstrated in 1798 could prevent smallpox in humans. Today the term ‘vaccine’ applies to all biological preparations, produced from living organisms, that enhance immunity against disease and either prevent (prophylactic vaccines) or, in some cases, treat disease (therapeutic vaccines). Vaccines are administered Read More …

Gardasil Vaccine ~ Australian Public Assessment Report for: Quadrivalent human papilloma virus.

Carcinogenicity GARDASIL has not been evaluated for carcinogenic potential. Genotoxicity GARDASIL has not been evaluated for genotoxic potential. Paediatric Use The safety and efficacy of GARDASIL have not been evaluated in children younger than 9 years.   Use with Other Vaccines Results from clinical studies indicate that GARDASIL may be administered concomitantly (at a separate Read More …

Enhanced school-based surveillance of acute adverse events following immunisation with human papillomavirus vaccine in males and females, 2013

Australia was the first country to introduce a government-funded National Human Papillomavirus (HPV) Vaccination Program for females. From 2007 to 2012, the TGA captured national adverse event reports via routine passive surveillance. In 2013, the National Immunisation Program (NIP) schedule was extended to include males (12 to 13 years as standard and a two year Read More …

Are Pfizer conducting unauthorised human experiments?

Health Ministry: ‘It’s not an experiment’ ‘It’s an aggregate information-sharing agreement with Pfizer,’ Health Ministry responds to Helsinki Committee report.   The Health Ministry tonight responded to reports that the Helsinki Committee for Human Rights is expected to announce that Pfizer is conducting unauthorized human experimentsin Israel. In a statement, the Ministry said “in an Read More …

ProQuad Vaccine Insert

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. Vaccine-related adverse reactions reported during clinical Read More …