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UK, 4 Other Regulators To Fast-Track COVID-19 Vaccines Modified For Mutations



Coronavirus vaccines tweaked to deal with variants will be fast-tracked without compromising on safety or effectiveness, the UK’s regulator has said.

The approach will be similar to the regulatory process for the modified flu vaccine, to deal with new strains each year, with a brand 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 vaccines can also be adapted quickly.

The guidance states coronavirus vaccine manufacturers will need to provide robust evidence that the modified shot produces an immune response. However, lengthy clinical studies deemed not to add to the regulatory understanding of their safety, quality or effectiveness will not be needed.

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) said researchers are in a better position to 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 will “significantly reduce” the length of time it takes for the modified vaccine to be ready.

The guidance from the Access Consortium – a group made up of regulatory authorities from the U.K., Australia, Canada, Singapore and Switzerland – 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 real-world use in millions of people could be used to support any decision by the regulators.

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 authorized 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 U.K. 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.”

The news comes days after it was announced that a single dose of the Pfizer-BioNTech vaccine could significantly reduce the risk of transmission of the virus.

A study carried out by Cambridge University found a four-fold decrease in the risk of asymptomatic COVID-19 infection among healthcare workers who had been vaccinated for more than 12 days.

In further good news for the vaccination effort, a study published Tuesday found that both the Pfizer and Oxford-AstraZeneca vaccines are highly effective in reducing COVID-19 infections among older people aged 70 years and over.

Some European countries such as France had previously approved the use of the AstraZeneca vaccine for under-65s only, citing a lack of evidence for older people, but the French health minister announced on Wednesday that older residents could have the jab.

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