Would you be comfortable taking a vaccine that has gone through clinical trials this quickly..? That was the question posed by one of my colleagues following the recent MHRA approval for the Pfizer/BioNTech mRNA vaccine. “Very happy…” I replied. And here’s why….
As an undergraduate in the mid 90s, I worked at an up-and-coming Biotech during my sandwich year. The project that I was involved in was to develop a cervical cancer vaccine, now given routinely to UK girls who are reaching their early teens (in my opinion, it should be given to boys too). My role was to grow litres of E.coli bacteria to produce the proteins that are seen in the most common forms of Human Papillomavirus (HPV). This protein was developed into the vaccine which, when administered, would illicit an immune response, protecting the recipient from the primary cause of the cancer.
Whilst I was involved in the R&D of this vaccine, admittedly a very specific step of the pre-clinical process, I can report that I was never asked to add microchips to the products. I was not part of “Big Pharma’s” plan to take over the world. I was proud that the work I was doing could one day help to thwart a preventable disease and make the world a better place. Everyone that I have met who is involved in Pharma feels the same way. I have never met Bill Gates (although I would love to)!
In another role, I have also worked with Pharmaceutical and Biotech companies who are seeking regulatory approval for their drugs. The road is long and bumpy, but I am happy to confirm from my experience that the approval is based on evidence and data – nothing else. For example, the submission of clinical data is reviewed, a health economic analysis is carried out, patient safety and efficacy is paramount, strict manufacturing steps are scrutinised… the list is long, the submission files are weighty and the inspection by the regulatory experts is rigorous. If a drug has been approved for use, the data and evidence will have demonstrated that it is safe, reasonably priced and that it works. But it doesn’t stop there, as anyone who has read the leaflet that comes with their medicines knows, any “adverse events” must be reported and this will be considered by the regulators in real time, with the drug’s use suspended if concerns remain; this is a fluid and ongoing process to ensure transparency and accountability.
In the case of the COVID vaccines, there is an obvious public interest in approving their use. With this interest comes funding and an abundance of volunteers. Many of the clinical trials could be run in parallel rather than sequentially because of this. The clinical data was properly curated and the regulators were able to look at this in near real time. All of this helped in the rapid turnaround because the clinical data was robust and the approval was as safe as any other. The rapid development and approval of the vaccine, hopefully vaccines, is testament to the life science industry as a whole.
I was heartened to see that MHRA warning immediately after two adverse reactions on the first day of the vaccine; that means that the process is working, it is fluid and it is evidence based.
At Grovelands, we specialise in supplying IT/ IS data experts to the Pharma and Biotech world. We know that data is crucial and we are here to help you to resource the right specialist at the right time to ensure the best for your business. Please reach out if you would like to discuss this further.