FOI release

Freedom of Information request on the statistics following the COVID-19 vaccination (FOI 21/870)

Published 20 January 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-30-august-2021/freedom-of-information-request-on-the-statistics-following-the-covid-19-vaccination-foi-21870

31st August 2021

FOI 21/870

Dear

Thank you of your email dated 31st July 2021, where you requested the following information relating to the COVID-19 vaccination campaign:

Under the freedom of information act for people over 18 years old, could you provide me with:

1) For each month since December 2020, please provide the:

a. The number of deaths amongst people who have received at least one COVID injection

b. The number of deaths amongst people who have not received any COVID injections

c. The cumulative total number of people who have received at least one COVID injection

d. The total number of people aged 18 or older.

2) For each individual month since December 2020, for the illnesses reported on the Yellowcard system, what is the rate per 100000 people of each illness amongst those who have received at least one COVID injection? What is the rate per 100000 people for these conditions amongst those who have not received any COVID injections for each month?

3) For each individual month since December 2020, what is the infant mortality rate for breast feeding mothers who have received at least one COVID injection and those mothers who have not received any COVID injections?

4) For each individual month since December 2020, what is the miscarriage rate for expectant mothers amongst those who have received at least one COVID injection and for expectant mothers who have not received any COVID injections. Please find below the responses to each of your queries:

Question 1

This information is not part of the Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) remit, and therefore the MHRA do not hold this data. This falls within the remit of the Public Health agencies within the devolved administrations, who are facilitating the delivery of the national COVID-19 vaccination programme. The following website may have some useful information for you regarding the rollout of the vaccination campaign, Daily summary - Coronavirus in the UK (data.gov.uk), or you may wish to contact the devolved administrations directly for data on the rollout in the UK:

The Office of National Statistics also holds information, including data and analysis on coronavirus within the UK, which may be of interest to you and can be found here: Coronavirus (COVID-19) - Office for National Statistics (ons.gov.uk)

The MHRA are committed to transparency and as you may be aware, we are publishing a weekly summary of Yellow Card reporting which is available to view here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

Within Annex 1 of the weekly report you will find Vaccine Analysis Prints summarising the Yellow Card reports we have received for each of the vaccines. Please note that when considering the spontaneous Adverse Reaction (ADR) data, it is important to be aware that a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental. This publication also includes information on the number of fatal reports that the MHRA have received. Please note that review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.

Question 2

Reporting to the Yellow Card scheme is voluntary and whilst we encourage reporting, even if there is only a suspicion of a side effect, ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. It is therefore important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. As mentioned in the weekly summary, the overall reporting rate is in the order of 3 to 7 Yellow Cards per 1,000 doses administered for the Pfizer/BioNTech vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna. It is known from the clinical trials that the more common side effects for all vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms).

In addition to this, we do not hold data that compares the number of Yellow Cards per reported reaction to the number of individuals who have received at least one COVID injection. Whilst the MHRA does hold some of the information that you have requested, this would require calculation per reaction and would therefore be exempt under Section 12 of the Freedom of Information Act. Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.

We are also unable to provide comparative statistics for those who have not received a COVID-19 vaccine as we do not hold data on the background rate of illnesses within the UK. As this falls outside of the MHRA’s remit, you should contact the Office of National Statistics for this data: Contact us - Office for National Statistics (ons.gov.uk)

Question 3

The weekly summary does not currently include information relating to the use of COVID-19 vaccines during breast feeding. However, the MHRA are continuously reviewing reports of exposure to the COVID-19 vaccines during breast-feeding and should we receive reports that raise any concerns in this area, this will be communicated appropriately to healthcare professionals and the general public, including an addition to the weekly summary.

As in response to question two, we are unable to provide comparative statistics for those who have not received a COVID-19 vaccine as we do not hold data on the background rate of illnesses within the UK.

Question 4

As you may already be aware, the weekly summary of Yellow Card reporting does include important information on the safety of COVID-19 vaccines in pregnancy. As described in the most recent summary which includes data on reports received up to and including 18th August.

“The numbers of reports of miscarriage and stillbirth are low in relation to the number of pregnant women who have received COVID-19 vaccines to date (more than 65,000) and how commonly these events occur in the UK outside of the pandemic. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth.

Sadly, miscarriage is estimated to occur in about 20 to 25 in 100 pregnancies in the UK and most occur in the first 12 to 13 weeks of pregnancy (the first trimester). Stillbirths are sadly estimated to occur in about 1 in 200 pregnancies in the UK. A few reports of commonly occurring congenital anomalies and preterm births have also been received. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications.

Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant.”

The current advice of the Joint Committee on Vaccination and Immunisation (JCVI) is that the COVID-19 vaccines should be offered to those who are pregnant at the same time as non-pregnant individuals based on their age and clinical risk group. The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy. I hope this has given you due reassurance, but if you would like further information on our proactive vigilance strategy for COVID-19 vaccines please see the report available here: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance#proactive-vigilance-for-covid-19-vaccines

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

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