Society welcomes COVID-19 vaccine approval (updated 4 June 2021)

Originally published 2 December 2020

On 2 December 2020, the government announced that it accepted the Medicines Healthcare products Regulatory Agency (MHRA) recommendation to approve Pfizer-BioNTech’s COVID-19 vaccine. The approval was the first in the world, for a vaccine that has undergone large-scale clinical trials.

Clinical pharmacologists - including the Society’s President Professor Sir Munir Pirmohamed, and also the Chair of the European Association for Clinical Pharmacology and Therapeutics (EACPT) Professor Jamie Coleman – were closely involved in advising the regulator to ensure the vaccine meets the highest standards of safety and effectiveness.

Professor Clive Page, the Society’s President-Elect, said:

News of regulatory approval for a COVID-19 vaccine is a real moment of hope for a way through the pandemic.
It is a testament to the UK’s long-standing leadership in medicines regulation and safety that the UK was able to prioritise this assessment and progress it so quickly. It’s important to note that in this case, speed was the result of focused and sustained effort in research, development and regulation – no safety shortcuts were taken. As is standard with any new therapeutic, the regulators will continue to monitor the vaccine as it is rolled out in the coming days, weeks and months.
A great number of people and organisations have been involved in getting us to this stage, not least those who took part in trials and enabled this research to happen. Vaccines save millions of lives across the world every year– they are critical for public health. There are still challenges ahead, but vaccinating populations on a global scale is the way we can prevent the loss of life, and way of life, that has been caused by this virus. This news takes us a step closer.

Speaking at the Downing Street briefing on 2 December 2020, the Society's President, Professor Sir Munir Pirmohamed said:

I chaired the Commission on Human Medicines (CHM) expert working group, and first of all I’d like to thank the members of the expert group who worked with me tirelessly with over 40 hours of face-to-face (on zoom at least) committee work and additional reading time. We made recommendations to the Commission on Human Medicines, which then undertook an independent review - and the Commission on Human Medicines is chaired by Professor Stuart Ralston.
We had a wide variety of experts on both groups including people who were experts in viral diseases, immunologists, epidemiologists who look at disease patterns, clinical pharmacologists and toxicologists who are experts in various aspects of medicines. We looked at all sorts of data which was available to us, including raw data - unprecedented access to raw data. This allowed us to look at the overall risk- benefit analysis. We look at risk-benefit analysis for every compound that comes through in terms of licensing and we use the same stringent standards to be able to look at the risk-benefit of this particular vaccine.
We looked at laboratory data, we looked at the manufacturing processes and quality data, as well as the clinical trial data. From this, we came to the conclusion that there was overwhelming benefit for this particular vaccine, and therefore recommended to the MHRA that its use should be authorised.
I just want to say a few things about the effectiveness of this vaccine. The data showed that this vaccine is 95% effective. It is effective in all the groups that were given the vaccine within the trial, irrespective of age, sex, race or country that they lived in. We’ve also looked at the safety of this, the safety of the vaccine is similar to other vaccines. Most of the side effects are very mild and usually last for a day or so. We have been very careful to look at the quality of the vaccine, particularly given the need for storing the vaccine at ultra-low temperatures. We had visits from NHS colleagues to tell us what the deployment strategies were, and we were able to advise them on the stability issues that may be important for deployment. It is important to note that what we have got is data relating to the vaccine up to this point, it is important we undertake surveillance following the use of vaccines in the population.
We were very keen to recommend that the MHRA undertakes active surveillance of the vaccine, after it is used. This includes the use of Yellow Cards as well as a special active monitoring programme, which we will be inviting people to join.
The committee also considered that no specific precautions were required on administrations of this vaccine in people who already had COVID-19. No testing is required before receiving the vaccine.

Sir Munir added:

I think that we are in the midst of a once in a century pandemic. I think this is a historic moment, the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some ways, and this will help save lives.

Update: 4 June 2021

On 4 June 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) approved an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds. This follows a rigorous review of the safety, quality and effectiveness of the vaccine in this age group by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM).

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said:

We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects. There has been a thorough assessment and review of this data which was also looked at specifically by the CHM’s Paediatric Medicines Expert Advisory Group who are scientific experts within this age group, as well as the CHM’s COVID-19 Vaccines Benefit Risk Expert Working Group.

We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk. The MHRA will continue to scrutinise all of the suspected side effects data received through the rigorous surveillance programme in place through the Yellow Card scheme and other safety surveillance measures for all of the COVID-19 vaccines used in the UK.

Over 2000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of COVID-19 from 7 days after the second dose in the vaccinated group, compared with 16 cases in the placebo group. In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.

Read the full story on the Government website.
To find out more about how pharmacology and clinical pharmacology have contributed during the COVID-19 pandemic, please read our recent news story and visit our COVID-19 news hub.

Published: 04 Jun 2021 in Society news