Brexit's Last Gasp Throws a Spanner into the First COVID Vaccine Approvals

It is a curious coincidence that just as Britain is teetering on the edge of an acrimonious and unceremonious separation from the EU, a stand-off should also have developed in the normally sedate world of medicines regulation, pitting the UK's Medicines and Healthcare products Regulatory Agency against the European Medicines Agency and the European Commission just as the first vaccines become available against the COVID pandemic that has disfigured most of 2020.

But such is the case—bizarrely converting into an unseemly squabble over authorization procedures a moment that should have been, in respect of vaccines at least, a cause for global celebration at the prospect of deliverance from suffering. The facts are now well-known: on November 23^rd, Pfizer/BioNTech made their final data submission to MHRA for their candidate product. On December 1^st, they applied for EU approval via EMA. On December 2^nd, MHRA gave an approval to the Pfizer/BioNTech vaccine—the first in the world, prompting questions about how the UK had been so quick, or why the EU (and indeed the FDA) had been so slow.

For the best part of a week now, Europe has been the scene of claim and counter-claim about the merits of distinct regulatory approaches, and even some inaccurate and ill-informed comments from senior UK government figures that Brexit had been a factor in the UK victory in the race to approve a COVID vaccine. On December 7^th, MHRA CEO June Raine poured fuel onto the blaze by provocatively crowing in The Times of London that her team had "backed a jab before the rest of the West."

The reality is, as might be expected, a little more complicated. The UK approval relates only to temporary supply in a public health emergency. And as the evidently piqued EU authorities have been at pains to point out, this is quite different (and they imply, quite inferior) to the conditional marketing authorization procedure now underway through EMA for the Pfizer/BioNTech product. Lengthy EU briefings have detailed the advantages of this approach, underlining how a conditional marketing authorization "provides a robust framework for accelerated approval" with accompanying safeguards and controls for risk management and safety monitoring, with legally binding requirements on companies covering aspects such as reporting on further trials, batch controls, conditions for storage or investigation plans for use in children. In contrast, "the legislation which is used for temporary use of unauthorized medicines does not in itself provide any particular requirement for evidence to be presented in support, or for conditions to be applied for followed up by the manufacturer," an EMA official said. The underlying message is that short cuts could damage public confidence in any vaccine.

Raine has fought back against any suggestion of laxity predominating over speed in assessing the vaccine. In a defense littered with rhetorical invocations of "scaling peaks", "working around the clock," and leaving "no stone unturned," she insists MHRA experts "pored over pages of data" and "reviewed it with rigor". "I can assure you without reservation that the standards we have worked to are equivalent to those around the world—no corners have been cut," she concluded her comment in The Times.

But this one will run and run. On December 10^th, the new executive director of EMA, Emer Cooke, will appear before the European Parliament's health committee to answer questions about the authorization process and the progress with the applications received so far—from Pfizer/BioNTech and Moderna. She will doubtless repeat the line that the EU has been promoting recently, that the assessment of the candidates will be accelerated, and a first opinion on the marketing authorizations could be issued "within weeks," with a recommendation for the first vaccine by December 29^th "at the latest." And on December 11^th, EMA will host a conference on its authorization processes, open to all, to explain its actions and invite comment from stakeholders.

The rivalries will doubtless be intensified from December 31^st, when the transition period linking the UK to the EU finally comes to an end—four-and-a-half years after the UK vote for Brexit. The MHRA decision on the Pfizer/BioNTech vaccine, while made independently, was made in compliance with the EU rules that continue to apply until the end of this year, under a specific provision for emergency use. But as Raine says, almost defiantly, "Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorization for use in Great Britain and will instead be assessed directly by the MHRA." The inelegant contest, for such it is turning into, has hardly begun.