Covid-19 vaccines that have been modified to better protect against virus variants will be fast-tracked for approval just like flu vaccines, regulators have said.
Guidance on approving modified vaccines put together by a group of regulators including the UK Medicines and Healthcare Products Regulatory Agency (MHRA) say that approved Covid-19 vaccines that have been altered to tackle variants will not need to undergo ‘lengthy’ clinical studies.
The ACCESS Consortium said manufacturers would not be starting the approval process from scratch but they would need to provide robust evidence that the vaccines trigger an antibody response.
They would also need to provide evidence that they modified vaccine is safe and is of the expected quality but regulators would also make use of ongoing studies of real-world use of Covid-19 vaccines to support the approvals process, the Consortium said.
It is based on the approach already used for seasonal flu vaccines where annual modifications are made, the group of regulators from the UK, Australia, Canada, Singapore and Switzerland confirmed.
The UK was the first country to approve the Pfizer/BioNTech vaccine at the start of December 2020 after a rolling review of the evidence from clinical trials. The Oxford/AstraZeneca vaccine was approved at the end of that month.
The MHRA said there was no evidence at the moment that any of the current vaccines in use were lacking in effectiveness against variants in circulation but they were prepared if that happened.
Researchers are already working on updating vaccines should a booster be needed. The fast track regulation process would mean approval could be done in a matter of weeks.
MHRA chief scientific officer, Dr Christian 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.’
GPs could be administering Covid variant booster shots ‘later this year’ if new strains make this necessary, as the UK Government has placed an order for an initial 50 million doses of modified vaccines.