UK asks regulator to approve Oxford-AstraZeneca vaccine

The UK government said on Friday that it has formally asked the country's independent medicines regulator to 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 UK will be one of the first countries in the world to receive the vaccine, if authorised, with pharmaceutical major AstraZeneca expecting to have up to 4 million doses ready for the country by the end of the year and 40 million by the end of March 2021, the government said.

The move to formally seek approval follows the vaccine team declaring its efficacy in trials earlier this week. However, there have been some concerns raised around the way the results were collated.

"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," said UK Health Secretary Matt Hancock, in reference to a formal letter to the Medicines and Healthcare products Regulatory Agency’s (MHRA).

Also read: Covid-19: AstraZeneca working with regulators on best approach to lower dose regimen

The MHRA is the UK's independent regulator and has already been tasked with reviewing data from Pfizer/BioNTech to determine whether its Covid-19 vaccine meets "robust" standards of quality, safety, and effectiveness.

On Monday, the University of Oxford and AstraZeneca published their interim efficacy results, which indicated the vaccine was at least 70 per cent effective in protecting individuals from Covid-19. This rose to 90 per cent effective when administered as half a dose, followed by a full dose – rather than two full doses.

The UK government's Department of Health and Social Care (DHSC) said that 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 stand ready to progress its assessment of the vaccine.

Until the end of December, and as part of the Brexit 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 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, asks MHRA Chief Executive Dr June Raine for the regulator to evaluate whether the vaccine can be authorised under this regulation.

The DHSC said the UK was the first country in the world to sign an agreement with Oxford University/AstraZeneca, securing access to 100 million doses of the vaccine.

The UK's Joint Committee on Vaccination and Immunisation (JCVI) has been advising the government on which vaccines the UK should use and provide advice on who should be offered the vaccination first.

The DHSC said the committee's interim advice is that a Covid-19 vaccine should first be given to care home residents and staff, followed by people over 80 and health and social workers, then to the rest of the population in order of age and risk.

Vaccination will be managed by the health services in each of the four UK nations: NHS England and NHS Improvement, NHS Wales, NHS Scotland, and Health and Social Care Northern Ireland.

Through the Vaccines Taskforce, the UK government says it has secured early access to 355 million doses of seven of the most promising vaccine candidates, including Pfizer/BioNTech for 40 million doses; Oxford/AstraZeneca for 100 million doses; Moderna for 5 million doses; GlaxoSmithKline and Sanofi Pasteur for 60 million doses; Novavax for 60 million doses; Janssen for 30 million doses; and Valneva for 60 million doses.