TGA grants additional provisional determination for a COVID-19 vaccine
The Therapeutic Goods Administration (TGA) has granted provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) for their COVID-19 vaccine candidate.
Granting provisional determination means that Biocelect (on behalf of Novavax) is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.
You can read the press release from the TGA below:
TGA grants additional provisional determination for a COVID-19 vaccine
For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia
The Times of Israel: Israel expands vaccination campaign to teens aged 16-18
Israel have expanded their COVID-19 vaccination program to include teenagers aged ≥ 16 years, with the first vaccines being given in this age group on January 23.
Initial immunisation in Israel began in December 2020, prioritising health care workers, the elderly and other at-risk groups. To date, 2.5 million people have received a dose of the Pfizer BioNTech COVID-19 vaccine, with 900 thousand of those, also having received their second dose.
To read more, follow the link below:
The Times of Israel: Israel expands vaccination campaign to teens ages 16-18
COVAX announces new agreement, plans for first deliveries
The COVAX Facility has announced the signing of an advance purchase agreement for up to 40 million doses of the Pfizer/BioNTech COVID-19 vaccine.
COVAX is on track to deliver at least 2 billion doses of COVID-19 vaccines by the end of the 2021, including at least 1.3 billion doses to 92 lower income countries.
For more information please follow the link below:
Gavi: COVAX announces new agreement, plans for first deliveries
ATAGI advice on influenza and COVID-19 vaccines
The Australian Technical Advisory Group on Immunisation (ATAGI) have published advice related to the administration of influenza and COVID-19 vaccines.
Due to a lack of safety and immunogenicity data on the co-administration of these vaccines, it is therefore recommended that influenza and COVID-19 vaccines are not administered on the same day, but with a minimum interval of 14 days. There is no preference regarding the order of vaccine administration, noting that both the Oxford/AstraZeneca and Pfizer/BioNTech COVID-19 vaccines require a 2-dose schedule. If influenza and COVID-19 vaccines are inadvertently administered on the same day or are administered within a shorter timeframe than 14 days, revaccination with either vaccine is not recommended.
To read the advice in full, refer to the link below:
ATAGI advice on influenza and COVID-19 vaccines
Mobilising Australia’s COVID-19 vaccine workforce
The Australian Government have confirmed that COVID-19 vaccine delivery will be carried out by hospitals, general practices, state and commonwealth vaccination clinics, Aboriginal Community Controlled Health Organisations and Pharmacies.
To supplement our already established vaccine workforce, and assist in vaccine delivery to outreach locations, Aspen Medical, Healthcare Australia, International SOS, and Sonic Clinical Services have been contracted to support each jurisdiction in their vaccine program.
To read the announcement in full, follow the below link:
Mobilising Australia’s COVID-19 vaccine workforce
GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID-19 vaccine, BNT162b2
The role of the Global Advisory Committee on Vaccine Safety (GACVS) is to provide independent, expert advice to the World Health Organization on the safety of vaccines.
On January 19 2021 a virtual meeting was held to review all available information on the deaths reported in frail, elderly individuals who had received the Pfizer/BioNTech COVID-19 vaccine. Following this review, it was concluded that vaccination has not contributed to any unexpected or increase in number of fatalities in this patient group. As such, there is no change in recommendations around safety of the Pfizer/BioNTech COVID-19 vaccine.
To read more, follow the link below:
COVID-19 vaccine rollout: Primary care participation in Phase 1b–call for expressions of interest from General Practices
In preparation for the rollout of COVID-19 vaccines in Australia, accredited general practices are invited to express their interest in participating in Phase 1b of the COVID-19 Vaccination Program.
Phase 1b of the COVID-19 Vaccination Program is dedicated to delivering 14.8 million doses of the University of Oxford/AstraZeneca COVID-19 vaccine (dependant on TGA approval).
The Phase 1b priority populations include:
- People aged 70 years and over
- Aboriginal and Torres Strait Islander adults
- Critical and high-risk workers including defence, police, fire, emergency services and meat
processing
- Health care workers other than those prioritised in Phase 1a, including (but not limited to)
hospitals, general practices, pharmacists, allied health, and other healthcare services in the
community
- People at increased risk of severe disease
For further information, including how to register your interest, please follow the link below:
Complete program for the CVU Miniseries virtual event now available
The next Clinical Vaccinology Update Miniseries event, COVID-19 vaccines: a Victorian landscape, will be held virtually on February 8th, 2021.
We are excited to welcome our presenters who will be covering the COVID-19 vaccine landscape in Victoria, including vaccine safety, Victorian COVID-19 vaccine rollout plans and stakeholder engagement and participation.
This is a free event, however you will need to register for tickets via the link below, where you can also view the complete program:
CVU Miniseries: February 8, 2021
New immunisation reference page: COVAX Facility
The COVAX Facility is coordinated by Gavi (the Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization. It brings together governments of over 180 countries, global health organisations, private sector, scientists and manufacturers, in order to provide innovative and equitable access to COVID-19 diagnostics, treatments and vaccines. Our new reference page details information on the COVAX Facility COVID-19 vaccine portfolio.
To read more please refer to the link below:
New immunisation reference pages: COVID-19 vaccines
In 2020, the Australian Government entered into four Advance Purchase Agreements (APA) for the supply of COVID-19 vaccines, if they prove safe and effective. More than $3.3 billion has been invested through these agreements, putting Australia in a strong position to access safe and effective vaccines when they become available. In 2021, three of these vaccines are still active, with the 4th (University of Queensland) withdrawn from clinical trials. Our new reference pages detail information regarding the clinical trials of each vaccine candidate, interim data on their safety and efficacy, as well as other vaccine specific information.
To read more please refer to the links below:
- MVEC: University of Oxford/AstraZeneca COVID-19 vaccine
- MVEC: Pfizer/BioNTech COVID-19 vaccine
- MVEC: Novavax COVID-19 vaccine