The UK has become the first country in the Western world to approve the roll-out of a vaccine for Covid-19. Developed by the US pharmaceutical giant Pfizer in partnership with the German company BioNTech, the vaccine has gained temporary authorisation for emergency use from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), meaning vaccinations of at-risk groups will begin as soon as next week. The vaccine was deemed safe for distribution, with final approval to follow further data.
The EU’s European Medicines Agency (EMA) is not expected to approve the same vaccine until later in December, giving the UK a slight head-start on its immunisation campaign. The US’s Food and Drug Administration may do the same around 10 December, much to the chagrin of Donald Trump, who reportedly castigated officials when he learned that the UK would administer doses to people not registered on clinical trials before the US.
It is certainly a confidence boost for Boris Johnson’s government, which disregarded the EU Commission’s recommendation that member states wait for approval from the EMA rather than use national regulators. With the UK just a month away from leaving EU institutions such as the single market (and, for that matter, the EMA), the news will likely be used by the UK government to tout the advantages of distance from Brussels regulation.
[See also: Anjana Ahuja on the challenges of vaccine manufacture and distribution]
Yet under EU law, national agencies within Europe are permitted to make emergency authorisations similar to that issued by the MHRA in the UK; EU member states have simply chosen not to, so far. In part, this is a function of the EU’s decision to conduct negotiations for the purchase of vaccine doses with pharmaceutical companies, including Pfizer, as a single bloc. Given that the EU is obtaining vaccines as one unit, a unified policy on approval across member states is the most rational approach. (The UK has opted out of the EU’s joint procurement scheme.)
The EU’s EMA is expected to issue a more thorough “conditional marketing authorisation” after it meets later this month. Such authorisation can be issued in situations “where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required”, according to the EMA’s website.
The UK’s earlier approval of a vaccine may not end up making much difference to its overall roll-out. Pfizer has cautioned that the 40 million doses the UK ordered will be delivered “in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts”. The company does not expect to fulfil its contract with the UK until an unspecified time next year, by which time the vaccine will likely be approved by several more regulators.
A difference of a few weeks between approval by UK, EU and US regulators will, in the face of the vast challenge of manufacturing and administering hundreds of millions of doses, likely prove but a small detail in the long journey to full immunisation.
[See also: Anjana Ahuja on the race for a vaccine]
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