NHS reforms

UK outlines new measures to support vaccine development

A raft of new measures have been charted out by the UK government to further support the safe future mass rollout of a Covid-19 vaccine, as efforts continue to save lives and bring the current coronavirus pandemic to an end.

Improved access, bolstering of safeguards and an expanded workforce are among the proposals laid out to strengthen the UK’s position as a leading nation in the successful development and UK-wide deployment of a vaccine for the virus.

Steps have already been taken to ensure Covid-19 vaccines will be given to UK patients if stringently proven to be safe and effective.

The measures include:

• reinforced safeguards to support the Medicines and Healthcare products Regulatory Agency (MHRA) 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

Should a vaccine be discovered before 2021, the new proposals would bolster existing powers available to the Medicines and Healthcare products Regulatory Agency (MHRA) to consider approving its use, prior to a full product license being granted, provided it is proven to be safe and effective during robust and extensive clinical trials.

The new measures are significant as during the current Brexit transition period, a potential Covid-19 vaccine would require being granted a license 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 licensing process, with reinforced conditions attached to ensure safety, quality and efficacy. It has been proposed as a precautionary measure for use only as a last resort if there is a strong public health justification for widespread use of a vaccine ahead of the granting of a product license.

A three-week consultation has been launched, looking to amend the Human Medicine Regulations 2021 and will seek the opinions and advice on the proposals from health experts and key stakeholder groups.

Should they be approved, the new measures could come into force by October – ahead of the winter period.

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.”

From 2021, MHRA will have a national licensing system established and would be responsible for granting licences for potential Covid-19 vaccines and treatments once they meet strict safety and effectiveness standards.