Australia’s Therapeutic Goods Administration (TGA) announced Monday that it has granted approval for full registration of Moderna’s Covid vaccine, Spikevax. This is the first Covid vaccine in Australia to receive full registration – the others remain provisionally approved.
From the TGA media release:
As with all medicines, the TGA’s assessment was rigorous, independent and based on evidence. The safety and efficacy of Spikevax is also supported by real-world use in millions of people worldwide, providing reassurance about the safety of these vaccines. Vaccination remains the most effective way to protect yourself from serious disease, hospitalisation and death.
This is the product that currently has 7,442 reported adverse events in DAEN (Australia’s VAERS or Yellow Card database). Thirty-six of these entries are reported deaths.
This is also the product that, on independent reanalysis of its own trial data, was revealed to have a serious adverse event rate of 15 per 10,000 doses.
The same one that has been phased out of use in the U.S.
By the time Moderna stopped collecting safety data from the P201 trial in mid-2021, 14 out of 550 people (2.5%) who received jabs in the trial had suffered serious side effects…
These trialists were a generally healthy group – healthier than the Phase 3 trialists, or average Americans. For example, Moderna excluded people with diabetes from P201, and few people in the trial were obese.
Aside from miscarriages, the other serious side effects are mainly cardiovascular, with six total. Despite the relative health of the participants, they include heart rhythm disorders, the heart attack, pericarditis, and a pulmonary embolism.
Achieving full registration status for its first ever commercial product bodes well for Moderna. In 2022, the pharmaceutical company finalised a partnership with the Australian (federal) and Victorian (state) Governments to establish an mRNA vaccine production facility in Melbourne.
In the future, Australians can expect mRNA vaccines to be available for all manner of ills. From Moderna’s announcement of the Australia-Victoria partnership:
Moderna’s mRNA pipeline includes 28 vaccine candidates, including vaccines against respiratory viruses, vaccines against latent viruses and vaccines against threats to global public health.
Once operational, the Melbourne facility will be able to produce up to 100 million vaccine doses every year. That’s enough for roughly four doses of vaccine per Australian annually.
The Queensland Government is also in on the mRNA action. In December 2022, Premier Annastacia Palaszczuk announced a partnership with vaccine makers Sanofi to establish a ‘global vaccine hub’ in Brisbane. In 2021, Sanofi announced its manufacturing partnership with Moderna to produce Covid vaccines.
According to the Queensland Government, the biomedical industry contributes around A$2.1 billion (£1.1bn) in gross value-added product and employs more than 12,000 people across the state.
With a Covid vaccine injury class action heading to the courts in Australia, and a ‘tsunami’ of vaccine injury media coverage in Germany highlighting the downside of the current mRNA vaccines, it’s hard to see the public maintaining enthusiasm for such allocation of their tax dollars into the medium term.