A range of plans to ensure the safe future mass rollout of a COVID-19 vaccine have been announced by the government.
The measures include reinforced safeguards to support the Medicines and Healthcare products Regulatory Agency to grant temporary authorisation for the use of a new COVID-19 vaccine; expanding the trained workforce who can administer COVID-19 and flu vaccines to improve access and protect the public; and clarifying the scope of the protection from civil liability for the additional workforce that could be allowed to administer vaccinations.
‘We are making progress in developing COVID-19 vaccines which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future,’ said Deputy Chief Medical Officer, Professor Jonathan Van-Tam.
‘If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met. The proposals consulted on today suggest ways to improve access and ensure as many people are protected from COVID-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.’
If a vaccine is discovered before 2021, the proposals will bolster existing powers that allow the MHRA to consider approving its use, before a full product licence is granted, provided it is proven to be safe and effective during robust and extensive clinical trials.
The regulations will permit the MHRA to consider giving temporary authorisation allowing patients to benefit while it undergoes the full licensing process, with reinforced conditions attached to ensure safety, quality and efficacy. This is a precautionary measure and will be used as a last resort if there is a strong public health justification for widespread use of a vaccine before it has been granted a product licence.
‘Protecting health and saving lives is at the heart of all our work. Throughout the pandemic, the MHRA has prioritised work to ensure rapid approval of robust clinical trials to test a range of medicines and vaccines, whilst maintaining the highest quality and safety standards,’ said Dr Christian Schneider, Director of National Institute for Biological Standards and Control, part of the MHRA.
‘Whilst the existing licensing system, or a new UK one from next year, is the preferred and expected route to supply any vaccine, these new measures will strengthen the regulatory regime and our ability to protect public health.’