MHRA head June Raine lauds ‘flexibility and agility’ of UK researchers
The chief executive of the UK’s medical regulator has defended the country’s rapid approval of a Pfizer vaccine for Covid-19, and praised the researchers working for her.
Last week the UK became the first country in the world to approve the vaccine developed by Pfizer and BioNTech, with the first people receiving the approved jab just days later on 8 December. The speed of the regulator’s move led to criticism from some officials and researchers overseas.
But, appearing before a House of Commons select committee hearing on 9 December, Medical and Health Products Regulatory Agency (MHRA) head June Raine insisted that the “highest standards of safety, effectiveness and quality” had been met.
“Normally all the data on a vaccine safety, quality and effectiveness and all required documentation must be submitted together to start an evaluation to approve a medicine or a vaccine,” she explained.
Instead, for this vaccine the MHRA undertook a ‘rolling review’, and looked at data in packages as soon as they became available from ongoing studies.
“By reviewing data as soon as it became available, we could reach an opinion sooner on whether the medicine or the vaccine would be approved,” she said.
While other countries such as the United States have also adopted this approach, Raine said the “flexibility and agility of the clinicians and scientists at the MHRA, coupled with their familiarity with vaccine development and approval and the access to independent expert advice, was key to our ability to progress in the shortest time”.
Asked when the MHRA would be able to complete its approval process of another Covid-19 vaccine being developed by the University of Oxford and AstraZeneca, Raine said the agency had received data packages from the developers and expected a further package “in the coming days”.
As for a third vaccine from Moderna, Raine said the MHRA was engaged in a rolling review with developers and expected a more data in the next week or two.
‘Too soon to lift restrictions’
Despite the MHRA’s vaccine approval, the government’s chief medical officer Chris Whitty told the same hearing it would be wrong to lift restrictions at the moment, comparing it to “someone giving up a marathon race at mile 16”.
The government’s chief scientific adviser Patrick Vallance agreed that the biggest risk now was that people would think the pandemic was all over.
“We have a very important light at the end of the tunnel, but we’re a long way off,” he told MPs. “It’s not the time to relax things. If that happens we will have a big surge.”
He said any lifting of lockdown restrictions would be a “science-informed political decision”. “But, ultimately, then there are some decisions to be made about how much risk society wishes to take.”