Monday, December 14, 2020

Hurry Up And Then Stop

Australia is not following the science.  The decision to dither on the Covid-19 vaccines will not delay the economic recovery but could risk lives and undermine faith in immunisation.

Last week the United Kingdom became the first country on the planet to approve the BioNTech-Pfizer vaccine.  This week rollout began.  The United States is expected to do the same in the coming days.

This is a momentous occasion for humanity ― from new disease to safe and effective vaccine in less than a year.  Millions of lives will be saved.

The Australian government has responded by painting our friends in Old Blighty as reckless.  Australia's Therapeutic Goods Agency (TGA) will wait until at least late January, if not February, for approval.

Distribution will begin in March.  "Well, I wouldn't want to use the word guinea pigs with the UK," John Skerritt, the head of the TGA said last week.

Skerritt did, nevertheless, talk up waiting for "the real world experience of several hundred thousand people having had the vaccine".

Australia's vaccine urgency is obviously not the same as elsewhere.  The border-first strategy and effective testing and tracing has kept cases extremely low.

Nevertheless, a slow vaccination rollout has real consequences.

On the health front, the government announced in September that Australia would have early access to 3.8 million doses of the University of Oxford/AstraZeneca vaccine available in January and February.

This would have allowed for the potentially life-saving immunisation of aged care residents and healthcare workers before the risk of spread grows again in winter.  These doses now appear to have fallen out of the equation.

On the economic front, Australia is a small, outward-looking trading nation that depends on people.  University and tourism sectors are already on their knees.

Australia's unemployment rate is now higher than many countries hit harder by the virus, including the US and the UK.  Meanwhile, as relations with China sour, building new links is paramount — and it takes face-to-face meetings to build trust for those multi-billion dollar deals.

The sooner we begin vaccinating, the sooner the risk to human life decreases, borders can reopen and the economy can fully recover.  Manufacturing, distributing and vaccinating millions of people, across two appointments, will take many, many months.  The quicker Australia begins this process the faster it will be over.

Trust must also be built.  The government has rightly said the vaccine will be voluntary.  People will therefore have to be persuaded it is safe and effective.

The insinuation that the UK has rushed approval risks sowing the seeds of doubt.  But Britain's regulators have not cut corners.

Their speed is explained by undertaking the usual rigorous steps in parallel, as new information was received, rather than at the end.

The vaccine itself was developed so quickly because scientists adapted existing technologies, designed to tackle other diseases, including coronaviruses like SARS and MERS.

Sarah Gilbert from Oxford has explained that "it's not breakthroughs.  We know what to do and we do it, and everything has worked out as expected."

There was also a singular global focus on developing a vaccine and big investments in trials, manufacturing, and distribution.  Never in human history have so many scientists, companies and governments been so focused on a single goal.

Also, the pharmaceutical multinationals, many of which are household names, have an extraordinary incentive to provide a safe vaccine.

The vaccines did not cause any serious side effects in tens of thousands of people after many months.  This is very reassuring.  Side effects typically appear straight away.

We won't know anything about longer term effects before Australian regulators look next month.  If we are waiting for that unknowable and unlikely long term side effect to suddenly materialise the vaccine will never be approved.

The clearest excuse for Australia's tardiness is the lack of emergency approval mechanism like the US and the UK.  This is worrying.

If Australia did have a large outbreak there would be no legal way to immediately start providing vaccination.  The same applies to other breakthrough medicines.

The Covid-19 vaccines represent a revolutionary shift in medicine.  The mRNA technology behind the BioNTech/Pfizer and Moderna vaccines can also be used to beat cancer, influenza, malaria, HIV, and much more.  There are also many other medical innovations on the horizon.

If Australians are to benefit sooner rather than later, it will take a new patient-centric approach to medicines regulation.

Australia should recognise approvals by the European Union, United Kingdom and United States.  Their regulators are robust and are stuffed full of the top global experts.

Australia's forthcoming trade deal with the United Kingdom should also use the idea of mutual recognition of product standards to facilitate much easier trade.

Australia also needs Right to Try legislation:  those with terminal diseases should be free to use any experimental drug from anywhere in the world.  There will be immense risks, but between death and potential survival the choice is obvious.

Approval delays are a deadly business.  Australia can do better.

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