“The deaths were recorded among very frail patients, including some who were anticipated to only have weeks or months to live,” TGA said in a release on Feb. 2.
Additional research concluded that there was “no specific risk of vaccinations with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.”
TGA’s discussions on the cases at a recent meeting with the European Medicines Agency, Pfizer, wider discussions with regulators from North America, UK, and Europe reached similar conclusions.
“Elderly patients can receive this vaccine, and there is no cap on the upper age limit,” TGA declared.
For frail patients over the age of 85, TGA said the data is limited and should be carefully assessed on a case-by-case basis. The therapeutic authority aims to continue to monitor the safety of COVID-19 vaccines as they are rolled out in Australia and internationally.
Prime Minister Scott Morrison said that the Pfizer vaccine’s approval in Australia is different to other countries because it was a formal rather than an emergency approval.
“We are one of only a handful of countries to have gone through such a comprehensive and thorough level of oversight to ensure the vaccines are safe,” Morrison told the National Press Club on Monday.
“Our aim is to offer all Australians the opportunity to be vaccinated by October of this year, commencing in just a few weeks’ time.”
On Jan. 25, TGA provisionally approved the Pfizer vaccine for two years after a “thorough and independent” evaluation of Pfizer’s submission, concluding that it met the high safety, efficacy, and quality standards required for use in Australia.
Pfizer is the first vaccine to be approved for use in Australia.
For optimal efficacy, patients must take two doses (0.3 ml each) at least three weeks apart, and it must be stored and transported at -70°C (-94°F).
The Australian Government’s total financial support for CCP virus vaccines and treatments has come to $6.3 billion.