The government has formally asked the Medicines and Healthcare products Regulatory Agency to evaluate whether supply of Oxford/AstraZeneca vaccine can be authorised.
The government has formally requested the UK’s independent medicines regulator assess the suitability of Oxford/AstraZeneca’s COVID-19 vaccine for temporary supply, as soon as the company submits the necessary safety, quality and efficacy data.
The move marks a significant first step in getting the vaccine approved for deployment, should it meet the regulator’s requirements.
The UK will be one of the first countries in the world to receive the vaccine, if authorised, with AstraZeneca expecting to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March 2021.
The UK is the first country in the world to sign an agreement with Oxford University/AstraZeneca, securing access to 100 million doses of the vaccine.
Earlier this week, the University of Oxford and AstraZeneca published their interim efficacy results, which indicated the vaccine was at least 70% effective in protecting individuals from COVID-19.
This rose to 90% effective when administered as half a dose, followed by a full dose – rather than 2 full doses.
Health and Social Care Secretary Matt Hancock said:
In a letter sent by the Department of Health and Social Care to the Medicines and Healthcare products Regulatory Agency (MHRA), the government has asked the regulator to assess the vaccine for authorisation under Regulation 174 of the Human Medicines Regulations, which enables the temporary supply of medicines to be authorised in response to a public health need.
The MHRA has already started a rolling review to determine whether the Oxford/AstraZeneca vaccine meets its strict standards of safety, efficacy and quality.
Once the MHRA receives the full data from the company, its renowned team of scientists and clinicians stand ready to progress its assessment of the vaccine.
Until the end of December, and as part of the transition period, vaccines must be authorised via the European Medicines Agency and that authorisation will automatically be valid in the UK.
However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented – Regulation 174 – allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.
The letter, signed by Deputy Chief Medical Officer for England Professor Jonathan Van-Tam and Director for COVID-19 Vaccine Deployment Antonia Williams, requests the MHRA’s Chief Executive Dr June Raine for the MHRA to evaluate whether the vaccine can be authorised under this regulation.
The government has already formally asked the MHRA to assess the Pfizer/BioNTech vaccine for its suitability for authorisation under Regulation 174.
Until a vaccine is approved, the public must continue to take necessary actions to keep themselves and their loved ones safe including by following the ‘Hands. Face. Space’ guidance and other public health advice.