Flying is Less Safe Now Pilots are Covid Vaccinated

With apologies to the nervous flyer, I’m sorry to tell you that flying became less safe on December 8th 2020 when MHRA authorised Pfizer’s Covid vaccine in the U.K.  Let me explain.

Last month I wrote about Pfizer’s latest analysis of millions of patients’ data from a range of European national healthcare systems including the NHS. The data are segmented by categories like age, sex and, importantly, the Covid vaccination status of each patient (the very data which governments around the world continue to refuse to make public). Pfizer’s results include a ‘Hazard Ratio’ (HZ) which is a measure of the relative frequency of a serious adverse event between the Covid vaccinated and unvaccinated groups. As I said last month, Pfizer itself is now reporting to medicine regulators that its Covid vaccine has significantly increased the occurrence of a range of heart conditions. Here’s a screenshot :

What I didn’t say at the time is that I had also written to Sir Stephen Hillier, the Chairman of the Civil Aviation Authority, asking for his comments about the implications for aviation safety, and in particular the increased likelihood of a Covid vaccinated pilot being incapacitated in-flight by a cardiac issue. I didn’t mention that in my article because I had decided to give the CAA a chance to respond to my letter. However, a month on, it still hasn’t replied despite being chased – hence this further article.

“Not so fast,” you might say. “Even if Pfizer itself is now saying that its Covid vaccine increases the frequency of heart problems, the affected pilots will no longer be flying because they will have been screened out by the regular medicals which pilots have to pass to keep their licence.”  And it’s true, the number of U.K. pilots failing their aero medicals (all causes) has soared. Shout out to Sally Beck for reporting on that late last year:

Unfortunately, the CAA has just refused my FOI request for data on what proportion of those medical ‘fails’ were for heart conditions. It would only give me data for 2021 onwards – which of course prevents any pre/post-vaccine comparisons.

However, there is still a major problem. The periodic medical examinations required by aviation regulators don’t eliminate the risk of in-flight incapacitation. They never did. In fact, aviation regulators have, for years, scaled the periodicity and depth of those medicals against the frequency of sudden incapacitation in the general population. For dual pilot flights, aviation regulators use a ‘1% rule’: the probability of one of the pilots becoming incapacitated mid-flight must be less than 1% per year.  

The corresponding ‘rule’ for a solo pilot is an order less (0.1% per year) because there is no second pilot to take over. 

The problem should be obvious by now but I’m going to make it crystal clear. Pfizer’s latest report of increased heart problems in the Covid vaccinated has most likely invalidated CAA’s prior assumptions about the risk of incapacitation in the general population on which it based the periodicity and depth of its pilot medicals. So flying has become less safe since December 8th 2020 when MHRA authorised Pfizer’s Covid vaccine. 

Pfizer’s latest report obviously comes on top of the numerous media reports over the last four years of pilots becoming incapacitated mid-flight. That has always happened – aeromedicals just reduce the risk, they don’t eliminate it – and CAA collects information (called Mandatory Occurrence Reporting) on all such incidents. However, it is impossible currently to judge if there is any recent increase in heart-related pilot in-flight incapacitation because CAA states that “the release of occurrence information to the general public or the media, including in response to Freedom of Information Act (FOIA) requests, is not permitted”. 

Nevertheless, Pfizer’s latest reported figures are now there for all to see. Worryingly, CAA was unsighted until I alerted the CAA Chairman to Pfizer’s latest report in my letter of October 12th. How do I know? Because the MHRA admitted in a recent Parliamentary Written Question that it has not discussed Pfizer’s report with any industry safety regulators.

“Why not”, you ask. My guess is that MHRA didn’t make the connection. The problem is that medicine regulators’ idea of safety management is that a medicine is safe if ‘benefit outweighs risk’. That’s relative. If the risk increases it just carries on if its staff perceive (or can argue, however spuriously) that the benefit still outweighs it. That’s their whole mindset. I doubt they even saw the link to aviation safety because there’s probably no-one in MHRA with knowledge, experience or training about conventional safety management in other safety critical sectors, aviation or otherwise, all of which deal in absolute safety risks. Aviation regulators, rightly, don’t consider the ‘benefit’ of flying when assessing safety. It’s either safe or it’s not.

I think it’s also likely that CAA was reassured by MHRA’s ‘safe and effective’ narrative without realising that the medicine regulators define safety in such a relative way (‘benefit outweighs risk’). I wouldn’t be surprised if the CAA is now spitting feathers at MHRA for not having consulted it about Pfizer’s latest report.

To me, the solution is not just for MHRA and CAA to start that consultation. It is actually for medicine regulators to be stopped from maintaining the charade that safety should be defined as ‘benefit outweighs risk’. As I have suggested before, medicine regulators should be forced to adopt the same safety management principles as everyone else and have a minimum tolerable level of risk – how many people can be allowed to die or be seriously harmed before a drug is suspended. That level would be different for chemotherapy drugs compared with over-the-counter painkillers, but my point stands. I would hazard a guess that this would render a lot of drugs unsafe overnight. I wonder if Robert F. Kennedy Jr., whom Donald Trump has empowered to “Make America Healthy Again” by reforming the U.S. Federal Drug Administration (FDA) and the U.S. pharmaceutical industry, will address this obvious anomaly.

A few other things are worth pointing out:

• This is a ‘damage has been done’ issue. Heart damage is usually persistent. It’s irrelevant that airlines stopped mandating the Covid vaccine a few years ago, that a pilot might last have had the Covid vaccine several years ago, or even that it’s no longer being offered routinely to under 65s.
• One of CAA’s required medical tests is an electrocardiogram (ECG) which records the electrical signals in the heart which, in turn, can indicate a wide range of cardiac problems. If the routine ECG is abnormal, CAA specifies a range of follow-up tests. Perhaps Pfizer’s findings mean that aviation regulators like CAA should now require additional routine or follow-up heart-related tests, e.g. Troponin which is a biomarker for heart muscle damage and D-Dimer which detects blood clots.
• All of the above also applies to Air Traffic Controllers. They, too, are required by aviation regulators to pass periodic medicals.
• This is a global issue. Although Pfizer’s results are based on national healthcare data from just a handful of European countries (albeit covering tens of millions of patients), they are surely indicative of an increase in heart problems in Covid vaccinated pilots worldwide.

There is one final important point worth making. Pfizer’s report also has implications for other sectors where an individual is in control of a safety critical system with potentially catastrophic (i.e., fatal) impact on third parties. The obvious ones are drivers of buses, coaches, lorries and trains. They, too, are required by their respective safety regulator to pass a medical as a condition of a licence to operate. In those cases it’s the Driver and Vehicle Licensing Agency (DVLA) and the Office of Rail and Road (ORR) which, like the CAA, are accountable to the Department for Transport. Perhaps the House of Commons Transport Select Committee will investigate the safety impact of Covid vaccines on aviation and all the other sectors within its purview. Or the Covid Inquiry.

Or, as many think, are they all just in denial of the adverse safety profile of the Covid vaccines, or want to avoid the economic impact of loss of confidence in air travel and mRNA technology?

But at least none of them can deny having been warned – by Pfizer itself, no less.

Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.