COVID-19 Vaccination Information Distillation 2: New vaccines, regulation and a Commonwealth indemnity scheme

Australia's vaccination program for COVID-19 has gained new momentum from the Delta variant outbreak. As at the date of writing, almost 35% of the eligible (over 16 years old) Australian population has received two doses of a COVID-19 vaccination.

In July the Therapeutic Goods Administration (TGA) provisionally approved the Pfizer COVID-19 vaccine for individuals aged 12-15 years and over. In addition, two vaccines received provisional approval for use in adults in June and August respectively, with one of those also under evaluation for use in 12-17 year olds. Further, the TGA has introduced new regulatory arrangements to permit certain representations to be made by healthcare professionals, employers and others to support the national COVID-19 vaccination program.

The Commonwealth Minister for Health, the Hon. Greg Hunt MP, has also just announced that the "COVID-19 Vaccines Claim Scheme" will begin taking registrations from individuals who claim they have suffered a proven adverse reaction to a COVID-19 vaccination from 6 September 2021.

Provisional Approval

The TGA has granted provisional approval to Janssen-Cilag's viral vector COVID-19 vaccine and Moderna Australia's Elasomeran mRNA vaccine for use in persons aged 18 years and over.

The Janssen and Moderna vaccines join the Pfizer and AstraZeneca vaccines as the third and fourth COVID-19 vaccine to be provisionally approved by the TGA.

Provisional approval means these vaccines have been permitted by the TGA to be administered to the Australian public. Before the vaccine can be administered the Australian Government will need to secure supply of the vaccines. The Australian Government has secured 10 million doses of the Moderna vaccine for supply in late 2021 and 15 million doses of an updated Moderna vaccine to be used as a booster in 2022. There is currently no supply agreement in relation to the Janssen vaccine.

The Janssen vaccine's Australian public assessment report (AusPAR) is available here on the TGA's website, while the Moderna vaccine's AusPAR is here.

Further vaccines under TGA consideration

The following COVID-19 vaccine remains under evaluation:

This vaccine has provisional determination but has not yet been approved by the TGA to be administered to the Australian public. The TGA will continue screening this vaccine for safety, quality and effectiveness before it is approved.

Moderna's Elasomeran is also currently under evaluation for individuals aged 12-17 years.

Continued monitoring

The TGA has continued to publish weekly safety reports on the COVID-19 vaccines; see the latest report here. Over the course of the COVID-19 vaccination program, the TGA has received over 52,000 reports of suspected adverse events in relation to the vaccines, to be considered against the more than 17 million doses administered. This represents a reporting rate of 3.1 adverse event reports per 1,000 doses of the vaccines.

2021 Permission: Regulatory arrangements to support promotion of COVID-19 vaccines

Since early 2021 there has been active public debate in Australia about vaccination generally, and the relative merits of the two COVID-19 vaccines currently available in Australia. This type of public debate is highly unusual in circumstances where direct-to-consumer advertising of prescription medicines and vaccines is prohibited in Australia, and there are important restrictions on advertising which mention "serious forms" of disease (the kinds of conditions or diseases that require diagnosis or treatment by a healthcare professional), or which relate to vaccines that are part of a Commonwealth or State/ Territory campaign.

In the therapeutic goods context, "advertise" is broadly defined, and includes any statement, picture or design intended to promote the use or supply of therapeutic goods. While educational or informational content is not an "advertisement", the line can become blurred where individuals or entities are seeking to encourage COVID-19 vaccination. Care must be taken.

The TGA has had to adapt the usual regime to the current environment and now permits the use of certain representations in advertisements about COVID-19 vaccines, where those comply with the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission (No. 3) 2021 (Cth). The Permission covers two key aspects: content encouraging the use or supply of COVID-19 vaccines and offering rewards for vaccination. The TGA has also published guidance about how the Permission (which will expire on 31 December 2022) applies to different types of communications regarding COVID-19 vaccines.

Employers who are considering providing information to their workers about the COVID-19 vaccines, or encouraging (or mandating) COVID-19 vaccination, should also give careful consideration to the communications they are publishing, to ensure compliance with the Permission.

Commonwealth's COVID-19 Vaccine Claim Scheme

The Government has made a further announcement about its COVID-19 Vaccines Claim Scheme, which will be open for registrations from 6 September 2021. Details about how the program will be rolled out, how (if at all) it may interact with other patient rights, and who may make a claim, are still absent from the announcement. Having regard to the July and August press releases, it appears that:

• the Scheme will provide an administrative process whereby individuals who may have claims >$5,000 can apply for compensation from the Government;
• the Scheme will cover the costs of injuries above $5,000 due to a proven adverse reaction to a COVID-19 vaccination;
• compensation payments will be awarded in accordance with assessment by independent experts; and
• the Scheme will provide a shorter administrative alternative to Court processes, but will not necessarily replace or remove a person's right to access usual Court processes.

Related Insights

• COVID-19 Vaccination Information Distillation: TGA's registration process for the COVID-19 vaccine and what to consider now