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


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


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:

COVID-19 vaccine rollout: Primary care participation in Phase 1b–call for expressions of interest from General Practices