16 February 2021
The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.
COVID-19 Vaccine AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The use of this vaccine should be in accordance with official recommendations and given in two separate doses. “TGA’s regulatory approval allows the second dose to be administered from 4 to 12 weeks after the first. The Australian Technical Advisory Group on Immunisation has recommended that the interval between first and second dose is 12 weeks. However if this interval is not possible, for example because of imminent travel, cancer chemotherapy, major elective surgery, a minimum interval of 4 weeks between doses can be used.
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. COVID-19 Vaccine AstraZeneca has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease.
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. 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. The decision to immunise an elderly patient should be decided on a case-by-case basis with consideration of age, co-morbidities and their environment taking into account the benefits of vaccination and potential risks. Further information from ongoing clinical trials and post-market monitoring is expected in coming months. Additional details can be found in the Product Information and Australian Public Assessment Report (AusPAR).
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 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.
AUSTRALIA’S COVID 19 TREATMENT STRATEGY
|The COVID-19 vaccines will be voluntary and free and available to all people living in Australia. The Government aims to have as many Australians as possible choose to be vaccinated for COVID-19. COVID-19 vaccines available as part of Australia’s diversified portfolio will require two doses between three and four weeks or so apart.|
It is understood Australians are likely to get sent the information directly or through their GP when it is their turn to get the COVID vaccine, with a national public health campaign to alert Australians when the rollout moves into its different phases.
Other details in the plan include:
- A national front door booking system so people can book directly with a GP clinic or pharmacy once contacted
- As the rollout is primarily based on age, most people will only need to show their driver’s license to show they are eligible
- Healthcare providers will email through a certificate which can be printed out once a person is inoculated
- The medical provider will upload details of who has had a vaccine to the person’s Australian Immunisation Register, which records all vaccines given to people in Australia
- Authorities will set up a national database and any side effects or adverse events, if they occur, will be made public
Click HERE for the Australian Government Health website.
Government Services Minister Stuart Robert said anyone who received a coronavirus vaccine would have it recorded on the Australian Immunisation Register.
The record will then be made available on the MyGov website, the Express Plus Medicare app, where a person’s total immunisation history is listed, or a paper version can be printed out.
Click HERE to see how CSL plans to make a million COVID-19 vaccines a week in Australia.
ON TV: ABC News – The Vaccine – Friday 7:30 PM – 8:00 PM [30 mins] – Jeremy Fernandez is joined by experts including Dr Norman Swan, Casey Briggs and Sophie Scott to bring you everything you need to know about the rollout of the COVID-19 vaccine and to answer your questions.
E-MAIL – THE TRAVELLERS HUT – Complete the form and click submit