Regulator formally asked to assess Oxford University and AstraZeneca vaccine

Regulator formally asked to assess Oxford University and AstraZeneca vaccine

The UK government has formally asked the medicines regulator to assess the suitability of the Oxford University and AstraZeneca coronavirus vaccine (John Cairns/University of Oxford/PA)

The rollout of a coronavirus vaccine could be a step closer after the UK regulator was formally asked by the British government to assess the Oxford University and AstraZeneca jab.

The move “marks a significant first step in getting the vaccine approved for deployment” if it meets safety, efficacy and quality standards, the UK Department of Health and Social Care (DHSC) said.

It comes a week after the Medicines and Healthcare products Regulatory Agency (MHRA) was formally asked by the UK government to assess the Pfizer/BioNTech vaccine.

British Health Secretary Matt Hancock said: “We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator the MHRA.

(PA Graphics)

“We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards.”

British scientists have defended Oxford University and AstraZeneca after questions were raised about the results of their vaccine trial.

AstraZeneca said it will most likely carry out a further global clinical trial to assess the efficacy of the jab after a surprise result found 90% protection was achieved when people were given a half dose followed by a full dose.

The pharmaceutical giant has acknowledged the finding was as a result of a dosing error, but said it did not expect any new trial to delay regulatory approval in countries including the UK.

US scientists questioned a lack of detail in the trial results published last week, and the scientific head of the US’s Operation Warp Speed – the programme to supply America with vaccines – told US reporters the half-dose regime was only given to people aged 55 and under.

Scientists across the globe are hoping to find vaccines that work in older people – the group who are most at risk from Covid-19.

Helen Fletcher, professor of immunology at London School of Hygiene and Tropical Medicine (LSHTM), said of the Oxford/AstraZeneca vaccine: “It’s not surprising if some manufacturing issues were still being ironed out when they started clinical trials but early stage trials are all about safety and the safety data we have seen has been very robust.”

She said it was important to wait for the full dataset to be published.

Stephen Evans, professor of pharmacoepidemiology at LSHTM, said: “The way the data are put together will have been specified in the protocol and scrutinised very carefully by regulators to ensure that there is no ‘cherry picking’ of the results.”

The DHSC said the MHRA has already started a “rolling review” of the Oxford/AstraZeneca vaccine and that once the regulator receives the full safety, efficacy and quality data from the company, its scientists and clinicians “stand ready to progress its assessment of the vaccine”.

If approved, a vaccine could be rolled out from December, Mr Hancock has said.

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