The Medicines and Healthcare products Regulatory Agency’s (MHRA) world-leading National Institute for Biological Standards and Control (NIBSC)
in Hertfordshire was the Prime Minister’s chosen launchpad for a new initiative to cement the UK’s position as a science superpower. The exciting plans are set to capitalise on the excellence of UK science throughout the pandemic and beyond, such as that carried out by the NIBSC in relation to COVID-19 vaccine quality control, COVID-19 testing and the essential reference materials to support safe availability of life-saving medicines around the world.
The Prime Minister’s visit today was hosted by the MHRA Chief Executive Dr June Raine and acting Director of the NIBSC Dr Marc Bailey. During his visit, the Prime Minister saw first-hand the pivotal role NIBSC has played in assuring the quality of every single COVID-19 vaccine in the UK
during the pandemic and heard about the vital work being carried out at NIBSC, which has now tested 93 batches of COVID-19 vaccines and certificated over 90 million vaccine doses for use.
Boris Johnson also saw the essential laboratory work which supports NIBSC’s leading global role in helping to determine the final flu vaccine composition each year.
The NIBSC is part of the MHRA and plays a leading role in assuring the quality of biological medicines worldwide, producing over 95% of the World Health Organisation’s biological standards that are used globally.Dr June Raine, MHRA Chief Executive said:
“We were delighted to welcome the Prime Minister today and are pleased to be recognised as a leader in UK science.
“The National Institute for Biological Standards and Control, part of the MHRA, has played a pivotal role in getting safe and effective COVID-19 vaccines to the UK public during this pandemic.
“But our remit goes far beyond the pandemic. We have the largest stem cell bank in the UK, and we play a leading role in helping to assure the quality of thousands of medicines and medical devices worldwide, and in deciding the composition of flu vaccines used each year. These are just a few examples of our ongoing work.
“We look forward to continuing this world-leading work to help cement the UK as a science superpower for the public good.”Prime Minister Boris Johnson said:
“The brilliant scientists and staff at the MHRA have been instrumental in getting our vaccine programme off the ground, transforming lives through science, while ensuring the British people have confidence in the safety of our vaccines.
“It was fantastic to see this work first-hand at the National Institute for Biological Standards and Control and hear more about the impact they have far beyond the pandemic, including in helping protect us against the flu each year.”
Notes to EditorBiological standardisation
Biological medicines such as vaccines are more complex than chemical medicines and so their quality and potency needs to be measured using very specific types of tests. The World Health Organisation provides the gold standard for these tests, against which laboratories around the world compare and calibrate their own tests. This helps ensure that people are getting the same quality of medicines and vaccines world-wide. The NIBSC are a world-leader in this field and produce and distribute 95% of the World Health Organisation’s international standards and reference materials, including those relating to vaccines for COVID-19 and against drug-resistant bacteria. Batch testing
Although vaccine manufacturers carry out their own comprehensive testing regimes on the batches of vaccine they produce, it’s of vital importance that tests focusing on safety and quality are conducted independently, too. In the UK, this independent testing is performed by the NIBSC. Before any batch of COVID vaccine can reach the public, the NIBSC conducts a rigorous assessment to check that it is consistent with characteristics derived from results for batches previously shown to be safe and effective. Influenza
Every year, NIBSC scientists play a key role in helping to determine the final flu vaccine composition. The institute hosts two global conferences on influenza surveillance and identification of candidate influenza strains, and we contribute to decision meetings coordinated by the WHO. NIBSC is one of four global WHO Essential Regulatory Laboratories and produces reference materials for the influenza vaccines that are used internationally Diagnostics
Scientists at the NIBSC produce standard ways of assessing COVID-19 tests for accuracy. NIBSC standards for COVID-19 tests are already being used at NHS testing labs as well as internationally. Sewage testing
Scientists at NIBSC routinely monitor sewage to identify special types of viruses called enteroviruses (such as polio) for the World Health Organisation. They have adapted this technique to monitor COVID-19 in sewage
. Through this technique, NIBSC has been able to detect the alpha (Kent) and delta (Indian) variants. This is exciting, because it shows the tests can provide an “early warning” of troubling variants in the UK without having to test individuals
These findings complement the actions of a separate cross-government project
that has been established to monitor virus levels in sewage across the country.
The Medicines and Healthcare products Regulatory Agency
is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC)
and the Clinical Practice Research Datalink
(CPRD). MHRA is an executive agency of the Department of Health and Social Care.For further information see:Prime Minister sets out plans to realise and maximise the opportunities of scientific and technological breakthroughsThe Prime Minister’s article in the Daily Telegraph: “We’re restoring Britain’s place as a scientific superpower”