UK could get COVID vaccines early in 2021, ahead of other European countries

The SARS-CoV-2 coronavirus

COVID-19 vaccines could be approved and available early next year in the UK ahead of other European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna.

AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the COVID-19 vaccine it developed in conjunction with Oxford University.

This followed last week’s news that the MHRA has begun a parallel rolling review of a rival from Moderna.

The rolling review allows for a real-time assessment of the clinical data from clinical trials, accelerating a process that normally takes around a year to complete using the centralised European regulatory system.

Using the MHRA could allow the UK to make regulatory decisions on COVID-19 vaccines ahead of the European system, where medicines and vaccines are first reviewed by the CHMP scientific committee before being passed on to the European Commission.

The European Medicines Agency (EMA) has already announced its own fast-track rolling reviews of AZ's vaccine and a rival from Pfizer/BioNTech, although it has not given a timeline for a regulatory decision.

But a source close to the process told pharmaphorum that it is “eminently possible” that the MHRA could reach its conclusions early next year and ahead of its European counterparts as the country reaches the end of the Brexit transition period.

A spokesperson for the MHRA confirmed this is possible and said that from 1st January, it will have new powers to approve medicines, including vaccines with "greater flexibility to do this faster, while maintaining the highest standards of safety, quality and effectiveness."

The spokesperson said: "The MHRA will evaluate the data rigorously on the quality, safety and effectiveness of COVID-19 vaccines to reach a scientifically robust independent opinion if an earlier authorisation is necessary before the EMA authorises a product."

"Patient safety is our top priority. The independent Commission on Human Medicines will advise the UK government on the safety, quality and effectiveness of any potential vaccine. No vaccine will be deployed in the UK unless stringent standards have been met through a comprehensive clinical trial programme"

Representatives of the MHRA used to sit on the CHMP but no longer participate as a result of Brexit, leaving the UK to make its own decisions on medicines regulation should it choose to do so.

According to the source, COVID-19 vaccines could be available in early January depending on the length of time it takes for trial data to be published and shared with regulators.

COVID vaccines are being developed at warp speed, with the development and review process that normally takes up to a decade to complete compressed into less than a year after research began at the end of January.

The MHRA’s approach to the AZ and Moderna vaccines also paves the way for similar fast reviews to rivals from the likes of Pfizer/BioNTech and Novavax, which the UK government also has on order and are reaching the end of the clinical trial process.

The news comes as the country prepares for another national lockdown, which will disrupt business and limit people's freedoms for at least another month.

A vaccine is seen as a potential way out of the cycle of lockdowns that have already caused severe hardship across the UK, which is one of the countries worst hit by COVID-19.

An AstraZeneca spokesperson told pharmaphorum: “Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. It is then up to the regulatory bodies to review and make approval decisions based on this data, as quickly as possible.

“The EMA announced in October that its CHMP had started a ‘rolling review’ of data for AZD1222, the first COVID-19 vaccine to be evaluated under these arrangements. We confirm the MHRA’s rolling review of our potential COVID-19 vaccine.”