On Wednesday my agency, the MHRA, announced the authorisation of the Pfizer/Biontech Covid-19 vaccine for supply in the UK, making the country the first in the western hemisphere to issue an approval.
People rightly ask me how we achieved this outcome before others.
While the first batch of data from Pfizer was not submitted to us until early October, preparation began months before.
In June we set up an independent expert working group to take safety work forward, and another group was formed in August. These include 48 experts from outside of the MHRA: virologists, toxicologists, epidemiologists and immunologists.
In September we prepared laboratories for independent batch testing, to be carried out by the National Institute for Biological Standards and Control, part of the MHRA. Before any batch can reach the public, the institute checks that it is consistent with results for batches previously shown to be safe and effective. This work began last month.
From October Pfizer/Biontech sent us submissions of data on a rolling basis. This review has been key — it is a regulatory tool that allows us to see the data as they become available rather than waiting to consider it all at once.
It meant that we had made good progress by November 23, when the final data submission was sent to us.
I think of it like climbing a mountain: months of preparation, ready at the base camp when the interim data arrive, and ready to scale the peak when the final package arrives.
As the data came in, our experts reviewed it with rigour. We pored over pages of data, looking at everything from laboratory studies to clinical trials and more. We looked at how the vaccine protects people from Covid-19 and how long for. We analysed the data on safety, its stability and how it needs to be stored. Our assessors have worked around the clock.
We also have inspectors working to international standards, viewing the sites used across the life-cycle of the vaccine, from initial development in a lab to manufacture and distribution.
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Of course, no stone should be left unturned. So, once we have reviewed the data, we seek advice from the Commission on Human Medicines, the government’s independent advisory body. It too critically assesses the data before advising on the safety, quality and effectiveness of any vaccine.
On December 1 the Department of Health and Social Care asked us to authorise the Pfizer/Biontech vaccine under Regulation 174, an EU provision enshrined in national law that allows for the authorisation of a medicine in response to a public health need.
This meant that instead of having to go through the European Medicines Agency (as most vaccines do until the end of the transition period), we could authorise the vaccine based on public health need, so long as the batches met specific conditions laid out by us.
For those concerned, I can assure you without reservation that the standards we have worked to are equivalent to those around the world — no corners have been cut.
Our work does not end there. The MHRA has responsibility in law to continuously evaluate the safety of all medicinal products in the UK market. While this battle is in no way over, I hope that this decision, underpinned by months of analysis, will bring hope to those who have seen some of their darker days during this pandemic.
I also owe a huge debt of thanks to all those whose expertise, dedication and inspiring work have brought us this far on our journey.
Dr June Raine is chief executive of the Medicines and Healthcare products Regulatory Agency