The UK has become the first western country to issue regulatory approval for a coronavirus vaccine and is preparing to vaccinate people with the BioNTech/Pfizer shot next week, ahead of the EU and the US.
How was the UK able to give approval so quickly?
The UK approved the vaccine before the EU using regulation 174 of the UK’s Human Medicines Regulations, which enables the temporary authorisation of a medicine prior to approval by the European Medicines Agency in the case of urgent public need.
Since October, when the first data from the BioNTech/Pfizer trial became available, scientists and clinicians at the UK Medicines and Healthcare products Regulatory Agency, or MHRA, had “worked round the clock” to review more than 1,000 pages of information, according to June Raine, the agency’s chief executive.
Normally each stage of a clinical trial must be completed before the next stage begins, but the BioNTech/Pfizer trial had been adapted by the companies to allow the different trial stages to “overlap”, Ms Raine said. The MHRA then undertook a rolling review of the data, she said, to allow for the assessment of the vaccine “in the shortest time possible”.
Was the UK able to do this because of Brexit?
No. The UK remains under the authority of the EU’s European Medicines Agency until the end of the Brexit transition on December 31 and the regulation the UK used to diverge from the EMA predates the Brexit vote. A similar provision exists under EU law. It allows member states to “temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm”. Any EU country could use that opt-out to approve a Covid-19 vaccine.
Brexit has, however, given the UK more political freedom to act. The vaccine strategy for the EU’s remaining 27 members is overseen by the European Commission, which has negotiated vaccine contracts with drugs companies to supply all participating nations. The UK had the opportunity to participate in the EU’s vaccine programme, but chose not to.
Why is the EU taking longer?
The EMA says the “conditional marketing authorisation” it plans to grant requires more evidence than the emergency use authorisation issued by London. Conditional marketing authorisation requires “extensive” data and is the “most appropriate regulatory mechanism” to underpin mass vaccination campaigns, the agency says.
The UK denies that safety has been sacrificed for speed in its approval process. “No corners have been cut, none at all,” the MHRA’s Dr Raine said on Wednesday.
The EMA plans to issue a decision on the BioNTech/Pfizer vaccine at a meeting on December 29, at the latest.
Are other EU countries likely to follow the UK?
For now, there is no sign of a revolt. Such a rupture would put national governments on a collision course with the commission and the EMA. If the EU authorisation is on track to arrive just a few weeks later than the UK’s, it is unlikely to make national governments want to take the risk.
But Brussels has had to work hard to manage expectations. Last month it warned against the activation of the emergency use authorisation just deployed by the UK, amid concerns that Hungary would exploit it to fast-track Russia’s Sputnik V vaccine without full safety data.
Additional reporting Donato Paolo Mancini in London
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