By Integrated Care Journal-
The UK Government has outlined new measures to allow the future mass rollout of a Covid-19 vaccine.
The new rules are aimed at strengthening the UK’s ability to successfully deploy a UK-wide vaccination programme.
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 protection from civil liability for the additional workforce that could be allowed to administer vaccinations.
So far, according to the Government’s figures, the virus in the UK has claimed 41,501 lives with more than 335,000 people tested positive for Covid-19.
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 licensing process.
Professor Jonathan Van-Tam, Deputy Chief Medical Officer, argued that if an effective vaccine is developed, it is extremely important that this is made available to the public as quickly as possible, but “only once strict safety standards have been met,” he said.
Dr Christian Schneider, Director of National Institute for Biological Standards and Control (NIBSC), said: “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. ”
The proposals will also allow more fully trained healthcare professionals to administer vaccines under NHS and local authority occupational health schemes, as well as facilitating an expanded workforce that can administer vaccinations to the public.
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