FOI release

Freedom of Information request on blood conditions following Pfizer COVID-19 vaccine (FOI 21/663)

Published 29 December 2021

9th July 2021

FOI 21/663

Dear

Thank you for your Freedom of Information request dated 11th June 2021, under which you requested the following information:

• How many cases of Low platelets/ITP have been reported after having the Pfizer vaccine since it’s rollout in the UK
• How many of these cases also had the covid virus prior to having the vaccine?
• What guidance was given to covid patients prior to having the vaccine e.g. how long should they wait?
• What course of treatments are being given to these cases who have developed a rare blood condition after having the Pfizer vaccine? I would like stats broken down by borough if possible and you can reword to keep within costs. Also advise if there is a fee and timescales for completion.

I am pleased to provide you with the information requested where possible within the MHRA’s remit.

• How many cases of Low platelets/ITP have been reported after having the Pfizer vaccine since it’s rollout in the UK

The MHRA publishes a weekly summary of Yellow Card reporting which can be found on this link:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

In this publication, under Annex 1: Vaccine Analysis Print you will find the specific information you have requested surrounding these suspected case reports with the Pfizer/BioNTech vaccine. Please note that reports can be found under both the reaction name ‘Platelet count decreased’ and ‘Immune thrombocytopenia’. As stated in the weekly summary, it is important to note that that Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the medicine or vaccine may have caused the side effect. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated.

Whilst we note that your question refers specifically to low platelets/immune thrombocytopenia, however it may be of interest to note that up to 23 June 2021, the MHRA had received Yellow Card reports of 12 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the UK following use of the COVID-19 Pfizer/BioNTech vaccine. These events occurred in 5 women, and 7 men aged from 31 to 91 years, and the overall case fatality rate was 8% with one death reported.

• How many of these cases also had the covid virus prior to having the vaccine?

The MHRA does not collect information exclusively on COVID infections; this information is only asked for when a possible reaction to a COVID-19 vaccination is reported via the Yellow Card scheme. Further information on COVID infections can be found on the Daily Summary and you can request additional information from Public Health England (PHE). Regarding the information on COVID infection in relation to Yellow Card reports of thrombus, this information is not available across all reports; however, MHRA works across the healthcare system to consider the totality of the data in the case reports when evaluating the evidence.

• What guidance was given to covid patients prior to having the vaccine e.g. how long should they wait?

Please may I refer you to the information for UK recipients document for the Pfizer/BioNTech COVID-19 vaccine product, in which contraindications and special considerations for receiving the vaccine are provided in section 2 under the sub-headings ‘COVID-19 mRNA Vaccine BNT162b2 should not be given’ and ‘Warnings and precautions’ respectively. The administration of COVID-19 mRNA Vaccine BNT162b2 should be postponed in individuals suffering from acute severe febrile illness. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Furthermore there is specific guidance in the PHE’s COVID-19: the green book, chapter 14a which further states:

There is no evidence of any safety concerns from vaccinating individuals with a past history of COVID-19 infection, or with detectable COVID-19 antibody.

Vaccination of individuals who may be infected or asymptomatic or incubating COVID-19 infection is unlikely to have a detrimental effect on the illness. Vaccination should be deferred in those with confirmed infection to avoid confusing the differential diagnosis. As clinical deterioration can occur up to two weeks after infection, ideally vaccination be deferred until clinical recovery to around four weeks after onset of symptoms or four weeks from the first confirmed positive specimen in those who are asymptomatic.

• What course of treatments are being given to these cases who have developed a rare blood condition after having the Pfizer vaccine? I would like stats broken down by borough if possible and you can reword to keep within costs. Also advise if there is a fee and timescales for completion.

As you may be aware, the MHRA is a government agency that continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines and vaccines is positive at the time of licensing and remains so thereafter. As such, clinical practice is outside the remit of the MHRA and the care and treatment of patients is the responsibility of the attending healthcare professional, ensuring that the treatment plan is tailored to each patient. Therefore, the MHRA cannot comment on the treatments being given nationally in clinical practice.

To conclude, I would like to take this opportunity to reiterate that vaccine safety, along with the safety of all medicines is of paramount concern to the MHRA. The MHRA continuously monitors the safety of vaccines, with regulatory action taken if any serious risks were confirmed.

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