The MHRA, EMA and FDA have different procedures which need to be completed before they can take a decision on an application for use of a new drug/vaccine. So, why is the UK’s MHRA the first in the world to approve a COVID-19 vaccine? It could have something to do with the UK exiting the EU. The Freelance Informer reports.
For example, the FDA rule requires the agency to complete an internal assessment and to consult an external advisory board prior to making a decision. While not strictly required for emergency use authorisation, because of the public health implications of potential very widespread use of a vaccine, the FDA has already stated that this will form part of their actions on receipt of the file. The ad boards will be held on Dec 10th for the Pfizer and Dec 17th for the Moderna vaccines, according to the medical press.
The EMA has a much arduous task, according to Dr Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London and Chair of the Education and Standards Committee of the Faculty of Pharmaceutical Medicine.
“The EMA has to align independent view from 27 separate member states.”
Dr Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London and Chair of the Education and Standards Committee of the Faculty of Pharmaceutical Medicine
“They do this by consulting the Committee on Human Medicinal Products (CHMP) which has fixed meeting dates set throughout the year.” said Ward.
She continued, “They have been conducting a ‘rolling review’ of the documentation for all three vaccines so they are moving much faster than usual – their usual process to the first CHMP discussion for a ‘normal’ appraisal takes 180 days (6 months) with a potential further 6 months if there are questions (which there usually are, even for conditional approval applications).”
The MHRA, according to Ward, similarly has been reviewing the documentation and have been permitted to take unilateral decisions as the UK is exiting the EU on Dec 31; this was written into the UK emergency legislation.
“The MHRA are a very efficient organisation and have been reviewing all the same information as the EU will have received. Unlike the EMA, they can ask questions as they go and obtain responses faster as a single agency. They will also consult their specialist committee, the Committee on Human Medicines and this committee can meet ad hoc as well as at fixed timescales,” she said.
Ward also added that the UK has also used their early access schema as a means to permit early access to potentially useful medicines for this pandemic and this offers a fast route to initial authorisation.
Rural areas could see delays
As previously reported by The Freelance Informer, approval for use is of course only the first step, then the product has to be actually manufactured, shipped and stored at freezing temperatures, which many GPs and even hospitals do not have the infrastructure, such as the fridges to store the vaccines, at the time of writing.
“This may prove to be more challenging but the willingness of the vaccine task force, the support of the operation warp speed and CEPI monies have all supported the massive expansion of manufacturing ‘at risk’ so that large quantities can be supplied as rapidly as possible,” says Ward.
Rural areas are anticipated to see the longest delays due to distances between surgeries, hospitals and other health services, not to mention a lack of cold storage infrastructure.
Professor Arne Akbar, President of the British Society for Immunology, said, the announcement of the Pfizer vaccine rollout for next week is “not the end of the story” and there is still much work to do.
“Roll out of the vaccine is going to be a logistical challenge and rely on our dedicated healthcare professionals around the country, said Akbar.
Public confidence yet to be tested
Additionally, building public confidence in the vaccine is going to be crucial in ensuring the high uptake needed to stop the spread of SARS-CoV-2 within our communities.
“It is essential that we have high profile and multifaceted engagement campaigns that listen and respond to the public’s questions around the vaccine,” said Akbar.