TGA provisionally approves AstraZeneca's COVID-19 vaccine
Following a thorough review process, informed by expert and independent advice from the Advisory Committee on Vaccines (ACV), the TGA has granted provisional approval for the University of Oxford/AstraZeneca COVID-19 vaccine.
Provisional registration will allow COVID-19 Vaccine AstraZeneca to be administered to individuals 18 years and over for the prevention of COVID-19 disease caused by SARS-CoV-2. The 2 dose course may be administered with a 4-12 week interval, with ATAGI preferring doses separated by 12 weeks. In certain circumstances an interval of 4 weeks is acceptable.
Of note, there were no safety concerns revealed in clinical trials involving patients >65 years of age and a strong immune response was demonstrated. However due to insufficient numbers of participants infected with SARS-CoV-2 in this age group, efficacy could not be conclusively determined. As a result, the immunisation of individuals in this age group should be decided on a case-by-case basis.
Supply of this vaccine will initially be imported from overseas, with ongoing supply of vaccines to be manufactured in Australia.
To read the press release in full follow the link below:
TGA provisionally approves AstraZeneca's COVID-19 vaccine
Building a stronger Australian Immunisation Register
A change in legislation, making it a requirement for all vaccination providers to report every vaccine to the Australian Immunisation Register (AIR), has passed through Parliament.
This will allow for a more comprehensive reporting of immunisation data to help enhance vaccination coverage rates and monitor the effectiveness of Australia's immunisation program.
Every COVID-19 vaccine administered within Australia must reported to AIR. From March 1, 2021 every Influenza vaccine must be included and all other NIP vaccines must be reported from July 1, 2021.
To understand more about the new legislation please refer to the press release below:
Building a stronger Australian Immunisation Register
BBC- Covid: New Oxford vaccine 'ready by the autumn' to tackle mutations
With the emergence of various mutations of SARS-CoV-2 there is still reassuring evidence that existing vaccines are providing good protection, although at a slightly less rate than with the initial variants. Additionally, interim results released by the Oxford/AstraZeneca team showed that vaccination with the Oxford/AstraZeneca COVID-19 vaccine could cut transmission of the virus by up to 67%.
In the following article published in the BBC, Professor Andy Pollard from Oxford University suggests that updating vaccines to make them more effective against mutations is a quick process. With manufacturing processes already established, newer vaccines could be available relatively quickly.
To read more follow the link below:
BBC- Covid: New Oxford vaccine 'ready by the autumn' to tackle mutations
New immunisation reference page: Drive-through immunisation clinics
Drive-through immunisation clinics are an alternative venue for supporting vaccine delivery and can assist members of the community to continue to receive recommended immunisations whilst maintaining physical distancing.
Our new reference page highlights the equipment, staffing and logistics to consider when setting up a drive-through clinic.
To access this resource please visit our Immunisation References or follow the link below:
MVEC: Drive-through immunisation clinics
Latest monitoring data confirms safety of COVID-19 vaccines
Data from the UK's independent medicines regulator (MHRA) has confirmed that the safety profile of the approved COVID-19 vaccines (Oxford Astra/Zeneca and Pfizer/BioNTech) remains as high as reported in the clinical trial data that supported those approvals.
With over 10 million doses already delivered, there have been 22,820 reports of suspected side effects with the majority being short-lasting, mild and expected side effects including sore arms and 'flu-like' symptoms.
To read the press release in full follow the link below:
Latest monitoring data confirms safety of COVID-19 vaccines
CVU Miniseries event February 8, 2021- registration closing soon
COVID-19 vaccines: A Victorian landscape is the first event in our CVU Miniseries for 2021.
Please join us online on Monday the 8th of February at 7pm to hear about COVID-19 vaccine safety and Victorian COVID-19 vaccine rollout information.
To view the full program and to register, please visit our Event page.
Registrations for this FREE event will close on Monday the 8th of February at 2pm.
A recording of COVID-19 vaccines: A Victorian landscape will be accessible on our Education Portal following the event.
JAMA Pediatrics: Assessment of Maternal and Neonatal Cord Blood SARS-CoV-2 Antibodies and Placental Transfer Ratio
A recent cohort study conducted at Pennsylvania Hospital, Philadelphia involving 1714 participants assessed maternal and cord blood for the transfer of SARS-CoV-2 antibodies. Trial participants were from various ethnic backgrounds with ages ranging from 28-35 years. IgG and/or IgM was detected in 83 woman at the time of delivery and IgG was detected in the cord blood of 72 of the 83 infants. The transfer of antibodies occurred after symptomatic and asymptomatic infections during pregnancy.
To read the article in full refer to the link below:
December 2020 CVU recording is now available via our Education Portal
Our December CVU covered topics such as COVID-19 vaccines, influenza, vaccine safety and vaccine communication. A recording of this event is now available for viewing.
To access this recording please sign in to our Education Portal and follow the prompts.
Please note that if you have not visited our new Education Portal, you will need to sign up to access content.
MVEC eLearning: Use of Multi-Dose Vials
MVEC are excited to launch the next of our eLearning packages. Our eLearning packages are designed to allow immunisation providers consolidate and evaluate their technical skills. Targeted resources are available to assist with our eLearning and a certificate of completion will be made available upon completion of the corresponding eLearning quiz.
Use of Multi-Dose Vials has been designed to demonstrate the safe preparation and storage of vaccines from multi-dose vials that require reconstitution and from those that do not.
You can access Use of Multi-Dose Vials via our Education Portal.
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
Novavax have released interim results for both its UK phase III clinical trial as well as for the phase 2b studies being conducted in South Africa.
The UK phase III clinical trial involves more than 15,000 participants aged 18-84 years. During a period of high transmission with the UK variant of SARS-CoV-2, the preliminary results show an efficacy rate of 89.3%. After review of the vaccine safety database it has also been reported that any adverse events were balanced between both the vaccine and the placebo groups and any serious or severe side effects occurred at low levels.
In the South African phase 2b clinical trial, an efficacy rate of 60% was seen in the HIV-negative cohort, with an overall 49.4% efficacy rate seen across the total 4,400 trial participants (both HIV-negative and HIV positive individuals). During the time of the trial, the South African variant of SARS-CoV-2 was widely circulating.
The Novavax COVID-19 vaccine candidate is a protein-based vaccine utilising a nanoparticle technology platform.
To read the full press release follow the link below:
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial