FOI release

Freedom of Information request on yellow card reports for COVID-19 vaccines (FOI 21/916)

Published 25 February 2022

9th September 2021

FOI 21/916

Dear

Thank you for your email dated 10th August, where you asked for information on the following:

1) How is the MHRA investigating over 1 million adverse events and or deaths due to the COVID-19 vaccines?

2) What is the estimated percentage of actual reports making it to the MHRA? Some studies show 1-5% in other reporting systems across the world.

3) If all events are correct how is the injection deemed safe for humans?

4) Will the vaccines only be fully approved (not emergency use) after the clinical trials end in 2023?

In response to your first question, the MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines in near real-time safety monitoring at a population level and we have in place a proactive strategy to do this. There are four strands to the proactive vigilance strategy, which combine to address the relative strengths and weaknesses of each form of vigilance. As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring to ensure that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as pharmacovigilance. This ensures that any potential medium- and long-term safety issues are promptly and adequately evaluated.

One of the four strands involves collecting reports of suspected adverse events that have occurred in association with the vaccine. A team of MHRA scientists will continually review these reports and will contact reporters to obtain more information, where required. Scientific and clinical assessment will be used to determine if an individual or series of reports indicate a new safety ‘signal’. As part of our signal detection processes, all adverse reaction reports received are assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary. We also receive independent advice from the Commission on Human Medicines (CHM) which is responsible to advise on the impact of any safety issues including fatal cases on the balance of risks and benefits of COVID-19 vaccines.

As you will be aware, a summary of Yellow Card reporting concerning the COVID-19 vaccines is published each week and can be found here. It is important to note that a reported reaction and its subsequent inclusion in our weekly summary of Yellow Card reporting does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. When any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

In terms of your second question, the reporting rate for spontaneous adverse drug reactions (ADRs) is variable and can depend on a multitude of factors. Although some historical studies have estimated only 10% of ADRs are reported, the actual rate is unknown and variable because it is influenced by public awareness and seriousness of the event. These estimates should not be used as indicators of the reporting rate for COVID-19 vaccines, for which there is high public awareness of the Yellow Card scheme and the reporting of suspected reactions. We take into account the variable levels of reporting as part of our monitoring procedures.

Further to the third point, no COVID-19 vaccine would be approved until it has demonstrated sufficient safety, quality, and efficacy through a robust clinical trial programme, as determined by the MHRA, and unless the evidence supports its use. The Public Assessment Reports (PARs) that are published very clearly contain MHRA’s assessment of the authorised vaccines. All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective COVID-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a COVID-19 vaccine. No stages in the vaccine development processes were bypassed. Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects.

Finally, the temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation, which have now been granted for the COVID-19 vaccines. Regarding the MHRA approval of the Pfizer/BioNTech, Moderna and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and PARs for each vaccine) are available on the MHRA website.

Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen

In addition, a marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to these are provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division