Today the Pfizer/BioNTech COVID-19 vaccine has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
The UK's medicines regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe to be rolled out. The UK has already ordered 40 million doses of the jab - enough to vaccinate 20 million people.
The Secretary of State for Health said that the NHS will contact people about jabs. Elderly people in care homes and care home staff have been placed top of the priority list, followed by over-80s and health and care staff. But because hospitals already have the facilities to store the vaccine at -70C, as required, the very first vaccinations are likely to take place there - for care home staff, NHS staff and patients - so none of the vaccine is wasted.
James said: “It is great news that the UK is the first country in the world to have a clinically approved vaccine for supply and I pay tribute to all those involved in making this happen. This positive development is part of getting life back to normal however it will take time to roll out this, and hopefully other vaccines, so it is essential that we all continue to follow the rules to help keep the virus under control.”
The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Since October 2020 a dedicated team of MHRA scientists and clinicians have carried out a rigorous, scientific and detailed review of all the available data.
The review followed a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
The National Institute for Biological Standards and Control will continue to run independent laboratory tests so that every batch of the vaccine meets the expected standards of safety and quality.
The government has now secured 357 million vaccine doses from 7 different developers, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible.
In October the government changed the regulations so that during the transition period (which ends on 31 December 2020) new vaccines could be approved for the UK without waiting for approval by the EU. Today there are media reports that the EU process is delayed and EU countries will have to wait until next year to begin vaccinations.
