Student doctors, nurses and other medical professionals could be recruited to administer a new coronavirus vaccine. The government announced on Friday it wants to change the law to dramatically increase the size of the workforce entitled to issue injections.
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 government is currently backing six different vaccine candidates, and has placed orders for 340 million doses, to be used if and when a drug passes its safety and efficiency hurdles.
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.
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.
A consultation was launched on last Friday to last three weeks, which will look to amend the Human Medicine Regulations 2012, seeking the opinions and advice on the proposals from health experts and key stakeholder groups. The consultation will also look at clarifying the scope of the protection from civil liability, which the regulations already give to healthcare workers and manufacturers, to ensure it applies to the companies which order the medicines and the additional workforce that could be allowed to administer vaccinations.
The measures could come into force by October, ahead of the winter season.
Deputy Chief Medical Officer Professor Jonathan Van-Tam told Asian Voice, “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.”
Dr Christian Schneider, Director of National Institute for Biological Standards and Control (NIBSC) - part of the MHRA – said, “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.
“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.”
