ATAGI advice gives governments a chance to 'walk back' their missteps on AZ

On 23 July 2020, exactly one year ago, BioPharmaDispatch asked where is Australia's COVID-19 vaccine strategy? Wind the clock forward to today with a stalling vaccine rollout and it is hard not to conclude that even if there was a strategy it was significantly flawed.

The vision of the prime minister attempting to so publicly coerce the federal government's chief technical advisory committee on vaccines was ill-considered and completely unnecessary given the wording and obvious intent of its advice. 

The Pfizer-BioNTech and AstraZeneca-Oxford vaccines are close to as effective against the 'delta' variant of COVID-19 as they are against the 'alpha' variant, according to a study published in The New England Journal of Medicine.

Australian mid-clinical stage antiviral drug development company Island Pharmaceuticals has announced two agreements for the manufacturing of its lead asset.

A new report commissioned by Novartis says change is required to ensure Australian patients are able to access the more than 2,000 cell and gene therapies currently in development with the US FDA expecting to evaluate 10 to 20 each year by 2025.

The Novartis boss said, "In the end, we need something that is sustainable and that means challenging how much longer it is taking. We just want to bring these therapies to patients in Australia faster."

The prime minister has urged the Australian Technical Advisory Group on Immunisation to reconsider its advice limiting the use of AstraZeneca's COVID-19 vaccine.

AstraZeneca has completed its US$39 billion takeover of Alexion with the company welcoming its acquisition of a portfolio of medicines for rare diseases.

The supply issues impacting the COVID-19 national immunisation program have become even more evident with an updated analysis at day 150 showing it continues to stagnate and fall behind those in comparable countries with Malaysia the latest to catch up with and pass Australia.

Companies might now be paying over half a million dollars to navigate the PBS listing process but the service levels have not improved judging by the correspondence seen by BioPharmaDispatch.

The situation for New Zealand patients dealing with an outbreak of a serious lung virus has now been made worse by a shortage of a commonly prescribed medicine.

MSD has welcomed an expanded PBS listing for cancer immunotherapy KEYTRUDA (pembrolizumab) to include around 300 people diagnosed with a form of advanced bowel cancer.

The authorisations mean a pharmacy could negotiate an arrangement with a local pub to reward the fully vaccinated with beer or other alcohol, promote that arrangement, while also advertising the availability of nicotine e-cigarettes.

"They're literally happy for you to just die and hope that the families will just fade away," said the mother of a patient whose family relocated to Australia to gain access to a therapy.

Medicines Australia has welcomed the federal government's consultation on the creation of a ‘one-stop-shop’ for clinical trials.

The McKell Institute says accelerating the involvement of community pharmacies in the roll-out of COVID-19 vaccines could help Australia reach its immunisation target two months earlier than current projections with the potential to avoid $12.3 billion in economic costs.

Possibly the most revealing part of the more than 50 page Public Summary Document for the PBAC's March deferral of Vertex's TRIKAFTA for cystic fibrosis is the last paragraph on the final page.

Senior Department of Health officials publicly acknowledged these products are already freely available and that they are not safe, that they do not work as a tool to support smoking cessation and act as a 'gateway' to tobacco smoking, while a Senator has said the parliament has been "constantly bombarded by lobbyists" claiming the opposite.

If the federal government through the Department of Health is setting 'parameters' for PBAC decision-making then any credible claim to transparency requires that they be disclosed - if there are rules, the community has a right to know.

The current year has bizarrely seen Australia's TGA effectively endorse the consumption of alcohol and nicotine e-cigarettes as devices to support public health.