FOI release

Freedom of Information request on coronavirus vaccinations (FOI 21-375)

Published 28 June 2021

7th May 2021 FOI 21/375

Dear

Thank you for your email dated 07th April 2021 which included several questions pertaining to the Coronavirus vaccinations. Please see below further details in answer to your request:

1. What happens to the thousands of reports to the Yellow Card scheme? Where does the data go and how is it used? All Yellow Card reports we receive are promptly entered onto the MHRA’s Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports 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. For the COVID-19 vaccines we supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks – in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. We also take into account the international experience based on data from other countries using the same vaccines. For further information on how we use the data we collect please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk).

2. Where is the archived data for the weeks where data has been produced? I can only see one week at a time then it disappears. During the pandemic, information is continually changing and the data on our website is updated on a weekly basis to reflect this. This is to ensure the most current and accurate data is readily available to the public. For example, we may receive new information about a case which changes the way it is classified and therefore the data on our website needs to be modified in line with this. The latest summary of Yellow Card reporting on Coronavirus vaccine ADRs can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions. At the bottom of this page you can find a timeline of the updates. Unfortunately the .gov.uk site does not facilitate the hosting of previous weeks reports and so we are working hard to make these available soon via the Coronavirus Yellow Card reporting site.

3. Should those on warfarin and other anti coagulants have a recent Hi up to date INR test prior to vaccination? There are no contraindications to the administration of the COVID-19 vaccines with warfarin or other anti-coagulation medicine, and nor are INR tests required prior to vaccination.

4. I believe both the mRNA vaccines Moderna and Pfizer have PEG included in the ingredients. Can you tell me please how patients are being informed of this in case they’ve ever experienced an anaphylactic reaction to PEG? A list of excipients can be found in the product information leaflets for the Moderna and Pfizer COVID19 vaccine which can be found here: https://coronavirus-yellowcard.mhra.gov.uk/productinformation/ In the Information for Recipients, under Section 6 ‘Contents of the pack and other information’, it states that the vaccines contain PEG as one of the ingredients. Both of these leaflets state that if individuals are allergic to the active substance or any of the other ingredients of the vaccine (listed in section 6) then they should not receive the vaccine.

5. Are patients being given manufacturers leaflets with the contraindications prior to vaccination so they may make an informed decision? The vaccination user journey is available online here. On arrival for a vaccination, recipients are checked that they do not have symptoms that would prevent them having a vaccine. They are asked questions about their medical history and for consent for the vaccine, at this point they have the opportunity to ask any questions they may have regarding the vaccination. Once the vaccine has been given, they will be given a leaflet which includes details on possible side effects and how to report those to the MHRA. The product information for all approved vaccines is available to patients online: Patient Information Leaflets for the Pfizer BioNTech, Astra-Zeneca and Moderna COVID-19 vaccines. Patients are also encouraged to discuss any concerns they may have prior to receiving the vaccine with their healthcare professional.

6. It would appear many suffering severe adverse effects are not being followed up by the MHRA/NHS or their own GP’s after reporting. Why? Some are very sick and are not receiving care. Their GPs are following MHRA line in saying the effects will get better over time, however I know some who have been diagnosed with Guillain Barre and others who have had Cerebrovascular Accidents. Life changing, life ending. 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 event and fatal outcome 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 death 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.

7. As the Covid vaccine is a BLACK TRIANGLE medication and as such under intense scrutiny in the U.K. and in Europe please could you give me more information regarding what the MHRA definition of ‘scrutiny’ is and what safeguarding measures are in place to address the many yellow card reports. Also what risk assessments have been done to ensure patient safety after receiving the ‘jab’? One of the MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place, as mentioned above, a proactive strategy to do this for COVID-19 vaccines: COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk). 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.

8. You said a child was more at chance of being run over a bus than catching Covid so please explain why trials on other drugs and the AZ nasal spray continue on children? Are you still expecting to vaccinate babies and children? There is no routine vaccination of children underway or currently planned as none of the 3 authorised vaccines for use in the UK are licensed for use in those under the age of 16 years. Children and adolescents can catch the Covid-19 virus, and in some rare cases, this can lead to serious symptoms, long term problems or death, mainly in children with underlying illnesses. The green book mentions that “given the very high risk of exposure to infection and outbreaks in institutional settings, vaccination may be considered for children with severe neuro-disabilities who tend to get recurrent respiratory tract infections and who frequently spend time in specialised residential care settings for children with complex needs”. https://www.gov.uk/government/publications/covid-19-the-green-bookchapter-14a The MHRA is considering very carefully all activities for the generation of data supporting the safe and effective use of COVID vaccines in the paediatric population. MHRA will look at all applications for clinical trials, based on the merits of that trial and the data that is available at that time and take appropriate advice from the Commission on Human Medicines.

