I HAVE just logged on to enter a patient with a fatal flare-up of malignant melanoma (originally diagnosed and surgically excised in 2014) manifesting as a suspected stroke with unilateral arm paralysis at the end of February, exactly one month after the patient’s first dose of the AstraZeneca coronavirus jab. This is the sixth Yellow Card report I have made in a month.
It seems entirely plausible to me, from a biological perspective, that natural tumour-suppressing activity of our lymphatic cells (NK cells and various classes of T Cell) could be temporarily suppressed by the surge of spike protein induced by the vaccine. As this is a new class of drug, which was rushed to market at breakneck speed, it is my clinical instinct that we should err on the side of over-caution as regards reporting observational anomalies or potential adverse reactions. With this week’s news that Denmark and other countries have suspended the use of the AstraZeneca vaccine, this approach seems even more sensible.
As a doctor with more than three decades of experience, this observational practice defines a long tradition of proper science.
But just how accurate and usable is the adverse event Yellow Card reporting system in the UK? Given the highly experimental nature of the Covid-19 vaccine, was due diligence given to making sure those rolling it out, and indeed those receiving it, were well versed in this system of reporting?
I have noticed that young doctors I work with are rather perversely trained not to respond to their instincts and clinical observations. The strict and immovable hierarchy within the NHS quickly instructs them that in this environment, the squeaky wheel definitely does not get the grease. It may find itself rolled out of the door, never to return. Working in a sector with only one potential employer, viz the NHS, this is not a risk many young medics would be prepared to take.
Using the MHRA (Medicines and Healthcare products Regulatory Agency) reporting system for adverse effects following the vaccine is a shockingly unlikely thing to happen among hospital doctors where I work. From many discussions I have had over the years, I know that this is also the case in various hospitals where colleagues work. None have had any training in using the online system and many seem surprised to learn of its existence.
The net result is that many adverse events do not get reported by medics. Most are not even noticed. There is no tradition of timelining the appearance of a problem and remarking any possible connection to the vaccine. Because the mantra ‘vaccines are safe’ is so embedded, both societally and medically, most in the medical fraternity struggle to envisage that a vaccine could have deleterious effects past the first 15 minutes of being injected. There is a collective spirit of self-censorship with respect to the Covid-jabs in particular. It is disquieting to say the least.
Members of the public, as well as healthcare professionals, are free to lodge a Yellow Card event at this site. Has every person getting the jab received clear instructions on how to do this? Did every individual really receive the information necessary to give informed consent? In a world where patient safety was the primary objective, this would be a bare minimum for an entirely novel medical product, particularly when being rolled out to millions of people at once. Were care home managers educated on the reporting system and trained in observing changes and possible symptoms? From enquiries made to care home managers, it seems this did not happen.
It is also possible to lodge an event on behalf of a relative you care for, or for an elderly relative who cannot perhaps navigate the labyrinthine online reporting system. When making the report, you can register so that any future reporting you do may be accessible by putting in your email and password to bring up the reporting system. However, you may lodge a report without doing this.
The online form is poorly designed. I know numerous computer-literate clinical colleagues who find it time-consuming and cumbersome. For something as simple as a headache one has to choose from 50 different types of headache. For insulin, 20 types. Such systems need to be simple and slick to avoid further unnecessary blocks for busy medics.
The issues cited above are reflected in the fact that adverse effects have been reported for only 0.3 per cent of Pfizer vaccinations and 0.5 per cent of AstraZeneca vaccinations. In their phase 1 and 2 trials, adverse events were reported at least 100 times more often (Pfizer 84 per cent pain, 63 per cent fatigue; AstraZeneca 50 per cent moderate symptoms). With these kind of percentages slipping through the cracks, it seems that the entire reporting system is in dire need of an overhaul.