Reports of Coronavirus vaccines being made available to the public before Christmas have abounded in recent weeks.
While heartening, it remains essential that long-term data is gathered. Not only to ensure safety and efficiency but also to maintain public assurance and confidence in the vaccination process.
Currently, the UK Government has 357m vaccine doses secured from seven different sources. All of these are at various trial stages with four already undertaking critical Phase III trials.
However, even if final approval is obtained, this should not be seen as an end to the pandemic and rather more as the start of a long road to mitigate its impact for good.
For this to happen, long-term data is essential.
Utilising a combination of randomised and controlled trials, alongside robust evidence gathered from large numbers of test participants over a prolonged period of time, regulators will be best placed to consult robust evidence of safety, effectiveness and efficiency when considering much-anticipated vaccines.
Investigators and sponsors will need to ensure they have well-developed strategies in place that continue to monitor vaccinated and control groups for as long as possible following regulatory approval.
In turn, this information should be used to inform further trials and the ongoing design and distribution of other vaccines.
This necessity has been recently recognised by the International Coalition of Medicines Regulatory Authorities (ICMRA) who issued a statement calling for COVID-19 vaccine clinical trials to be continued “for as long as feasible” to “collect critical data to support regulatory actions and deployment.”
The fight against Coronavirus is progressing well. However, to fully overcome it, we must invest in sustained research and development.
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