Vaccines against Covid-19 variants to be fast-tracked for approval, MHRA says

4 March 2021, 08:36

Modification to Covid-19 vaccines to combat variants will be fast-tracked
Modification to Covid-19 vaccines to combat variants will be fast-tracked. Picture: PA Images
Ewan Quayle

By Ewan Quayle

Vaccines modified to combat Covid-19 variants in the future will be fast-tracked for approval, the medicines regulator has announced.

The Medicines and Healthcare products Regulatory Agency (MHRA) said on Monday it would allow modifications that respond to new variants of coronavirus to be made available quickly to UK recipients.

The body said it would approve new drugs "without compromising on safety, quality or effectiveness" but that "lengthy" clinical studies into modifications of already approved drugs would not be needed.

Read more: Covid infection decline slows amid fears people will get ill before vaccine

Read more: Teen with no known underlying health conditions among latest Covid deaths

The decision, which will significantly reduce the length of time taken for the modified vaccine to be ready for use, was jointly agreed earlier this week by the  ACCESS Consortium – a coalition of medical regulators from the UK, Australia, Canada, Singapore and Switzerland.

New guidance from the group sets out what information regulators would need to approve any modifications, should any virus mutations make them less effective at preventing the disease.

'Govt absolutely did not do enough to prevent Brazil Covid strain'

It says that vaccine manufacturers would need to provide significant evidence that a modified drug produces an immune response, but that major clinical studies involving thousands of participants would not be necessary,

The regulator said there would be no point in launching trials as researchers are now better able to measure protection by looking at antibodies in the blood following vaccination, reducing the need to wait and see whether or not people become infected with the disease.

Explained: Key points from Budget 2021

Read more: Health officials exploring 'cash for exercise' to tackle obesity epidemic

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 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."

Dolly Parton gets shot of Moderna vaccine that she helped fund

But alongside data on the immune response, the vaccine manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality.

The guidance says data from original trials and the ongoing studies on real-world use in millions of people could be used to support any decision by the regulators. 

This approach is based on the tried and tested regulatory process used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year.

Read more: Search for missing Brazil Covid variant case narrowed down to 379 households

It comes as a new 'variant of concern' first discovered in Manaus, Brazil was confirmed to have entered the UK for the first time last week.

Up to six cases have been identified in England and Scotland so far, including a mystery case whose whereabouts is unknown, prompting a frantic search by health officials to find them and order them to self-isolate.

Public Health England and Test and Trace officials are continuing to track the case down, with the searched narrowed on Tuesday to just 379 households in the South East of England.

More Latest News

See more More Latest News

Israel Palestinians Britain Aid

UN top court orders Israel to open more land crossings into Gaza

Music-Green Day UN

Green Day to headline UN-backed global climate concert

Exclusive
Starmer has vowed to resurrect Boris Johnson's 'Levelling Up' policy

Failure to ‘level up’ Britain would be ‘catastrophic’, Wes Streeting admits, as Starmer vows to resurrect Johnson policy

Border Force staff will walk out from April 11

Hundreds of Border Force officers at Heathrow Airport to stage four-day strike

Stephen Bear was ordered to pay Ms Harrison £5,000.

Disgraced reality TV star Stephen Bear ordered to pay £27,000 over revenge porn conviction or face nine months in jail

Sam Bankman-Fried

FTX founder Bankman-Fried sentenced to 25 years in prison for crypto fraud

Exclusive
Covid no excuse for death of Finley Boden who was murdered by drug-addled parents, child protection chief says

Covid no excuse for death of Finley Boden who was murdered by drug-addled parents, child protection chief says

Israel Palestinians UN Security Council

Russia ‘abolishes’ monitoring of sanctions on North Korea with UN veto

France Valentino

Former Gucci designer Alessandro Michele named Valentino creative director

Know your limits this summer, Brits have been warned

‘Know your limits’: Brits heading to the Euros this summer warned against drinking ‘too much German beer’

Russia Shooting

Russia arrests another suspect in concert hall attack that killed 143

Sam Bankman-Fried has been jailed for 25 years for a $8bn crypto fraud

'Crypto King' Sam Bankman-Fried jailed for 25 years for stealing billions of dollars from his customers

Michael Gove has been urged to 'get on with' passing the rental reforms

Ministers accused of making 'major concessions to landlords' after renters reforms 'watered down'

Supermarket opening times for Easter 2024: Trading hour revealed for Sainsbury's, Asda, Tesco, Morrisons and Aldi

Supermarket opening times for Easter 2024: Trading hours revealed for Sainsbury's, Asda, Tesco, Morrisons and Aldi

It is believed the litter picking tool was mistaken for a firearm, Northumbria Police said

Schools locked down by police after litter picker mistaken for firearm

Lewes prison

Medical incident declared at Lewes prison after several inmates hospitalised with food poisoning