Thread by @DaveKeating

A thread on conditional authorisation (used by EU) versus emergency use authorisation (used by UK & US) for vaccines - a topic that I think is going to be more explored in the coming days given the AstraZeneca news out of Germany today.

First off: what's the difference?

Each type of vaccine approval comes with pros and cons:

🐇Emergency is faster but it's risky - requires less data and makes govs liable instead of pharma if anything goes wrong.

🐢Conditional takes longer but is more robust and makes pharma accountable.
thebulletin.org/2020/11/is-eme…

The 27 national authorities decided EMA should use conditional approval back in October, at a time when the extent of the 2nd wave & new strains wasn't yet known.

The UK & US chose emergency approval - controversial in US at the time because it looked like Trump was rushing it.

As 2nd wave hit in Nov/Dec, several EU countries started getting nervous.

But notably, all of them had the ability to give emergency use authorisation before the EMA's conditional approval. None of them chose this.

The UK, which was still under EU rules, did choose this route.

The assumption at the time was the few extra weeks required for conditional approval wouldn't make a big difference in a one-year vaccination campaign.

And, crucially, the EU believed its contracts meant pharma companies couldn't give away their promised doses in the mean time.

But MEP Peter Liese said this morning that while BioNTech/Pfizer honoured this commitment to be ready to go as soon as EMA approved, it appears #AstraZeneca hasn't.

Seems AZ gave away doses promised to the EU to those who used earlier emergency approval.

https://twitter.com/DaveKeating/status/1354771803747594240?s=20

This may change thinking on approval methods.

If the assumption that pharma companies would still be ready with the promised doses even if a longer more-robust approval method was used has been proven wrong, is it time for EU, or EU countries, to switch to emergency approval?

For his part, Liese says he still believes emergency use authorisation is not a good idea.

New revelations today about AZ data for over-65s may reinforce that.

https://twitter.com/DaveKeating/status/1354771801629483008?s=20

But the AZ delivery scandal and the prospect of a #VaccineWar with UK will tempt some EU countries to emergency-approve like Hungary has with #SputnikV.

If they can't trust companies to honour their delivery schedules, speed may now trump safety concerns.

https://twitter.com/DaveKeating/status/1354771797967831041?s=20

This is what can happen when you portray vaccine approval by independent regulators as part of the vaccine rollout "race".

A race to the bottom where speed trumps certainty, where decisions are rushed to make sure the company you've contracted with doesn't give away your doses.