Freedom of Information request on the yellow card reports from the COVID-19 vaccines (FOI 21/933)
Published 20 January 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-23-august-2021/freedom-of-information-request-on-the-yellow-card-reports-from-the-covid-19-vaccines-foi-21933
25th August 2021
FOI 21/933
Dear
Thank you for your email.
The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs).
Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness. As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for these new vaccines, tens of millions of doses of which have been given and for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.
Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.
Other sources are also used to help assess if a vaccine is likely to have caused a medical event. Particularly for COVID-19 vaccines, additional sources of information include data analysis on national vaccine usage, anonymised GP-based electronic healthcare records, and other healthcare data to proactively monitor safety. We also take into account the international experience based on data from other countries using the same vaccines. Evaluating multiple data sources helps consolidate any findings from our signal detection processes; it strengthens our evidence if regulatory action is required for a newly identified safety issue or side effect.
As mentioned, numerous measures are undertaken to assess suspected vaccine-induced adverse events. We work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.
Regarding your questions about vaccination of adolescents, please note that the Joint Committee on Vaccination and Immunisation is the body responsible for making recommendations on vaccination policy, such as vaccination of adolescents. However, we have carefully reviewed clinical trial data for the Pfizer/BioNTech vaccine in over 2000 children aged 12 to 15 years of age and have concluded that that the benefits of this vaccine outweigh any risk and that it is effective and acceptably safe in this age group. This data has also been reviewed by the independent Commission on Human Medicines (CHM), its COVID-19 vaccine benefit-risk expert working group, as well as the Paediatric Medicines Expert Advisory Group.
No new side effects were identified and the safety data in children was comparable with that seen in young adults. As in the young adult age group, the majority of adverse events were mild to moderate, relating to reactogenicity (e.g. sore arm and tiredness.)
The Commission on Human Medicines (CHM) met on 27 May 2021 to discuss the request to vary the existing authorisation to extend the approval to apply to children aged 12 – 15 years old.
The CHM considered the results of randomised, placebo-controlled clinical trials in over 2000 children aged 12 – 15 years.
The immunogenicity results (showing how well the vaccine works), studied in approximately 200 children, demonstrated similar neutralising antibody levels in adolescents aged 12-15 years compared with the levels in young adults aged 16-25 years.
These results are supported by a very high level of short-term efficacy data in adolescents against symptomatic disease after 2 doses of vaccine 21 days apart.
In participants with no prior evidence of infection there were no cases of COVID-19 in the vaccinated group from 7 days after the second dose compared with 16 cases in the placebo group.
Consistent with what was seen in adults there was evidence that the vaccine provides protection even before the administration of dose 2. There were no cases seen in the vaccine group from 11 days after dose 1 compared to 31 in the placebo group. Prior to day 11 there were 3 cases in the vaccine group and 4 on placebo.
Safety data in children aged 12-15 years is available from one clinical trial. This safety data is supported by the safety data from the clinical trials in individuals aged 16 years and over, together with a large amount of real-world data on the safety of the Pfizer/BioNTech COVID-19 vaccine. This has been closely monitored as the vaccine has been rolled out both in the UK and internationally. This experience has reinforced the conclusion that the benefits of the Pfizer/BioNtech COVID-19 vaccine continue to outweigh any possible side effects.
The MHRA’s assessment of the use of the Pfizer/BioNTech vaccine in adolescents is available in Annex 1 of the below-linked Public Assessment Report (PAR):
Furthermore, the study of the safety, immunogenicity, and efficacy of the Pfizer/BioNTech vaccine is published in a peer-reviewed journal, the link to this is also provided below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2107456
You may be interested to know that other regulatory authorities around the world, including the European Medicines Agency (EMA), US FDA and Health Canada, have also approved the use of the vaccine in 12 – 15 year olds. Nearly 5 million 12 – 15 year olds in the USA have now received the vaccine, of whom 3.5 million have received both doses CDC COVID Data Tracker. In Canada, 1.5 million 12 – 17 year olds have received the vaccine COVID-19 vaccination coverage in Canada - Canada.ca
The MHRA is collecting data concerning any adverse reactions observed to vaccine treatment through our Yellow Card Scheme. We are regularly publishing Yellow Card data associated with COVID-19 vaccinations. Yellow Card data for drugs is routinely published on the Yellow Card website, with vaccine data available on request. However, for COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly.
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
If you have a query about the information provided, please reply to this email
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Yours sincerely
MHRA Customer Service Centre