Australian children as young as 12 will soon be eligible to get a third COVID-19 jab following a decision by the medical regulator. Meanwhile, one senator has questioned the regulator over their approval process during a Senate Estimates hearing.
In provisionally approving the Pfizer jab as a booster for the age group, a spokesperson from the Therapeutic Goods Administration (TGA) said the regulator had rigorously reviewed overseas vaccine data.
“Regulatory approval of the booster dose for this age group has also been granted in Israel, the United Kingdom, and the United States,” he said.
“The TGA continues to work very closely with international regulators to align regulatory approaches, share information, and, where it speeds up evaluation, collaboratively review COVID-19 vaccines and treatments.
“Australians can be confident that the TGA’s review process for this vaccine was rigorous and of the highest standard,” he said.
The Australian Technical Advisory Group is expected to give the final approval for the jab to be used as a booster for the age group within days.
The booster had previously been expanded to those 16 and over in January.
The regulator said it will actively monitor the safety of the vaccine in all age groups both in Australia and overseas as a precaution and take action if concerns are identified.
“Your office obtained de-identified clinical data, patient data from the COVID-19 vaccine trials. And did that data form your decision on the vaccine, or did you just accept what the manufacturer said?” Roberts asked Dr. John Skerritt, the national manager of the TGA.
“So Senator, of a long established process is that we receive an aggregate submission looking at the analysis of a patient data,” Skeritt responded.
He added that in doing their review, clinicians and an advisory committee review the data and “we do go back and ask a series of questions to the company, but of the global regulators, only the U.S. Food and Drug Administration (FDA), obtains individual patient data as a course of practise.”
“So the answer is no?” Roberts said.
“So we do not obtain individual patient regulator,” Skerritt replied. “We’re simply not resolved to do so.”
In response to Roberts’ probing questions, Skerritt said the TGA spent many “person months” reviewing the data provided by Pfizer and other U.S. vaccine manufacturers but that there was no requirement to conduct clinical trial testing on their efficacy in Australia.
“If it were a requirement we’d have far fewer medicines and vaccines on the market,” Skerritt said. “We look for trials done in comparable populations. So we assume a trial done on an American is [going to] be transferable to the Australian population.”
He also said that the batch testing done in Australia was to look at safety in an “post market sense,” testing the vaccines’ composition and to make sure there are no contaminants in them.
“The data from FDA and Safety comes from clinical trials that are being conducted globally. And I would add the same approach is accepted by all world’s major regulators, including Europe. So the European Medicines Agency, which regulates for European Union does not require trials to be done within Europe,” Skeritt said.
Roberts asked whether Skerritt was aware of “major concerns” about the FDA’s processes and alleged conflicts of interest with pharmaceutical companies.
In response, Skerritt emphasised that the TGA does not automatically accept all FDA decisions in the United States and instead makes “independent sovereign evaluations of vaccines.”
He also noted that the regulator checks the composition of its advisory groups of experts for conflicts of interest, and promised to provide the Senate committee information on that process without naming the experts.
As of April 8, almost 70 percent of Australia’s eligible population 16 and over had received a booster shot.
Currently, fourth doses are being rolled out for the elderly and vulnerable, such as older Indigenous Australians, those in aged care and disability care, and the immunocompromised, ahead of winter.