Amid test data doubts, UK seeks temporary supply of AstraZeneca/Oxford vaccine
The Boris Johnson government has requested the UK’s 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, amid doubts regarding its trial results.
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 by the end of the year and 40mn by the end of March 2021, the Department of Health and Social Care said in a release.
The UK was the first country in the world to sign an agreement with Oxford University/AstraZeneca, securing access to 100 mn doses of the vaccine, it added.
The Medicines and Healthcare products Regulatory Agency (MHRA) confirmed the government request and said public safety “will always come first.”
Health secretary Matt Hancock said: “We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards. This letter is an important step towards deploying a vaccine as quickly as safely possible”.
The letter asks MHRA 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 team of scientists and clinicians will progress its assessment.
The UK government has already formally asked the MHRA to assess the Pfizer/BioNTech vaccine for its suitability for authorisation under Regulation 174.
The UK has so far secured early access to 355mn doses of seven of the most promising vaccine candidates, including: Pfizer/BioNTech (for 40mn doses), Oxford/AstraZeneca (100mn), Moderna (5mn), GlaxoSmithKline and Sanofi Pasteur (60mn), Novavax (60mn), Janssen (30mn) and Valneva (60mn).
Johnson on Thursday evening sounded a note of caution on relaxations announced for Christmas, asking Britons to follow guidelines strictly to prevent another spike in new cases and potentially another lockdown in early 2021. The current lockdown in England is to end on December 2, with the country moving to the earlier 3-tier alert system.