New trial data reassures Oxford vaccine efficacy, MHRA says

The Medicines and Healthcare products Regulatory Agency (MHRA) has obtained additional trial data from AstraZeneca that supports their view that the Covid-19 vaccine developed with Oxford University is effective in the elderly, an official from medicines regulator has said on Friday (Feb 5).

Munir Pirmohamed, Chair of the Commission on Human Medicines' Covid-19 Vaccines Benefit Risk Expert Working Group said regulators had noticed the smaller number of under-65s in the data when they approved the vaccine.

"Nevertheless, there was no evidence (to suggest) that those people over 65 were not getting evidence of efficacy," he said at an MHRA news briefing.

"Since then we've seen more data coming through from AstraZeneca as more people are completing the trial, which highlights again that efficacy in the elderly is seen, and there's no evidence of lack of efficacy."

He added elderly people were generating strong immune responses, and said that the most important thing was that both AstraZeneca's vaccine and a shot developed by Pfizer and BioNTech were preventing serious disease and deaths.

Over 10 million doses of the Pfizer/BioNTech and the Oxford University/AstraZeneca vaccines have been administered across the UK and the MHRA has gathered a large amount of safety data, which the regulator published on Friday.

This data showed 22,820 reports of suspected side effects, or an overall reporting rate of three in 1,000 doses of vaccine administered from December 9, 2020 to January 24, 2021.

“This reassuring data has shown that the vast majority of reported side effects are mild and all are in line with most types of vaccine, including the seasonal flu vaccine. These include sore arms and mild ‘flu-like’ symptoms, which reflect a normal immune response to vaccines and are short-lasting,” the MHRA said.

Dr June Raine, MHRA Chief Executive, said: “The data we have collected provides further reassurance that the Covid-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain confident that the benefits of these vaccines outweigh any risks.

“Our priority is to ensure the public have safe and effective vaccines and we will continue to analyse, monitor and review all the safety data for these vaccines.”