Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it the second vaccine to receive regulatory approval in Australia.
Initial supply of this vaccine will be imported into Australia from overseas, however it is anticipated that ongoing supply will be manufactured in Australia.
Prior to the supply of vaccines manufactured onshore, AstraZeneca will submit further information and data to the TGA to confirm that onshore manufacturing will meet strict quality standards.
The approval is valid for two years and the vaccine can now be legally supplied in the country, the TGA said.
The second dose of the vaccine is to be administered from four to 12 weeks after the first.
The approval is given for Australians aged 18 years and older. There were no safety concerns from elderly patients during the vaccine trials.
“Elderly patients over 65 years of age demonstrated a strong immune response (high seroconversion rates) to the vaccine in clinical trials, however there were an insufficient number of participants infected by COVID-19 to conclusively determine the efficacy in this subgroup,” the TGA noted in its approval.
“In this sub-population, efficacy has been inferred from immunogenicity data and efficacy demonstrated in the general population.
“Reassuringly, there were no safety concerns in this age group in the clinical studies, nor in the large numbers of elderly people who have been vaccinated to date in overseas rollouts.”
Rollout an ‘enormous exercise’: PM
Australia’s vaccination strategy is an “enormous exercise”, Prime Minister Scott Morrison has said.
“The vaccines that we have, they address the critical issue of serious disease and indeed, the risk of fatality that can arise from COVID-19,” he said.
“Increasingly we’re seeing positive signs about its impact on transmissibility as well.”
Health Minister Greg Hunt has touted the positive results seen from the AstraZeneca vaccine published in top medical journal The Lancet.
The journal stated the AstraZeneca vaccine offers a 100 percent “protection against severe disease, hospitalisation, and death”.
“What that means is that the vaccine rollout is on track,” he said.
“All of the team at the TGA that have worked extraordinary hours to tick every box, to assess everything, to make sure that safety, safety, safety, is the number one priority.”
‘No indication’ vaccine is unsafe for pregnant women
TGA boss John Skerritt also said there was no indication the vaccine was unsafe for pregnant women.
“If you’re known to be pregnant, you can’t volunteer for a clinical trial. It’s just a safety measure, a precautionary measure,” Prof Skerritt said.
“However, there were a number of people who didn’t know they were pregnant or became pregnant during the trials, and there haven’t been reports of adverse outcomes.”
Of the pregnant women overseas who have since received the vaccine, there has been no indication of a problem.
“Those babies are yet to be born and so forth, again, there’s no evidence of anything untoward such as miscarriage or illness during pregnancy,” Prof Skerritt said.
“As the weeks and months go on, we’ll know a lot more about pregnancy with these vaccines.”