Australia’s regulator has approved the AstraZeneca vaccine, ending months of delay to give full approval while other countries begin vaccinations with emergency approvals.
The head of the Therapeutic Goods Administration, John Skerritt, told reporters in Canberra it had placed no upper age limit on use of the AstraZeneca vaccine because it had “no reason to suspect” it won’t be fully effective in older age groups.
The health minister, Greg Hunt, declared the AstraZeneca vaccine was “cleared for liftoff”, just a day after the first batch of 142,000 Pfizer vaccines arrived in Australia for a vaccination program to launch on Monday.
The TGA approval advises a second dose to follow 12 weeks after the first AstraZeneca jab, which Skerritt said raises its effectiveness to 82% protection against contracting Covid-19.
Skerritt rejected suggestions the AstraZeneca vaccine materially lagged earlier promises of 90% effectiveness. He said such comparisons were “not particularly relevant” because there was “no difference in the real world” in the degree of protection between 82% and 90%. The Pfizer vaccine prevents up to 95% of people contracting coronavirus.
The AstraZeneca vaccine displayed “100% efficacy against severe disease, illness and death”, he said.
“What is important is to get vaccines into people’s arms.
“AstraZeneca gives us a vaccine that can be used in major facilities, in primary care through GPs potentially through pharmacy practices.”
The AstraZeneca vaccine will be central to Australia’s rollout both because it does not need to be stored at -70C and it will be domestically produced, ramping up to 1m doses per week by late March.
On Monday Hunt recommitted the government to its target of providing 4m vaccinations by April, and on Tuesday to provide at least the first dose to everybody who wants one by October.
The 12-week gap between AstraZeneca vaccinations “means that more Australians will have more vaccines earlier”, Hunt said. “That’s a happy byproduct of the decision.”
In its provisional approval decision, the TGA said patients over 65 had “demonstrated a strong immune response” to the AstraZeneca vaccine in clinical trials, although there were “an insufficient number of participants infected by Covid-19 to conclusively determine the efficacy in this subgroup”. Instead, efficacy was inferred from immune response.
The decision said giving the vaccine to elderly patients should be done on a case-by-base basis, which Skerritt explained was to avoid “futility” of treating those with “weeks to live”. “We recommend that older people should get the AstraZeneca vaccine.”
In January, concern in the Pfizer vaccine was driven by cases of death in Norway which were later attributed to co-morbidities and extreme old age.
Asked if the federal government regrets seeking a slower vaccine approval, which has resulted in periodic outbreaks from hotel quarantine including one that sparked the current five-day lockdown in Victoria, Scott Morrison denied the premise of the question.
“There has been no slow approval process,” the prime minister said. “This has been, I think, the most efficient and timely process that the TGA has ever undertaken for any vaccine.”
Australia has opted for full approval to maintain public confidence in vaccines and it was important that regulators “cut no corners”, Morrison said.
The first 1.4 million vaccine recipients will be quarantine and border workers, frontline healthcare workers, aged care and disability staff and residents – who will be given either the Pfizer or AstraZeneca vaccines.
After the first priority group, the next group to be vaccinated will be adults aged over 70, healthcare workers, Aboriginal and Torres Strait Islander people over 55, younger adults with underlying medical conditions, emergency services and meat processing workers.
The next three groups are: adults aged 50 to 69 and Aboriginal and Torres Strait Islander people 18 to 54; the rest of the adult population; and, lastly, children under 16 if appropriate.
This content first appear on the guardian