TGA clears Pfizer jab of elderly danger

Australia’s medicines regulator says there is no causal link between the deaths of about 30 very frail elderly people in Norway and the Pfizer vaccine.

The first vials of the Pfizer-BioNtech COVID-19 vaccine will be imported this month. Picture: AFP

Australia’s medicines regulator says there is no causal link between the deaths of about 30 very frail elderly people in Norway and the Pfizer vaccine.

The Therapeutic Goods Administration launched an investigation last month after Norway’s medical regulator reported the deaths of the frail elderly people, many of whom had only weeks or months to live, shortly after receiving the Pfizer vaccine.

The TGA was working with Norway and the European Medicines Agency to establish whether the deaths were caused by adverse reactions following administration of the vaccine.

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

“In addition, wider discussions with regulators in North America, the UK and Europe reached a similar conclusion.

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

The TGA granted provisional approval to the Pfizer vaccine on January 24. The first vials of the vaccine will be imported this month, with vaccin­ations expected to begin late in February.

Despite concluding there was no link between administration of the Pfizer vaccine and risk of death in very elderly people, the TGA urged doctors to proceed with caution before vaccin­ating the very frail. “The data for use in the frail elderly (>85 years) is limited ... the potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis”, it advises.

Svein Andersen, 67, becomes the first person in Norway to receive the Pfizer-Biontech COVID-19 vaccine on December 27. Picture: AFP

The conclusion of the EMA that no causal link was demonstrated with the Pfizer vaccine following the Norway deaths came after the World Health ­Organisation reached a similar conclusion.

The WHO convened a meeting of a subcommittee of its global advisory committee on vaccine safety following the Norway deaths, which examined data from the European Medicines Agency and the Swedish ­Uppsala Monitoring Centre on deaths reported in frail, elderly individuals who had received the vaccine across Europe. “The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2,” that subcommittee concluded.

“Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events.

“The committee considers the benefit-risk balance … remains favourable in the elderly, and does not suggest any revision … to recommen­dations around the safety of this vaccine.”

The WHO subcommittee had access to a trove of real-world data following the vaccination of millions of elderly people with the Pfizer shot in Europe. The TGA said it would continue to monitor the safety of COVID-19 vaccines as they were rolled out in Australia and internationally.

“Australia co-chairs the global regulatory (International Coalition of Medicines Regulatory Agencies) network for safety monitoring of COVID-19 vaccines and therefore has very timely access to international vaccine safety reports,” the regulator said.

“For all approved COVID-19 vaccines, the existing extensive Australia-wide vaccine and medicine safety monitoring system is being scaled up to include the new vaccine.”