TGA finds Pfizer coronavirus vaccine poses no ‘specific’ risk to elderly patients – 2021.2.3

The Therapeutic Goods Administration says the Pfizer-BioNTech COVID-19 vaccine poses “no specific risk” to older patients, after concerns were raised by Norwegian officials following a number of deaths in aged care.

Officials in Norway issued a warning last month after the country recorded a small number of deaths among older people who received the vaccine and suffered side effects.

About 30 people in the country died after receiving the vaccine and experiencing side effects.

All were patients in nursing homes and were older than 80.

At the time Australian authorities said they would seek more information about the issue.

When the TGA approved the vaccine last week it did not set an upper age limit on people who could get the jab and has released a statement directly addressing the concerns from overseas.

It said it had been working closely with the European Medicines Agency and Pfizer on further investigations.

“The case reports were discussed at a recent meeting of the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee, which concluded that there was not a specific safety concern, and no causal link between vaccination and deaths could be established,” it said.

“The TGA therefore has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

“Elderly patients can receive this vaccine and there is no cap on the upper age limit.”

It said as well as the EMA meeting, talks with North America, the United Kingdom and Europe “reached a similar conclusion”.

The Federal Government has bought 10 million doses of the vaccine, which is set to be rolled out in Australia at the end of the month, with frontline health and quarantine workers and people in aged care first in line.

The TGA is also currently considering approval of the Oxford University-AstraZeneca vaccine, of which the Government has secured 51 million doses.

“The TGA will continue to monitor the safety of COVID-19 vaccines as they are rolled out in Australia and internationally,” it said.