The danger of incompetence

So, Dr Anthony Fauci has apologised for incorrectly stating that the British approval of the Pfizer/BioNTech had been rushed. It has been seized upon by those wishing to prove there is something unsafe about the vaccine and its approval. So, let's take a look behind the claims to see how much validity they had.

Some might find it useful to read my previous blog on a related subject about the myths surrounding the vaccine here.

The US is expected to give approval for the Pfizer vaccine early next week and the EU the week after.

In the world of statistics, a data expert would call the difference in timing between the British approval and that of the US and EU as being 'statistically insignificant' - meaning that the time frames for development of the vaccine were essentially identical.

The British process actually took longer

The British approval authority, The Medicines and Healthcare Products Regulatory Agency (MHRA) started work on auditing the candidates as soon as any organisation developing a vaccine had reached a point where they believed they had a viable solution. So, the MHRA started working with Pfizer (and the other organisations who are developing a vaccine) back in early summer. Because they were auditing the process from that early stage, they were able to rule out any project which did not meet their exacting standards thus saving valuable wasted money, time and effort. The American Food and Drug Administration started work once a drug company filed for a permit so the American Food and Drugs Administration (FDA) didn't start serious work until 4-5 weeks after the MHRA.

So - the reality is that, far from being rushed or premature, the British process has actually taken marginally longer than the US process.

Is the process any different?

In the US, they spend more time pouring over base data. Given that most of the data about coronavirus and the development of the vaccine for C-19 has been developed since the 1960s (when the first strain of coronavirus was identified), that is basically an exercise in re-auditing something that had already been audited. As the BBC reports, that has led to suggestions that the US has got bogged down in a detailed review that wasn't necessary and added almost no value.

The MHRA (and indeed the European Medicines Agency based in The Netherlands) concentrates more on the efficacy and the effectiveness of the drug, paying greater attention to the safety of the proposed vaccine and the outcomes of clinical trials because the science has already been validated.

But basically, both the UK and the US, and indeed just about every reputable authorising body in the world, all follow a pretty similar process to largely identical standards. This is not surprising really. The development of safe drugs is one of the most regulated industries on earth so it makes sense that countries share knowledge and expertise. Having a similar process that everyone follows makes that easier for all.

The standards required to gain approval are startlingly similar. So, if the US and EU approve approve the vaccine in the next couple of weeks, they have basically reached precisely the same conclusion that MHRA did this week in the UK. They are all declaring it safe based on identical standards using the same process, so all we're actually debating here is the fact that one country got there a few days earlier than another

So, building on our first point, the UK has taken a slightly longer time than the US to complete basically the same process to the same standards and the same level of scrutiny. And, unsurprisingly, reached the same conclusion.

Is political influence to blame?

The FDA is part of the federal government and reports through a political chain of command. It is far more subject to political influence than its British or European counterparts. Politics may explain why the FDA hasn't yet given the green light. Back in October, President Trump pressured health officials to approve the first vaccine candidates before election day on 3 November but they pushed back, fearing it might become a political football. However, in attempting to assert their political neutrality, they are also confirming that they were in a position to have given approval for the vaccine at that point - which would have been a full four weeks before the British approval was granted.

The MHRA is entirely independent and reports through a professional chain of command (ie - it reports through experts in the relevant fields - it does not report through politicians). Its officials and leadership are all politically neutral. According to 'Le Figaro' (French newspaper) this week, "there is...general agreement that MHRA is globally recognised for its diligence, expertise and excellence and [is the] de facto benchmark for drugs administration standards around the world".

Is there any evidence to suggest approval was rushed through?

No. None. There are plenty of 'Sandra from Facebook' posters who suggest the vaccine has been rushed, that we don't know of any long term damage it may cause or a myriad of other claims (this is definitely worth a read for those whose keep an open mind) but its all opinions, no facts or data.

The reality is that there is not one single piece of empirical evidence to demonstrate that the vaccine is unsafe in any way whatsoever or that approval was compromised in the interests of getting it created as quickly as possible.

Was the entire process speeded up by having more resource thrown at it? Absolutely - by every country in the world (which of course is why they managed to get through so much backbreaking work in such a relatively short amount of time).

Were any steps skipped? Were any protocols or standards lessened? Was any safety aspect reduced, ignored or simply ignored? Was anything done which might compromise the safety and effectiveness of the vaccine?

No.

Was the vaccine subject to the same level scrutiny as any other new drug? Did it follow the same process for approval as any other vaccine being brought to the market? Has it been subjected to the most rigorous and intense process?

Yes.

So basically what 'Sandra from Facebook' is saying is that her warning about the safety about this drug mean that she knows better than all these global experts around the world, with their plethora of degrees and decades of experience in immunology, epidemiology, virology and related medical science, and to me, that doesn't make sense.

Summary and Thank You

So - given that we know that the process has taken much the same amount of time (slightly longer in the UK because of the earlier start), and has followed the same process to the same standards and - as the next couple of weeks will demonstrate - reached the same conclusion, one must therefore assume that Dr Fauci's concerns are based on the fact that the UK made its declaration a matter of days before the US makes theirs. Is it really credible to suggest that in those extra few days, the US will have done so much more exhaustive research, analysis and scrutiny?

It seems far likely that they've all done exactly the same work and reached the same conclusion in basically the same time period - and they should all be proud of their own, and each others', efforts.

One is left with the lingering feeling that perhaps Dr Fauci's comments were more a product of wounded professional or national pride.

Again, I do not write this to support or undermine any particular point of view or opinion. I am merely trying to bring some clarity and facts to a clouded environment. I may have succeeded and I may have failed - but at least the intention was sincere.

I want to finish by paying tribute to all those thousands of women and men around the world whose efforts have brought these vaccines to fruition: Everyone involved in the millions of hours of research testing, clinical trials, research, validation and finally authorisation of these vaccines. These ordinary men and women who have done so much and given so much deserve our gratitude, for their back-breaking efforts.

To every single one of you - thank you from the bottom of all our hearts. You have saved millions of lives.

Stay strong. Fight hard. Laugh lots.