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The development of coronavirus vaccines tweaked to target new variants will be fast-tracked in the UK and four other countries, Britain’s regulator has said, adding that “robust evidence” on effectiveness and safety will still be required for authorisation.
The approach, similar to the regulatory process for the modified flu vaccine, will not need a brand new approval or “lengthy” clinical studies, the Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday.
This will “significantly reduce” the length of time it takes for the vaccines to be ready, with concern mounting over the threat posed by the South African and Brazilian variants and their ability to partially evade the body’s immune response.
Under the new guidance, developers will need to provide clear evidence their adapted vaccines produce a strong immune response to the variant and meet the high safety standards outlined by the MHRA.
“This is based on scientific principles and does not cut any corners on safety or effectiveness,” said Dr Christian Schneider, chief scientific officer at the MHRA.
Regulators in Australia, Canada, Singapore and Switzerland are implementing the same measures for their vaccine rollouts, as part of an international partnership called the Access Consortium.
Data from the original clinical trials and ongoing studies on real-world use in millions of people will be shared among the group to support any regulatory decision that is made.
MHRA said it hopes this partnership will accelerate the regulatory process, enabling the different parties to become more “agile” in reviewing and approving the modified vaccines.
Dr Schneider explained that “if every regulator had their own requirements then it would take companies much longer to fulfil all of them. This is why we’re very glad we were able to harmonise our requirements with major international regulators.”
For manufacturers modifying their jabs, Dr Schneider said the MHRA and other regulators were recommending a small clinical trial – similar to the phase two stage of testing, which typically involves 100s of participants – which is “sufficient to assess” the expression of any adverse effects from the vaccine.
The ability of the modified vaccine to generate an immune response will be measured by assessing the antibody levels of those who receive the jab.
“A trial based on the spontaneous occurrences of infections with the coronavirus would take too long and we already know that the vaccine format works,” Dr Schneider said.
“It’s a bit like when you put a new engine into a car. The crash tests will still be the same, the car will still drive, but you make a small comparison with the previous version in order to be sure.”
He added: “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 announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can help ensure faster access to life-saving vaccines in the UK and around the world.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”
MHRA chief executive Dr June Raine said vaccine modifications will follow a similar authorisation process seen with the development of annual flu jabs, which are tailored to target new variants.
“Of course there will be checks on manufacture, on safety, on quality, but we will be using the approach that’s been very successful for flu jabs,” she said.
“Every year there’s a tried and tested regulatory process for the seasonal flu vaccines so that they match the strains circulating each year.”
The announcement comes amid mounting concerns and evidence that the Brazilian variant, known as P1, may be more resistant to existing vaccines than other mutated forms for the virus.
The UK has banned direct flights from 33 countries in an effort to prevent variants of concern from becoming established across the four nations.
However, Dr Raine said there is no current evidence that suggests the vaccines deployed in the UK won’t be able to protect against the known coronavirus variants.
“Since December last year we have all been concerned about the appearance of variants – Kent, South Africa, more recently Brazil – and therefore we’re well-prepared to look at, when it’s needed, updates to ensure the vaccines being used in citizens are fully effective,” she added.