It was the moment everyone had been dreading, a joint announcement by the CDC and FDA that the Johnson and Johnsen vaccine was being temporarily withdrawn from circulation. The reason given? Six adverse reactions resulting in one death from an extremely rare blood clotting disease.
This adenovirus vaccine from J&J has proven itself extremely effective at preventing serious Covid that results in death. It has also shown increased efficacy in South Africa against their troublesome local strain of coronavirus, the B1.35.1 variant. On top of this, the J&J vaccine is a single shot (no follow-up shot is required) and it doesn’t have to be transported by frozen polar bears. Simple refrigeration suffices.
For poorer third world countries, this far cheaper, easily stored, and transported, single application vaccine is a godsend. Its also considerably cheaper, always an issue in developing countries where healthcare budgets are tight. With all this in mind, the reaction by governments worldwide to the handful of adverse reports and deaths, for both this and the AstraZeneca virus (also an adenovirus vaccine) have been in keeping with the general PR fiasco surrounding Covid.
An absolute and complete PR fiasco
When determining risk, all vaccines have to pass rigorous safety trials. Over a period of time, often years, deaths will be an inevitable part of the administration of almost every vaccine we manufacture. Patients dying from unusual and isolated reactions to medication are hugely unfortunate but expected and accepted risks. If however, those deaths exceed a previously determined level, set by regulatory authorities on a country by country basis, drugs and vaccines are withdrawn from the market.
America may accept one death in a million as an acceptable risk, where Germany may consider a figure of 1.3 per million acceptable and the UK may draw the line at 0.8 per million. The one constant in all of this is someone, somewhere, will die, particularly with an increase in the number of patients the drug is administered to. An unpleasant, unavoidable, level of risk, made acceptable by the benefit the vaccine or drug confers on the general public. There are no perfect solutions in medicine.
The current risk ratio for the J&J vaccine, based on the 6 reported instances of patients affected by these rare blood clots is around 0.16 people per million. As of the 12th of April, according to the CDC, nearly 7 million J&J vaccines had been administered in the US. Let’s compare this with the risk profile for an individual who is immune-compromised, diabetic, obese, or suffers from any of the risk factors highlighted for developing serious Covid.
As there are no really reliable figures for this, let’s use the following flawed logic. We’ll use the known Covid deaths versus the US total population. That gives you a figure of approximately 1697 people in every million (560 000 deaths, approx population 330 million)that are likely to die from Covid. Now we know that most under 45’s don’t die from covid, deaths are concentrated in the older age groups and in at-risk populations, so realistically, that figure becomes higher. Much higher. You could probably comfortably double or even quadruple it for a more fair risk evaluation.
Compare these odds of dying from Covid to the possibility of dying from a rare blood clotting disease, which, coincidentally may also have proved fatal to these patients were they to contract the natural virus, we don’t know, For an at-risk patient, making an informed decision and exercising their right to choose, that 0.16 in a million queue looks more attractive by the minute.
The same logic can easily be applied to AstraZeneca and I would assume the associated risks would balance out in much the same way they have for Johnson and Johnson. The problem we now face is that none of this matters any longer. Both Johnson & Johnson and AstraZeneca have effectively been sidelined by bungling bureaucracy. Neither vaccine is available and a ‘temporary hold’ is in effect for distribution. In terms of the long-term damage to the public’s perception of the two brands, that is unknown at this stage.
Never before has the light of public scrutiny and accountability shone so brightly on the healthcare industry and its regulators. Like a pack of circling hyenas, the press and public wait, ever hopeful that the FDA, the CDC, or their European cousins will overstep their mark. Anti-vaccination pressure has added to the hysteria and the end result has been kneejerk PR. Reaction instead of action, quickly issued statements and poorly thought-through policies designed to appease fractious minorities, rather than serving the larger public interest.
The AstraZeneca and Johnson & Johnson vaccines are textbook examples of how poor decision-making and public-facing policy can impact and override the healthcare needs of the broader public.
Our regulatory organizations work for all of us, and it is their duty, first and foremost, to ensure all our interests are considered, equitably.
Identifying possible strategic blunders
A contributing factor to the PR and policy chaos is undoubtedly the much-proclaimed theory of achieving herd immunity at any cost. To this end, everyone needs to be vaccinated. This policy extends to all sectors of the community, children, healthy adults, and the populations identified as being at risk. There were a few glaring flaws in this policy, right from the outset, most notably the fact that between 30–60% of individuals, depending on which country and which news channels you prefer, are vocally opposed to being vaccinated. Whether through mistrust, misinformation or simple vaccine hesitancy, is irrelevant.
