The gold rush pales in comparison to the race to get a safe and effective vaccine for coronavirus (COVID-19) on the market. But what people really want to know, is who is going to be the first and is it going to be the UK?

Will the UK Win the Race?
Firstly, it will not. Why? Because a vaccine for coronavirus (COVID-19) has already been administered in both China (to military personnel by CanSino Biologics Inc) and Russia, which has publically announced a goal to start mass inoculations in October. However, both vaccines have caused concern in the scientific community due to the speed at which the vaccines have been produced and used in human candidates. As a result, there is concern that these alleged vaccines will not, in fact, provide the protection claimed.

Secondly, getting a vaccine to market is not a simple task. As a 'standard' route to market, any vaccine candidate must pass three phase trials:

  • Phase I to test the vaccine on a small number of human subjects with a view to determine adverse effects and dosage.
  • Phase II to confirm that the vaccine stimulates the required immune response.
  • Conduct large scale trials to ensure that the immune response results in protection across the population, otherwise known as a Phase III trial.

If the data shows that the vaccine candidate has achieved these milestones, it must then go through rigorous regulatory scrutiny before considered both safe and effective for public use. The questions are therefore:

  • How long this process will take?
  • Will the vaccine candidate make it through all three phases?
  • Will the regulators approve it, and what conditions may be set on such approval?

As the pressure on countries to release information on vaccine candidates increases, the rumour mill is rife with hints at regulatory hurdles being by-passed, the UK branching out on its own away from EU regulators before the end of the Brexit transition period and trials being rushed forward and what this means from a safety perspective (if anything).

Thirdly, we are in uncharted territory here. There has never been such a global need, and desire, for a vaccine here and now. As a result, whilst regulators are keen to support this much-needed research and testing as the global economy shrinks with a deep recession, their ultimate, and most sacred, responsibility is not forgotten - to keep the public, and patients, safe. This is a difficult balancing act and one which the regulatory bodies of the world have not yet experienced in their lifetime. We therefore enter uncertain times and wait to hear what the governments and regulators decide.

What About the Pharmaceutical Companies Which Will Ultimately Roll out the Vaccine?
In particular, what about a vaccine that has been developed at lightning speed in an innovative regulatory framework?

The need to get this vaccine to the people that need it is intense, the gravity of government weighty, and yet the scientists who develop these amazing medicines want to ensure safety and effectiveness above all. So who takes the ultimate responsibility for vaccines produced quickly in order to save lives? A question which is yet to be answered.

The UK's Battle Against Coronavirus
The UK is a pioneer of medical innovation and we are fortunate to have both a broad range of world class organisations and academic institutions focused on the global goal to get a vaccine for COVID-19 to the people that need it. The AstraZeneca and Oxford venture has highlighted what amazing things collaborations can do and how hard people work to get us the medicines we need, when we need them. No matter the outcome of the many vaccine trials in the UK, the response by our scientists, pharmaceutical organisations, academic institutions, charities and regulators, has shown how when we need to work together, we do and we do it well.

Do you work on clinical trials or otherwise need specialist legal advice for your pharmaceutical or life sciences organisation? Please contact Laura Barrell in our Pharmaceuticals & Life Sciences team on 07775 518585