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COVID-19 vaccine approval shows MHRA's ability to adapt to a crisis

Posted on 3 December 2020

The announcement that the Medicine and Healthcare products Regulatory Agency (MHRA) had approved for use in the UK the Pfizer/BionTech vaccine has resulted in a near-euphoric reaction across the media in the UK and, this time, it may well be justified. Putting aside the inevitable puns around "shot in the arm" for the economy, the reality is that this long-awaited announcement really is (to repeat the already over-used expression) a game changer. Coupled with the role of a fully integrated health system that is the NHS, and that is used to implementing mass vaccination programmes, we may all now be able to glimpse some light at the end of what has been a very dark tunnel.

The expressions of national pride that the UK is "first" is something that should arguably be taken with a pinch of salt because of course this is not a British vaccine. However, the work of the MHRA must be applauded unreservedly. Throughout the COVID-19 crisis the regulator has shown an ability to react quickly, allowing for the delivery of PPE and a whole host of other measures to allow clinicians to effectively manage the crisis while – and this is extremely important – ensuring that the fundamentals of safety and efficacy of any measure to be adopted is not compromised.

In being the first regulator to approve the Pfizer/BionTech vaccine for use the regulator has stayed true to this approach. Questions will – reasonably – be asked about the integrity of the process given how long the process of development, testing, assessment and approval usually takes. These questions might be reasonable, but they are also easily answered. Not only is the MHRA one of the most respected and experienced regulators in the world; the vaccine was trialled with over 43,000 people. This is an extraordinarily large number of study subjects. To put this into context, a normal phase III interventional clinical trial will typically involve around 1,000 to 3,000 people. The task facing both the developer and the MHRA was then to work together to properly analyse this extremely large data set and, for the MHRA, interrogate and verify the results. For this to have been achieved in a short timeframe is a testament to the MHRA's ability to adapt to the circumstances while always protecting patient safety.

These processes are now no doubt being applied to the other vaccines seeking approval and will unquestionably lead to improvements and efficiencies for the approval process post the pandemic.

Of course, while this is absolutely positive news, a huge amount remains to be done to implement the vaccination programme. All of the vaccines in development will have a huge part to play and the logistics around manufacturing and delivering the vaccines in sufficient quantities to the primary care sector, in the UK and around the world, are daunting. There may also be challenges from vaccination critics, such as those we saw in our recent film made in partnership with The Economist, Vaccines: a dose of truth. But for now we can take considerable comfort from the fact that the process has begun.  

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