UK will diverge from EU and US on approving tweaked Covid vaccines
The UK will adopt a different standard from Europe and the US when it considers approval for coronavirus vaccines that have been tweaked to deal with variants, the regulator has said.
There would be no compromise on safety or effectiveness, said Dr June Raine, head of the Medicines and Healthcare products Regulatory Agency. But the UK will not insist, as the European and US regulators do, that the tweaked vaccine must be “non-inferior” to the original.
The UK has left the European Medicines Agency (EMA) post-Brexit. It used an existing provision before leaving to give the Oxford/AstraZeneca vaccine emergency authorisation ahead of the rest of the world in December.
It has now joined the Access consortium of regulators from Australia, Canada, Singapore and Switzerland, with whom it has published guidance on how tweaked vaccines will be approved for use.
“What I would like to say is we closely liaise with EMA and the FDA, though I stress, too, that the Access consortium is our partnership organisation at international level,” said Raine at a briefing on the new guidance.
“The hallmark of our guidance is scientific flexibility. That’s not a contraction in terms. It’s that we will use the best possible science and integrate sources of data commensurate with the urgency of the situation and so our flexible guideline is what we believe will enable us to adapt very quickly to a changing situation, which as we know can change very fast.”
The approval process would not necessarily be faster, said Dr Christian Schneider, the MHRA’s chief scientific officer. “It could be. But the main difference is the so-called clinical non-inferiority for immunogenicity.
“It basically means the EMA and the FDA [Food and Drug Administration in the US] are requesting that a new version of the vaccine is in no way inferior to the previous version when it comes to an immune response.”
The practical problem with that, he said, was not knowing where the threshold was. “When do you say that a new version is actually inferior to the previous? It is an arbitrary margin and it may well be that a vaccine is still efficacious even if is formally not hitting that margin,” said Schneider.
“This is why we say we look at the immune response per se, but we’re doing this with other data that we see, for example cellular immune response, cross-reactivity and so on. Then we will make a decision based on that. That enables us to look at this more on an individual basis and regulate this in a scientifically sound manner.”
Raine said the approach would be similar to the regulatory process for the flu vaccine, which is modified to deal with new strains each year, with a full new approval not required.
Scientists have previously said a Covid-19 variant resistant to the current crop of vaccines is likely to emerge at some point, but the manufacturers are already working on tweaks to those vaccines. Oxford University has said these could be in trials in June. New versions are expected to be ready in the autumn, if they get approval, which Raine and Schneider said might take only a couple of weeks or less.
The guidance states coronavirus vaccine manufacturers will need to provide robust evidence that the modified jab produces an immune response. However, lengthy clinical studies are deemed not to add to the regulatory understanding of their safety, quality or effectiveness and will not be needed.
Researchers will measure protection by looking at antibodies in the blood after vaccination, reducing the need to wait and see whether people in a trial become infected with the virus.
It said this would “significantly reduce” the length of time it took for the modified vaccine vaccines to be ready.
The health secretary, Matt Hancock, expressed confidence in the vaccines on a trip to Glasgow.
Asked if his visit was making a political point about the importance of the union to the success of the vaccine programme, Hancock said: “Now is not the time for any of these constitutional arguments,” but added: “There’s absolutely no doubt that the strength of the UK working together means we can go as fast as we can on the vaccine programme.”
While Nicola Sturgeon has spoken recently about the impact of crossborder travel on the spread of new variants, Hancock said that – while it was important to remain vigilant about the emergence of new variants – he was optimistic that people would be able to travel across the four nations by the summertime.
“I am more optimistic about having a Great British summer than I have been at any time thanks to the speed and the effectiveness of the vaccine rollout, and by that I absolutely mean people being able to enjoy travel across the whole of the UK. Of course the travel rules for Scotland are a matter for the Scottish government, but we can all see that we can make strides down that roadmap thanks to the speed of the vaccine rollout.” he said.
The guidance from the Access consortium requires that, as well as evidence on immune response, the modified vaccines must be shown to be safe and of the expected quality.
It says data from the original clinical trials and ongoing studies on realworld use in millions of people could be used to support any decision by the regulators.
Schneider said: “Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety. Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”
Meanwhile, research has suggested the rate of decline in Covid-19 infections in England has slowed, with data indicating that in some parts of the country the rate has plateaued while in some places there are hints that rates are increasing.
One in every 213 people is still testing positive for Covid-19, the Imperial College London React study found.
Researchers warned that infection rates needed to get as low as possible to give the vaccination programme the best chance of working.
The study also suggested that some professions have had higher rates of infection than others during the national lockdown, including teachers and transport workers.
The latest government data – up to 2 March – shows that 20,703,615 first doses of vaccine have been administered so far in the UK.