Freedom of Information request on blood clotting following AstraZeneca COVID-19 vaccine (FOI 21/937)
Published 17 January 2022
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14th September 2021
FOI 21/937
Dear
Thank you for your letter dated 22nd April 2021, where you requested information relating to the Astra- Zeneca COVID-19 vaccination. I am sorry to hear of the symptoms that you experienced and hope you have recovered now. Please accept our apologies for the delay in responding to your letter.
The information you have provided in your report has been entered onto our database and assigned the reference number. If you would like to add any additional information to your case, or amend the details previously provided, please email yellowcard@mhra.gov.uk, or call the Yellow Card freephone at 0800 731 6789. Please include the Yellow Card reference number given above so that we can ensure the new information is attached to the correct case. In particular it would be helpful to have the following information, if available:
- How are you feeling now? Have you fully recovered, and if so, when did your side effects stop?
- Please can you provide the batch number of your first AstraZeneca COVID-19 vaccination that you received on 7th March 2021, if known.
- Did you take any treatment for your side effects? If so, please could you provide details.
- Were you taking any other medications at the time of, or up to three months before, the onset of the reactions you experienced? If so, please can you provide us with the details including the start and stop dates, where applicable, the dose you were taking and the reason you were taking them?
- Do you have any relevant past or current medical conditions, including any known allergies as well as any previous adverse reactions following administration of any other vaccines? If so, please can you provide us with the details.
Please find below the responses to each of your queries:
I would also like to ask the MHRA under the Freedom of Information Act:
- When (the date) your organisation became aware that the AstraZeneca vaccine were causing these serious side effects, death of blood clots of individuals who had received the vaccine.
One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals. If you would like further information on our proactive vigilance strategy for COVID-19 vaccines, please see the report available here:
With regards to your question above, I can confirm that the MHRA released an announcement on 7th April 2021 highlighting the possible link between the COVID-19 AstraZeneca vaccination and blood clots, titled “MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots”. The MHRA concluded that “The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition”. The announcement can be found at the following link:
Another announcement was made on 7th May 2021, titled “MHRA response to the Joint Committee on Vaccination and Immunisation (JCVI) advice on COVID-19 Vaccine AstraZeneca for people aged under 40”, which stated that the MHRA position “remains that the benefits of the COVID-19 Vaccine AstraZeneca against COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks for the vast majority of people. The balance of benefits and risks is very favourable for older people but is more finely balanced for younger people and we advise that this evolving evidence should be taken into account when considering the use of the vaccine, as JVCI has done.” The announcement can be found at the following link:
On 14th June 2021, the following article was published to the Public Health England and UK government website regarding the issue of COVID-19 vaccinations and blood clotting; COVID-19 vaccination and blood clotting, which looks into the concern about blood clots, which vaccination will be offered to different age groups, discussion on the benefits and risks, and what to look out for after your vaccination. The announcement can be found at the following link:
- Were the MHRA aware of the serious side effects, deaths from the AstraZeneca vaccine before the European Union announcement.
As mentioned above, the MHRA continually reviews and monitors the safety of the COVID-19 vaccinations, and when there is a safety concern, this is communicated via press release to the general public. As above, the MHRA first published communications regarding COVID-19 AstraZeneca vaccine and blood clots on 7th April 2021. This was followed up by further communication on the 7th May and 14th June, when further information became available.
- When did, (date) did the MHRA alert doctors, medical practitioners, GP’s, to the symptoms, side effects of the vaccine, blood clots, low platelets, cerebral venous sinus thrombosis to ensure the correct diagnosis was made so that the appropriate and prompt medical action was carried out to save lives.
As above, the guidance to health care professionals (HCPs) and public was published on 7th April 2021, 7th May 2021, and 14th June 2021.The MHRA are committed to transparency and as you may be aware, we are publishing a weekly summary of Yellow Card reporting, and any changes to guidance are included in these weekly reports, which can be found here:
The guidance regarding blood clotting following COVID-19 vaccination states the following:
Although serious side effects are very rare, if you experience any of the following from around 4 days to 4 weeks after vaccination you should seek medical advice urgently:
- a new, severe headache which is not helped by usual painkillers or is getting worse
- a headache which seems worse when lying down or bending over or
- an unusual headache that may be accompanied by: blurred vision, nausea and vomiting, difficulty with your speech, weakness, drowsiness or seizures
- new, unexplained pinprick bruising or bleeding
- shortness of breath, chest pain, leg swelling or persistent abdominal pain
You may also be interested to know that the product information for the COVID-19 vaccines, which includes information relating to known side effects, is available on the Yellow Card Coronavirus website (https://coronavirus-yellowcard.mhra.gov.uk/productinformation). The product information has been, and will continually be updated to reflect any guidance, and will be amended should further information come to light and reviewed.
- Have there been any further cases or fatalities of blood clots low platelets, cerebral venous sinus thrombosis of individuals after receiving the second dose.
As you may be aware, the weekly summary of Yellow Card reporting referenced above includes sections relating to thromboembolic events with concurrent thrombocytopenia, where data such as the number of reports and fatal events are presented. The number of reports of thromboembolic events with concurrent thrombocytopenia, including a second dose breakdown are outlined within the publication.
The MHRA’s position is that “vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. Everyone should continue to get their vaccination when asked to do so unless specifically advised otherwise, and as with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored. Also, cases of an extremely rare specific type of blood clot with low blood platelets continue to be investigated”.
In your letter you also requested advice as to whether you should receive your second dose, however, unfortunately, we are unable to provide medical advice on individual cases, therefore I would recommend that you discuss any concerns regarding the second dose of the COVID-19 vaccine with your healthcare professional who will be in the best position to advise you. It is a key role of the MHRA to provide doctors with advice on the safe use of medicines; however, the final responsibility for the clinical care of the patient remains with the doctor given their clinical expertise and knowledge of your medical history.
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