he early months of 2021 have been in stark contrast to those same months in 2020 where much of Australia was ablaze from destructive, devastating, and unprecedented bush fires. Through the La Niña effect, our summer (when the country tends to “shut up shop”) has been wetter, cooler, and, at least on the eastern seaboard, there have been fewer fires. Sadly, Perth, Western Australia has recently lost many homes due to fire, reminding us of the escalating impacts of climate change.

However, COVID-19 continues to have a huge impact on our lives. Thankfully, we have escaped the catastrophe that has engulfed much of the globe, largely due to acceptance of evidence-based scientific advice regarding measures to prevent the spread of the infection by our governments and the overwhelming proportion of citizens. Although vaccinations are not due to commence until mid- to late February 2021, local transmission of infections has been virtually eliminated. Risk from citizens returning to Australia continues despite stringent quarantine and testing and tracing procedures.

One unanticipated “side-effect” of constraints on international travel has been a significant increase in value of house prices in the regions outside our large cities due to the seismic shift in working arrangements for many.

With respect to vaccination, it is heartening to learn that globally (as of early February 2021) as many people have been vaccinated against COVID-19 as have contracted the virus, although this impressively fast rate of vaccination has been largely driven by only ten countries. Unless global vaccination levels increase quickly, return to uncontrolled spread of variants of the virus is feared.

TGA has published excellent information regarding Australia’s COVID-19 vaccine approval processes, and plans for distribution available for consumers, health professionals, and industry. On January 25, our first vaccine (the Pfizer/BioNTech mRNA vaccine) was approved.

TGA is a supporter of the World Health Organisation (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) statement regarding the need for global regulatory alignment on COVID-19 medicines and vaccines. This alliance has committed to sensible and important steps to curb the global threat from COVID-19:

• “working to prioritise well-designed clinical trials that will provide robust and reliable results;
• ensuring that there are meaningful and scientifically sound endpoints and safety data of sufficient duration in clinical trials;
• sharing data between regulators in real time to facilitate multi-country approvals;
• putting in place processes and policies utilising the principles of regulatory agility by ICMRA members and WHO member states, providing an agile and rapid response to the global emergency;
• committing to full transparency of clinical trial results to support regulatory decisions, as well as ensuring public trust in authorities and confidence in vaccines;
• working together to prevent and/or mitigate shortages of critical medicines and vaccines;
• continue working together once these COVID-19 therapies and vaccines are authorised and used to monitor their use, and identify, communicate, and mitigate any safety or efficacy issues which may arise; and
• reduce the risks associated with unproven treatments, potentially fraudulent and false claims, which endanger patients’ lives.”

Reassuringly, TGA is meeting weekly with 30 international medicines regulators via ICMRA. The goal: to improve communication, share information, respond to crises in a coordinated way, and, importantly, address matters of regulatory science pertinent to potential COVID-19 vaccines, including trial design and data requirements.

Regarding access to vaccines and treatments, Australia is part of the Access Consortium which has been recently boosted by the addition of the United Kingdom (UK) regulatory agency (MHRA) to the regulatory agencies of Canada, Singapore, Switzerland, and Australia. The Consortium is responsible for regulating medicines for their 145 million citizens. Again, the laudable goal is timely access to high quality, safe, and effective therapeutic products for consumers, promoted via international cooperation. Sharing improved practices and reducing duplication of work is expected to raise the standards, efficiency, and capacities to deal with increasing workloads and demands on regulators. An anticipated bonus is simultaneous and shorter evaluations for pharmaceutical company sponsors submitting applications to one or more Access Consortium countries.

In another COVID-related development, TGA has opened an important new consultation examining potential “obstacles and incentives” to sponsor’s decisions to “repurpose” prescription medicines, typically to extend registration for often widely accepted evidence-based indications incorporated in Australian Therapeutic Guidelines. The window for submissions is February 4 to March 23, 2021. The consultation not only seeks responses concerning registration but also, critically, reimbursement that could inform new policy options. The rationale is well summarized in the “call for responses.” The hunt for registered medicines potentially useful to treat COVID-19 (for example, hydroxychloroquine) has stimulated this overdue initiative. Despite efforts of TGA working with specialist medical groups to promote new applications from sponsors over the years, these have often (but not always) been unsuccessful. Sponsors cite a variety of reasons; for example, being “off-patent” for innovator sponsors, and the “expense involved” for generic sponsors. Patients are disadvantaged at several levels. For instance, without TGA registration, listing on the Pharmaceutical Benefits Scheme is very difficult, which means the drug will not be prescribed as often as the evidence recommends.