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They include expanding the trained workforce who can administer Covid-19 and flu vaccines, and reinforced standards to support the Medicines and Healthcare products Regulatory Agency (MHRA) to grant temporary authorisation for the use of a new Covid-19 vaccine.
They will also clarify any protection from civil liability for the additional workforce administering 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.
This is provided it is proven to be safe and effective during clinical trials. The measures are necessary because during the transition period, a 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.
This 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, the MHRA will have a national licencing system in place and will be responsible for granting licences for potential vaccines and treatments once they meet standards of safety and effectiveness.
“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.”
On Friday a three-week consultation was launched to look at amending the Human Medicine Regulations 2012, seeking opinions and advice from health experts and key stakeholders.
The measures could come into force by October, ahead of the winter season, the Department of Health and Social Care said.
The latest restaurant due to close its doors because of the coronavirus pandemic is Wahaca.
— The Guide Liverpool (@TheGuideLpool) August 27, 2020
“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.”
Under the proposals more fully trained healthcare professionals will be able to administer vaccines under NHS and local authority occupational health schemes, as well as enable an expanded workforce that can administer vaccinations.
This will make it easier and quicker for patients to access the vaccines. The expanded workforce could include a wider range of existing NHS staff, as well as groups such as student doctors and nurses.
The regulations already give healthcare workers and manufacturers protection from civil liability, but the consultation will look at clarifying the scope of the protection to ensure it applies to companies that order the medicines and the additional workforce that could be allowed to administer vaccinations.
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