A raft of measures to allow the safe future mass rollout of a Covid-19 vaccine have been outlined by the government.
The new rules and safeguards will strengthen the UK’s ability to successfully deploy a UK-wide vaccination programme, which will be crucial in saving lives and bringing the current pandemic to an end.
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 – provided it meets the highest safety and quality standards
• Expanding the trained workforce who can administer Covid-19 and flu vaccines to improve access and protect the public
• Clarifying the scope of the protection from civil liability for the additional workforce that could be allowed to administer vaccinations
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 measures are necessary because during the transition period, a new potential Covid-19 vaccine must be granted a licence by the European Medicines Agency (EMA).
The regulations will permit the MHRA to consider giving temporary authorisation allowing patients to benefit while it undergoes the full licencing 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.
From 2021, MHRA will have a national licencing system in place and will be responsible for granting licenses for potential Covid-19 vaccines and treatments once they meet high standards of safety and effectiveness.
Deputy chief medical officer, professor Jonathan Van-Tam, said: “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.
“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.”
The MHRA has the power to grant an unlicensed medicine or a vaccine temporary authorisation where a product is proven to be safe and effective and is in the best interest of the patient on the basis of available evidence.