The government have announced new measures to support the deployment if COVID-19 vaccines along side a consultation on amending the Human Medicine Regulations 2012 to speed up deployment.
Steve Bates, CEO of the U.K. Bioindustry Association, said:
“The BIA looks forward to submitting expert opinion to the government’s consultation on enhancing specific medicines regulation for rapidly developed vaccine candidates against the pandemic threat. It’s testament to the expertise of UK regulators that they are thinking through now, and publicly consulting on, the complex detail of how to best oversee and manage the approval and deployment of any of the COVID-19 vaccine candidates which are being developed at unprecedented speed. An enhanced clause 174 may well become a crucial regulation at a crucial time.
“As the development of COVID-19 vaccines and the end of the transition period are now happening at the same time, we urgently need the government to publish the detail of how medicines regulation will work under the already agreed Northern Ireland protocol, so that industry is able to fully respond to this consultation. Agreement of an EU/UK deal covering medicine regulation would further enhance certainty for medicine supply chains underpinning vaccine development for the UK and the EU.”
Dr Ohid Yaqub, Senior Lecturer at the SPRU (Science Policy Research Unit), University of Sussex, said:
“The government consultation released today shows some of the thought and preparation going into the deployment of a possible COVID-19 vaccine. Its main purpose is to give the government the option to authorise a vaccine before it is licensed by the European regulator (the EMA) and laying down some of the legal groundwork to do so. If the government chooses to exercise this option, it would help public confidence if the government commits to fully disclosing its reasons for regulatory divergence from the EMA’s decision-making, especially in its interpretation of safety and efficacy.”
Dr Doug Brown, Chief Executive of the British Society for Immunology, said:
“New vaccines need to go through many safety checks before they are licensed for public use and any potential COVID-19 vaccine will be no different. Today’s announcement sees the government empower the MHRA (Medicines and Healthcare products Regulatory Agency) as it prepares to transition to a role where it gains new authorisation and licensing powers after Brexit. These steps will help to ensure that the UK can benefit from a COVID-19 vaccine should one become available in the near future that is proven to be safe and effective.
“Providing vaccination services and ensuring these services are accessible and promote high uptake is an extremely complex task which requires significant resources. A focus on increasing the vaccination workforce, particularly with regards this year’s extended flu vaccination programme and any potential future COVID-19 vaccine, is a positive move. This will maximise opportunities for people to receive each vaccine and help guard the future health of the nation. To reap the significant benefits that a focus on vaccination can deliver, we hope this welcome injection of funding will extend across all our vaccination services, including the childhood vaccination programme, where the UK still does not reach the required 95% uptake rate. We need to ensure that our communities are protected against all preventable infectious diseases.”
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Dr Ohid Yaqub: “No conflicts of interest.”
Dr Doug Brown: “Dr Brown is a trustee of the Association of Medical Research Charities (AMRC).”
None others received.