A post by Domhnaill MacDo nchadha

 

I have spent more than 25 years as a senior Regulatory professional in the Life Sciences industry and in that time I’ve had the privilege of being involved in the development of, and approval of, life transforming innovations; it’s what excites me about going to work every day, be that in Europe, South East Asia or the Americas – the opportunity to contribute to the wellbeing of people in a time of need.

Vaccines are incredible things, they’re not drugs, like antibiotics, but they are developed and produced by pharmaceutical companies, perhaps that’s what is making some of us reticent to subscribe to the forthcoming vaccination campaign.

 

What a time to be in the industry, or so you might think. Being a Regulatory professional, it is my responsibility to be satisfied that sufficient steps have been taken to assure both the safety and efficacy of a product such that any inherent risk is understood, and that we can demonstrate that the benefit of treatment is sufficient so as to outweigh that risk. There are many products that fail to make it to market because they failed to pass that test, it’s all about risk versus benefit – more of that in a bit.

 

It was only a matter of time before a vaccine was created to deal with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the particular strain of the coronavirus that causes the disease we now refer to as Covid-19, that has left virtually no-one in our lives unaffected by it to some extent.

 

Truthfully there was very little interest in a vaccine for Covid-19 until it was realised that it was to explode beyond its point of origin and become a full-blown pandemic, and one that had the potential to wreak havoc on the global economy – It is that impact that fired the starting pistol to create a vaccine and, yes, some people are going to become very rich as a result, especially for those that are among the first get their vaccine approved. It became hugely political too, the US government led by President Trump pumped $2 billion in to a project to hasten the arrival of a vaccine – he stood to gain from being able to say that ‘he did it’, it became quite unedifying and from that point onwards there then began much suspicion and genuine worry that safety and/or efficacy (they are not one and the same.) may be casualties for the sake of a political race to secure re-election.

 

As it happens, the intervention of the Trump Administration was hugely beneficial but probably not as Trump intended. The Pharma industry is intensely competitive in creating vaccines and drugs (and their delivery mechanisms) ultimately pumping many tens of billions of $ dollars in to the global economy, this is a prestigious industry, the reward for being first and best is immense but it could not afford to become a political weapon in the US election – so what a surprise to see the big-guns come together and commit to setting aside some of that rivalry in order to work together to create a series of vaccines that would tackle this virus and help restore life and the economy, to some semblance of normality – capitalism was banking on it both literally and figuratively.

 

After many months in development, we now have a number of pharma companies claiming to have effective Covid-19 vaccines, and for the first time for many of us we are hearing of something called ribonucleic acids (mRNAs). Messenger RNA is exactly as its name suggests, at a molecular level it transmits (messages) to cells in our body instructing those cells to produce a specific protein and this can be used to fight certain diseases – This technology is one such development in the battle against certain cancer types. So, Pfizer and others such as Moderna are using this relatively new development base to rapidly synthesise the protein spike associated with Covid-19 in order to neutralise it. Some people are understandable concerned about the pace of this development and how quickly it has come to market readiness – some of those concerns are well-founded whilst some are not. Simultaneously we have other pharma companies, such as AstraZeneca, developing a vaccine using the more ‘traditional’ method where a weakened or inactive antigen is introduced to the body and our immune system sets about creating antibodies to fight the unwanted intruder. AstraZeneca has come under fire in some quarters for their ‘average’ efficacy being ‘only’ 70%. We would be well served to remember that the Regulators set the efficacy figure for the vaccine at 50% – the same as that for the flu vaccine, and after all there has been no shortage of commentators telling us that Covid-19 is just like the flu. One encouraging aspect of the more traditional vaccine type created by AstraZeneca is that it has performed extremely well in groups considered most vulnerable, such as the elderly Remember the old tale of the race between the hare and the tortoise? First to market in this particular race may not necessarily be the outright winner when all is said and done.

 

Whichever method for vaccine creation is used there are questions that we must rightly be provided answers to in order that the uptake of the vaccine is sufficient to break its rate of transmission, and it is here, that for me at least, the jury is out.

 

I am not yet clear, given the lack of peer review, and remaining questions from regulators, that enough is yet known. The media have latched on to the press releases from the pharma companies on the wonder-vaccines that they have developed, and I seek not to detract from their remarkable achievements, but a poor vaccine is no better than no vaccine at all – indeed, it could be much worse.

 

We know that both Pfizer and Moderna have had significant manufacturing issues in upscaling their processes to produce the vaccine, the supply-chain for certain elements of the vaccine have been unable to cope, and the cold-chain for the Pfizer vaccine continues to be a limiting factor in its availability. In the last few days there have been allegations made of a State actor being involved in a cyber-attack on the Pfizer system used for monitoring its cold storage distribution capability, there are well documented concerns of shipments of vaccine being targeted by criminal gangs. But beyond this there remain other questions. We are not yet clear as to the period of protection that the vaccine will afford – it is unknown if it will be 6 months, or more, or less. We have absolutely no understanding, yet, if either safety or effectivity are compromised when used in conjunction with other vaccines (influenza, MMR etc.) or prescribed drugs. We have no real understanding yet as regards the scale and scope of reactogenicity – during the studies a number of study participants had quite painful and distressing reactions to the vaccines (the Pfizer study being suspended for a period), far beyond a soreness localised the injection site. We have absolutely no idea yet as to the impact of the vaccines for those who are already immunocompromised. We have no credible lengthy study showing the consequences of the mRNA vaccine over time and in large numbers that reflect the true population. The Moderna study was limited to the USA, even though ethnic minorities participated there are widely held concerns that they were insufficient in number to be of significance, furthermore we know that Moderna are being forced to defend the patent of their vaccine technology. The effect of annual flu-jabs are a topic of much discussion – studies are presenting data that annual flu-jabs is actually resulting in the antibodies decaying over time but remaining in our systems such that they can attack future infections but may attack specific elements of a new vaccine and thus render is significantly less effective. Our insatiable appetite for the flu vaccine may yet come to haunt future generations in a way not dissimilar to the indiscriminate and prolific use of antibiotics throughout the 60’s-80’s.

 

We also know now that the Boris Johnson government are turning the UK in to one large clinical study – the UK regulator, the MHRA, a body that has on more than one occasion stunned me in their lack of understanding in matters technical, has granted Pfizer a ‘emergency-use authorisation’, with considerable indemnity granted, on the basis that they have ‘actively reviewed study data as it became available’.Make of it what you will, but no other nation enduring this crisis has afforded any manufacturer such an authorisation despite having the legislative authority to do so despite being in possession of the very same data.

 

So, what am I going to do? I applaud the industry for the speed at which it has engineered these latest vaccines, but I’m going to wait, I remain to be convinced on the risk ‘v’ benefit. Let’s also not forget that we have other manufacturers still undertaking trials on large populations: Johnson & Johnson, Sanofi, and others. Covid-19 is a remarkably easy virus to kill, soap and water coupled with exercising good hygiene practice is extremely effective but alas we can’t all seem to abide by those simple requirements because of ‘inconvenience’, so I am resigned to wearing a facemask and sanitising routinely until such times as the data exists to convince me that not only is the Covid-19 vaccine effective but that it is also safe beyond Covid. We will most likely succeed in reducing Covid-19 to an inconvenience in the next eighteen months, however there shall be other viral infections in the years ahead, this experience is sadly one that we are likely to repeat in our lifetime if we chose to continue to live our lives as we have become accustomed to in the last 6 decades where there is barely a corner of the globe in to which we cannot reach for pleasure or trade.