Modified Covid vaccines for variants could be fast-tracked and approved quickly in UK
The UK could become one of the fastest countries in the world to approve modified Covid vaccines to fight variants.
Vaccine manufacturers including Pfizer and AstraZeneca are already working on new coronavirus jabs to deal with variants in case they are needed.
Once Covid-19 vaccines are adapted, the process for getting them out to the public could be fast-tracked, and the green light could be given in just a few weeks, the Medicines and Healthcare Products Regulatory Agency (MHRA) said.
She said that by carrying out a “real-time” rolling review of evidence, as was done for the existing vaccines, the MHRA’s approval would come “in a very efficient manner, as short as a couple of weeks”.
The regulatory body also said researchers can efficiently measure protectiveness by looking at antibodies in the blood after vaccines, rather than waiting for people in a trial to become infected with Covid-19.
MHRA chief executive Dr June Raine insisted no corners would be cut on safety, and the approach is similar to the regulatory process when flu vaccines are modified to deal with new strains each year.
She said: “Has this approach been done before? This approach that we’re putting out today for the Covid-19 vaccines is based on the tried and tested regulatory process which is used every year for seasonal flu jabs.”
Scientists are concerned that several variants, including the Brazilian one, could make existing Covid vaccines less effective. Six cases of the Brazilian variant have been found in the UK so far - three in England and three in Scotland.
A study this week suggested 25% to 61% of people in the Brazilian city of Manaus - where the variant originated - who had previously had Covid were susceptible to reinfection.
Speaking about whether the UK would be able to get new vaccines out quicker than other countries, she said: “You will be aware that there are other major jurisdictions, the FDA (in the US) and the European Medicines Agency, and this guideline we feel is more flexible and more capable of moving in an agile way, depending on the format of the vaccine, and the data we already hold.
“You’ll be aware that the data we hold in the UK, having been agile initially, is a very substantial set of data.”
During a visit to the Glasgow Lighthouse Lab, Health Secretary Matt Hancock said: “We will have a fast-track approach to safely approving future vaccines that work against a variant of Covid-19.
“The vaccine programme has clearly been a huge UK success story, and part of the reason that we have been able to develop the vaccines so far, so quickly, is because of the MHRA’s rigorous yet flexible approach, which has been based entirely on looking as quickly as possible at the safety and efficacy of vaccines.
“I’m delighted that they’re taking that same principled approach to the approval process for vaccines that may work against variants.”
Guidance from the Access Consortium - a group of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland - states that vaccine manufacturers will need to prove the modified jab produces an immune response, is safe and is of the expected quality.
Data from the original trials and ongoing studies on real-world use of the vaccine could be used to support any decision by the regulators. But lengthy studies would not be needed as they were deemed not to add to the understanding of the jab's safety, quality or effectiveness.
Dr Christian Schneider chief scientific officer at the MHRA, 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 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.”