MHRA chief executive June Raine has been keen to stress that "no corners have been cut" in the approval of the world's first Covid vaccine.
A little over a week since the MHRA, the UK’s medicines regulator, registered receipt of the vaccine data put forward by Pfizer/BioNTech, it has given the Covid jab the green light for use in the UK.
Its vaccine, which requires two doses per person, has an efficacy of up to 95% in the fight against Covid, leading to an application for approval from UK regulators on 23 November.
Dr Raine said: “We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.”
What does MHRA stand for?
MHRA stands for the Medicines and Healthcare products Regulatory Agency.
It is part of the UK’s Department of Health and Social Care and is responsible for regulating all medicines, medical devices and blood components for transfusion within the UK.
It ensures the safety, quality and effectiveness of medicines and equipment through rigorous testing and standards procedures to protect and maintain public health.
The agency also incorporates the National Institute for Biological Standards and Control (NIBSC), a global leader in the standardisation and control of biological medicines, and the Clinical Practice Research Datalink (CPRD), a data research service.
What does the MHRA do?
The MHRA is a government agency responsible for making sure all medicines and devices are safe to use and meet the necessary safety and quality standards.
Medicines, from a plaster to a vaccine, need to obtain a licence from the MHRA before being sold or used in the UK.
It also has a role in promoting international standards and harmony, helping to educate the public and healthcare professionals and support innovation and research.
The MHRA also has a part to play in protecting the public from misinformation or fake products, with patients or doctors able to record any issues which may require further investigation from the medicines regulator through the Yellow Card scheme.
What role did MHRA have in Pfizer vaccine?
The MHRA has approved the use of the Pfizer vaccine in the UK.
Its decision to approve the vaccine was made with the advice of the government’s independent expert scientific advisory body, known as the Commission on Human Medicines (CHM).
The MHRA had been tracking the Pfizer jab since June before scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data in October.
The agency’s dedicated team reviewed every step of the development process from pre-clinical studies, clinical studies, manufacturing and quality controls data.
It also reviewed data from the product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
Vaccines typically take years to develop yet through using a regulatory process known as a ‘rolling review’ the assessments were able to be completed on a staggered basis.
This is sometimes done to speeden up the timeframe during a public health emergency, such as the coronavirus pandemic, and the MHRA is keen to stress that “no corners were cut”.
What has the MHRA said on the Pfizer jab?
Chief executive Dr June Raine was keen to stress the high standards maintained by the MHRA.
She said: “We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.
“I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way - and in helping to save lives.
“We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine.
“Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.
“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.”
Who is Dr June Raine?
Dr Raine has more than 35 years of experience in medicine.
An Oxford University graduate, she is a member of the Royal Colleges of Physicians and joined the Medicines Division in 1985. She has since worked on several licensing areas, including the review of medicines and new drugs.
Prior to taking the top post at the MHRA, Dr Raine was director of vigilance and risk management of medicines for 20 years.
What happens now?
Part of the agency, the National Institute for Biological Standards and Control (NIBSC), will continue its testing to ensure the vaccine meets the expected standards of safety and quality.
The UK is the first country in the world to approve the Pfizer vaccine and is expected to receive 800,000 doses, paving the way for mass rollout in the week commencing 7 December.
The UK’s Vaccination Taskforce has acquired 40 million doses of the Pfizer jab overall - enough for 20 million people to receive two doses of the vaccine taken 21 days apart.
Pfizer has been at the forefront of developing a vaccine against the virus and registered high efficacy results in November - raising hopes of an end to the current global pandemic.
Older adult residents in care homes and care home workers, patients over the age of 80 and health and social care workers will be first in line when the vaccine rollout begins.
It will then move to over 75s, over 70s, over 65s, high risk adults under 65, moderate risk adults under 65, over 60s, over 55s, over 50s then the rest of the population.