MHRA demonstrate flexibility in national application procedure with quick vaccine approval

A high dose Trivalent Influenza Vaccine was granted a UK licence within seven months, compared to the standard twelve month review time for national approvals.

Due to the weaker immune systems in those aged 65+, influenza vaccines have traditionally been less effective in this age group. However, recent advancements in the vaccine technology which improved the vaccines’ effect in people over 65, has led to the Department of Health and Social Care (DHSC) urging that they be made available to the public as soon as possible.

One such trivalent vaccine, which was designed to be effective in the 65+ age group, was approved by the MHRA in a very short time scale, allowing it to be available for uptake in the 2019-2020 flu season.

As this was one of the first vaccines of its kind, the changes had to be evaluated scrupulously to ensure that its safety profile was similar to the existing vaccines. Furthermore there were additional complexities regarding the supply chain due to ever-changing legislation. Nevertheless, as this was a purely national application, it did not require the involvement of other regulatory bodies. Therefore it was possible for the MHRA to be more flexible with the time-frame. It allowed efficient co-operation between the various stakeholders involved with the scientific advice and regulatory aspects.

“It’s exciting to see the MHRA increasingly thinking creatively on how to be a fast, balanced, light-touch yet scientifically robust regulator in order to create and capitalise on opportunities for faster product approvals.”

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