FOI release

Freedom of Information request about regarding adverse clotting events post COVID-19 Vaccine AstraZeneca (FOI-480)

Published 28 June 2021

Thank you for your Freedom of Information (FOI) request regarding adverse clotting events post COVID-19 Vaccine AstraZeneca. Please accept our apologies in sending this response to you later than the deadline date.

Under the FOI act, you have requested to be provided with the following:

1) Are MHRA tracking thrombotic events in people following AZ vaccination that are not associated with thrombocytopenia? If not, why not?

2) As the yellow card system is stated by MHRA to be voluntary, what proportion of thrombotic events post AZ vaccine are assumed to actually be reported in the MHRA published data?

3) Given the public health risk, why is MHRA not advising the reporting of thrombotic events to be a compulsory requirement on healthcare professionals to ensure data published is more accurate?

4) Is MHRA following up with each patient suffering with severe reactions or events to ensure they are quickly investigated to determine if the cause is likely to be the AZ vaccine? If not, can MHRA confirm which organisation is doing the medical follow-up?

As you may be aware, the MHRA publish a weekly COVID-19 ADR summary alongside analysis prints for each vaccine, these can be found here. It currently pertains to data received up to and including the 28th April 2021. This contains details regarding specific reports including thrombo-embolic events with concurrent low platelets.

On the 18th March the MHRA advised that following a rigorous scientific review of all the available data, said that the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca and that a detailed review into five UK reports of blood clots in cerebral veins was ongoing. The Agency has carefully considered the evidence alongside specialist input from the Government’s independent advisory body, the COVID-19 Vaccines Benefit Risk Expert Working Group, which includes advice from lay representatives and leading haematologists. This has been discussed each week in our ADR report, and a further statement published on the 7th May.

The MHRA are proactively monitoring the safety of all COVID-19 vaccines approved by the MHRA in near real-time safety monitoring at population level and will therefore continue to monitor thrombotic events without thrombocytopenia alongside all other side effects.

Many factors can affect reporting levels and the precise level of reporting for COVID-19 vaccines cannot be quantified. We are raising awareness of our dedicated Yellow Card reporting site for medicines and vaccines used in the pandemic and are encouraging everyone to report any suspected side effects to us. Additionally, we take into account the variable levels of reporting as part of our monitoring procedures.

We are working with public health bodies and encouraging all healthcare professionals and patients alike to report any suspected ADRs to the Yellow Card scheme. The MHRA has also worked with its partners within the health system, such as devolved administrations, National Health Service (NHS), Public Health England, Joint Committee on Vaccination and Immunisation (JCVI) and the National Immunisation Service so that planned COVID-19 vaccination programme communications include information about the Yellow Card scheme. Every vaccinee should receive a copy of the product information which contains information about the Yellow Card scheme and inform them that they can self-report any suspected side effects to the MHRA. This is coupled with raising awareness of the Yellow Card scheme through planned national briefings at Number 10 and through MHRA’s targeted social media campaign. As expected, reports gradually increase in line with an increase in doses administered and the MHRA are confident that voluntary reporting levels are in sufficient quantity to detect safety signals and conduct robust benefit/risk assessments and update our advice. We have worked closely with Public Health England, devolved administrations and the haematology community to ensure system wide awareness and coordination reporting of blood clots occurring with low platelet counts.

Reports are routinely followed up by the MHRA where additional information is required to aid in the assessment of a case or signal detection activities. The MHRA takes all reports very seriously and every report is fully evaluated by the MHRA and kept under continual review. We follow-up all fatalities, where permission has been provided to do so, for further information, including post-mortem details if available. All details within a report are thoroughly assessed to consider whether the vaccine may have caused the event, or whether the events were likely to be purely coincidental and due to underlying illness. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the event alongside data available from international sources. This is further considered by the Commission on Human Medicine and its Expert Advisory Groups. Healthcare professionals hold individual patient duty of care under their role as practitioners.

Additional to this, the MHRA are regularly updating the Yellow Card reporting form in response to the data emerging from the COVID-19 vaccines. An example of this is the recent change to our reporting form, if a thromboembolic event is reported specific questions are asked regarding presentation and tests performed as these help us to evaluate and assess these specific reports.

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