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RPS statement of confidence in the COVID-19 vaccine approval process

The Medicines and Healthcare products Regulatory Agency (MHRA) has now approved a vaccine for use in the UK and more are expected to follow. In light of this the Royal Pharmaceutical Society is today stating its full confidence in the MHRA approval process.

We congratulate the MHRA and pharmaceutical scientists for working collaboratively to turn the discovery and approval of the vaccine around in unprecedented time. A process that would normally take ten years has been completed within a year. This has been the result of global collaboration, unique funding streams and an absolute focus by leading scientists world-wide.

The MHRA’s collaboration with those developing potential vaccines and decision to undertake a ‘rolling review’ approach to its regulatory role in the approval of COVID-19 vaccines is to be commended. Rather than waiting for a final complete submission of evidence, the agency’s proactive approach has meant that data from ongoing studies have been reviewed as and when they become available. This enabled the evaluation of the Pfizer/BioNTech vaccine, as well as other ongoing vaccination candidates, to be completed in as short a timescale as possible.

We are confident that the expert scientists and clinicians at the MHRA have carried out the same rigorous processes as they would for the approval of any other vaccine or medicines. They have also received advice from the Commission on Human Medicines, the UK Government’s independent expert scientific advisory body. Approved COVID-19 vaccines will also be continuously monitored for safety once they are in use. Lessons must be taken from this extraordinary effort for how essential research is conducted in the future. We take real pride in the work of so many of our pharmacists and pharmaceutical science members who have contributed to these efforts.

As trusted and accessible health professionals, pharmacists have a central role in COVID-19 vaccination programmes at strategic and operational levels. Across all sectors, pharmacists will be advising the public and healthcare colleagues on the safety and efficacy of the vaccines; instilling confidence in the process and the vaccine itself. As the professional leadership body, we are also committed to supporting our members to keep up to date on latest developments relating to the vaccine on our COVID-19 vaccines webpage.

As roll out of vaccination begins, the Royal Pharmaceutical Society is calling on all pharmacists to provide leadership in this area and to help inform the public of the safety of MHRA-approved COVID-19 vaccinations. Pharmacists should not advise members of the public against having an approved, evidence-based vaccine except where an individual has an underlying clinical reason. In addition, we encourage all members of the pharmacy team eligible for the COVID-19 vaccine as part of the vaccination programme to take up the offer.

RPS Chief Scientist Professor Gino Martini said:

“The MHRA is world-renowned for its thorough and careful approach to regulation of medicines and vaccines. They have led the approval of many new and complex medicines in recent years which have brought huge benefits to health. As the MHRA have approved the vaccine, I have full confidence that it is safe and that pharmacists should support the MHRA and the vaccination programme now underway."

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