9. Has the vaccine been designed with regard to the elderly. I am concerned as I know the old flu jabs were age appropriate. I’m sure you are aware of the effects of vaccines and medications on an older immune system? Immunosenescence. The clinical trials for over 55’s are both scant and inadequate. Details of the clinical trials that were submitted to MHRA, including the age groups of participants in the clinical trials, are presented in the Public Assessment Reports (PARs) for each authorised vaccine. These PARs are accessible via the links below. https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

10. Professor Van Tam likens the side effects to those on a paracetamol packet. This recommends not giving it to those with blood clotting problems, kidney and liver disease, those on certain antibiotics and anti-nausea medication. It also states that serious side effects such as breathlessness, rash etc should be immediately reported to a Doctor. How are those taking the Vaccine informed if the leaflet is only given POST vax? See response to question 5.

11. How many of these serious adverse effects are NOT attributable to the vaccine? What evidence is there to support the statement when clearly no postmortems or follow ups are being carried out? A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or event in the days and weeks after vaccination. A high proportion of people vaccinated in the vaccination campaign so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination. Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly. Please refer to question 6. Please also refer to question 7 to find the link to the COVID-19 surveillance strategy.

12. Can pregnant women take this vaccine with total reassurance that their unborn babies will be safe? Currently I’m seeing many reports of still birth, spontaneous abortion and premature labour on both the Pfizer and AZ data. Regarding use in pregnancy, the COVID-19 vaccines available in the UK have been shown to be effective and to have a good safety profile and the early COVID-19 vaccines do not contain organisms that can multiply in the body, so they cannot infect an unborn baby in the womb. Non-clinical evidence is required before any clinical studies in pregnancy can start, and evidence from non-clinical studies of the Pfizer BioNTech, Astra-Zeneca and Moderna COVID-19 vaccines has been reviewed by the MHRA and has raised no concerns about safety in pregnancy. Further information regarding this can be found at the following link: https://www.gov.uk/government/publications/COVID-19-vaccinationwomen-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/COVID-19- vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding. As pregnant women were not included in the clinical trials which led to the authorisation of the above vaccines, information on pregnancy outcomes, including miscarriage, is being closely monitored by the MHRA, and other medicines regulators like the Food and Drug Administration (FDA) in the United States (US) and the European Medicines Agency (EMA) in Europe, through spontaneous reporting systems and via registries of people who received the vaccine whilst pregnant. Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. Sadly, miscarriages, stillbirths and premature labour occur in pregnancies in the UK outside of pandemic conditions, so some instances of these would be expected to occur following vaccination purely by chance. Miscarriage is estimated to occur in about 20 to 25 in 100 pregnancies in the UK and most occur in the first 12 weeks (first trimester) of pregnancy and stillbirths are estimated to occur in about 8 in 100 pregnancies. The MHRA has received some reports of miscarriage and a few reports of stillbirth and preterm delivery respectively following vaccine exposure in pregnancy which we are closely monitoring. There is currently no pattern to suggest an elevated risk of miscarriage, stillbirth or preterm delivery related to exposure to the COVID-19 vaccines in pregnancy. We understand that the FDA reached similar conclusions regarding rates of these events in the US. The MHRA continues to closely monitor reports of vaccine exposure in pregnancy. If any further data or evidence becomes available which suggests these vaccines are unsafe for use in pregnancy, current advice will be reviewed as soon as possible by our expert scientific assessors.

13. Could you provide more context within the data such as age, sex and circumstances similar to the USA Vaers reports. We intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as interactive drug analysis profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports, and will be available for each of the COVID-19 vaccine in use in the UK. As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld. We will send you a link to the iDAPs once they are published.

14. It would appear that the advice on the manufacturer’s leaflets do not seem to correlate with MHRA advice? How is this possible? The product information leaflets for the COVID-19 vaccines can be found both on the gov.uk website and the dedicated Yellow Card Coronavirus website here: https://coronavirus-yellowcard.mhra.gov.uk/productinformation. These contain the same versions of the information.

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