I have been highly critical of the FDA but in Australia the FDA is almost a model to be emulated. Steven Hamilton and Richard Holden do not mince words:
At the end of 2020, as vaccines were rolling out en masse in the Northern Hemisphere, the TGA [Therapeutic Goods Administration, AT] flatly refused to issue the emergency authorisations other regulators did. As a result, the TGA didn’t approve the Pfizer vaccine until January 25, more than six weeks after the US Food and Drug Administration (FDA), itself not exactly the poster child of expeditiousness.
Similarly, the TGA didn’t approve the AstraZeneca vaccine until February 16, almost seven weeks after the UK.
In case you’re wondering “what difference does six weeks make?“, think again. Were our rollout six weeks faster, the current Sydney outbreak would likely never have exploded, saving many lives and livelihoods. In the face of an exponentially spreading virus that has become twice as infectious, six weeks is an eternity. And, indeed, nothing has changed. The TGA approved the Moderna vaccine this week, eight months after the FDA.
It approved looser cold storage requirements for the Pfizer vaccine, which would allow the vaccine to be more widely distributed and reduce wastage, on April 8, six weeks after the FDA. And it approved the Pfizer vaccine for use by 12 to 15-year-olds on July 23, more than 10 weeks after the FDA.
And then there’s the TGA’s staggering decision not to approve in-home rapid tests over reliability concerns despite their widespread approval and use overseas.
Where’s the approval of the mix-and-match vaccine regimen, used to great effect in Canada, where AstraZeneca is combined with Pfizer to expand supply and increase efficacy? Where’s the guidance for those who’ve received two doses of AstraZeneca that they’ll be able to receive a Pfizer booster later?
In the aftermath of the pandemic, when almost all of us should be fully vaccinated,there will be ample opportunity to figure out exactly who is to blame for what.
But the slow, insular, and excessively cautious advice of our medical regulatory complex, which comprehensively failed to grasp the massive consequences of delay and inaction, must be right at the top of that list.
You might be tempted to argued that the TGA can afford to take its time since COVID hasn’t been as bad in Australia as in the United States but that would be to ignore the costs of the Australian lockdown.
Article 13 of the Universal Declaration of Human Rights states that
- Everyone has the right to freedom of movement and residence within the borders of each state.
- Everyone has the right to leave any country, including his own, and to return to his country.
Australia has now violated each and every clause of this universal human right and seemingly without much debate or objection. It is deeply troubling to see people prevented from leaving or entering their own country and soldiers in the street making sure people do not travel beyond a perimeter surrounding their homes. The costs of lockdown are very high and thus so is any delay in ending these unprecedented infringements on liberty.