‘Critical risk’: push for vaccine safety office

A new independent immunisation safety office should be established as part of an overhaul of the vaccine monitoring and response systems, a leading expert says.

The call for an independent immunisation safety office sustained complaints from Australians who suffered rare but serious side effects linked to their Covid vaccination that there has been little official follow-up or investigation of their cases.

A new independent immunisation safety office should be established as part of an overhaul of Australia’s vaccine monitoring and response systems, a leading expert says.

Professor Nick Wood, Professor of Clinical Vaccinology at the University of Sydney, said the new office could be independent of the federal health department, which funds the national immunisation program, and separate to the Therapeutic Goods Administration, the regulator responsible for vaccine registration. The TGA derives most of its funding through fees and charges on the pharmaceuticals industry.

Professor Wood has also recommended that long-term follow-up of people who suffer a severe reaction to their immunisation should be a routine part of the vaccine surveillance system.

“Short and long-term clinical follow-up of serious conditions is neither systematic nor routine in Australia. This means that long-term outcomes, risk factors and causes of serious adverse events following immunisation is poorly understood,’’ he said.

Professor Wood’s report was part of a Churchill Fellowship study of some of the world’s leading vaccine safety and clinical vaccine research units.

It follows sustained complaints from Australians who suffered rare but serious side effects linked to their Covid vaccination that there has been little official follow-up or investigation of their cases, leaving many in limbo.

“It is important that we have sufficient knowledge to be able to tell a person who had an adverse event after a vaccine what the long-term outcomes are likely to be and whether it is safe to have another vaccine,’’ Professor Wood said.

His report comes days after a class action was lodged in the Federal Court alleging the TGA was negligent in its approval and monitoring of Covid-19 vaccines. The TGA says on its website that suspected side effects are closely monitored: “This is the most intensive safety monitoring ever conducted of any vaccines in Australia.”

The lawsuit is seeking greater access to compensation for people who suffered a severe adverse reaction.

A limited compensation scheme exists in Australia for people seriously injured by a Covid vaccine but Professor Wood said this should be expanded to include all vaccines on the immunisation register, and could be funded by a vaccine excise tax on pharmaceutical companies.

While there is no doubt that immunisations save lives, they carry a small risks of serious side effects and Professor Wood said as new types of vaccinations come online, strong systems should be in place to ensure public safety and confidence.

“As these technologies are new there is a need to improve our understanding of their real-world safety and effectiveness in all members of our community. The potential emergence of unforeseen adverse reactions related to these new technologies, offsetting the anticipated benefit of vaccines, is a critical risk,’’ he said.

Professor Wood, the associate director of clinical research and services at the National Centre for Immunisation Research and Surveillance, said the new immunisation safety office (ISO) should be embedded in the planned Centres for Disease Control, which is due to open next year to improve Australia’s preparedness and response to public health emergencies.

“If Australia is to have a national immunisation safety office, the model needs to be discussed. We would want to have that debate including with the TGA, and the state and federal governments,’’ he said.

“In the US, it’s embedded within the CDC, which has its advantages. Or it could be a completely separate and independent authority.”

He said it could build upon and link Australia’s comprehensive vaccine safety system that involves the TGA, which collates reports from all states and territories, the surveillance system AusVaxSafety, and a national network of clinicians who collaborate on serious adverse events linked to vaccination.

Currently, these systems function independently of each other with no overall co-ordination. “One of the benefits of having a national ISO in Australia would be the overall co-ordination of safety activities, comprehensive surveillance and identification of gaps in safety knowledge to inform and enable research.”

He also recommended that a national consortium of clinical vaccine trial sites should be established within the CDC to conduct vaccine trials.

Canberra man Rado Faletic, who helped found Coverse, a support group for people injured by Covid-19 vaccines, said he would support the implementation of Professor Wood’s recommendations so long as they led to real help for patients.

“We hold Nick in high regard. He’s one of the few experts in this area who is taking our concerns seriously and is doing what he can to effect better patient outcomes,’’ Mr Faletic said.

“We particularly support the recommendations about establishing a vaccine safety body that is completely independent from the TGA and making ongoing follow-up a routine part of the system.

“However, even if all of Nick’s recommendations are implemented, we maintain reservations about how this will improve much for patients.”