Chris

AstraZeneca lacks experience in vaccine development, which is probably what's behind the inconsistencies in their phase 3 trials, which in turn led to a poorer data set that some regulators wanted to take longer to read over. Had we not been in a pandemic, and had they had the luxury of time, these shortcomings would most likely have been spotted and corrected long before any data was sent for approval.

Again, had we not been in a pandemic, the precautionary principle would absolutely favour the cautious approach shown by some national regulators. However, there is a very strong argument for saying these regulators have failed to adjust their decision-making processes to allow for the fact that we are in a pandemic in which significant numbers of people are getting very sick and dying. Even in the face of weaker efficacy data there was ample phase 2 data that amounted to indirect evidence of efficacy - the UK regulator's approach was that in these circumstances, the indirect evidence was sufficient.

The broo-ha-ha in many European countries now appears to be an unholy combination of inadequate decision making processes (still sticking doggedly to the precautionary principle, despite evidence that slowing the vaccination programme will kill more people) and regulatory over-caution thanks to the calculated political vandalism perpetrated by a few very well-placed politicians like Emmanuel Macron, a few weeks ago when the UK's successful programme needed taking down a peg or two because it was showing up the EU. As Damien observed earlier, once you let the anti-vax genie out of the bottle it is very difficult to get it back in, and I think some politicians and regulators are now over-thinking every step as they try to persuade their populations that getting vaccinated is safer than not doing so.