Vaccine hesitancy percentages were and are high enough to ensure that achieving herd immunity through vaccination alone was never a viable reality. I raise this issue as it relates directly to risk and accountability. Encouraging/forcing your healthy and younger populations to vaccinate engages a whole new dynamic and it’s one that’s backfired spectacularly on governments. Sadly, the biggest victims have been the vaccines themselves.
The risk ratios I described above are hugely acceptable for individuals that face a real threat from developing serious Covid. In fact, most at-risk populations would probably happily accept even higher ratios without question, only too glad for the opportunity to avoid the life-threatening conditions associated with serious Covid. Not so if you are healthy. Not so if you are really young and healthy. These patients do face a small risk, but that risk profile is in actual fact, unknown and unquantified.
Vaccinate this healthy population and you better ensure your vaccine is foolproof, as you’re potentially exposing a healthy person to the risk of death, however slim that risk may be. Apparently, according to the CDC and FDA, 6 out of 6.8 million is way more risk than they’re willing to go with, particularly as that risk is narrowed to the exact age demographic that can argue they don’t require vaccination. The real victims of this ‘risk assessment policy’ are the at-risk patients and the vaccines.
Were the vaccines designated for the at-risk segments of our population only, we probably wouldn’t be having this conversation right now. People, in general, are averse to the idea of dying and willing to accept an accompanying risk to avoid it.
Rethinking the path forward
Restoring confidence in these vaccines will fall to the media whose track record is at best questionable, each network differing in the narratives they transmit to the public, and the government’s own narrative has become so disjointed as to appear, unreliable to the general public. I watched with interest today as Eric Topol, one of the countries eminent virologists, spoke on CNN, in defense of the Johnson and Johnson vaccine and echoed our sentiments.
Immediately resume vaccination of the at-risk sectors of our population with the adenovirus vaccines. They are safe. Not foolproof, but safe within expected limits.
It may be time to fundamentally rethink our global vaccination strategy, for a number of reasons. There is an alternate path moving forward that would allow the vaccines to rebuild and repair their tarnished reputations and would address global vaccination disparity, an issue of increasing concern as many countries are yet to begin vaccination. To achieve this we should consider the first crucial flaw in our current system.
Immediately stop vaccinating the naturally immune
We have limited time and limited vaccines to address a global population, that is, almost to a man ad woman, at risk of contracting the SARS-CoV2 virus. Many have already contracted the virus. Our fallible statistics tell us that as of today, we’ve confirmed 138 million via testing. Realistically, actual infection rates are probably far closer to 500 million, with many untested and asymptomatic infections.
That equates to 500 million spare vaccines, half a billion people we don’t need to vaccinate, they are naturally immune and while we can stand here arguing till the sun goes down about the benefits of vaccinated versus natural immunity, the clock carries on ticking away. Immune is immune, by whatever method. Neither is perfect and either is acceptable. It is also, crucially, 500 million fewer people to add into the herd immunity calculations.
The next logical question this approach raises is how do we tell who is immune and who isn’t? This would require testing at the point of vaccination or possibly offsite. A simple test able to return an immediate result for SARS-CoV2 antibodies. No antibodies, roll up your sleeve. If you’ve natural immunity, smile, thank the nurse, and get on with your day.
This is a realistic and viable path towards reducing the impact of Covid globally. It will increase vaccine availability and ensure that the at-risk populations we innoculate are really in need of the vaccine, further justifying whatever minimal risk is involved. This is patient-focused medicine on a global scale, allowing us to free up much-needed vaccine stock for third-world countries. We cannot vaccinate the entire American population and expect that countries with no access to vaccines aren’t going to simply re-infect us with new variants.
Adopting this strategy would also have the immediate effect of restoring faith in the vaccination process. No political agendas linked to immunity passports and enforcing vaccination, just policies driven by efficient administration to protect our global populations. With clear, distinct, and transparent policies the public can understand and relate to, everything else will follow.
Our first steps now are to restore credibility to the two amazing and effective vaccines we have so seriously undermined in the public mind. We can ill afford to be choosy at this point in the pandemic and failure to address this now may very well return to haunt us in the coming months.
April 17. 2021: The risk figures quoted in the original article were in fact incorrect. These have been adjusted now to accurately reflect a risk rate of death from Covid in the general population in the US: 1697 in a million people. Our thanks to Philip Deane for highlighting this glaring error.