FOI release

Freedom of Information request on COVID-19 Vaccine Adverse Reaction Data Estimates (FOI 20-505)

Published 24 March 2021

Thank you for your enquiry dated 2nd December 2020.

You asked for the following:

Estimates of the following:

· The overall expected ADR’s

· In in turn these figures by age.

· The list of expected ADR’s in all groups, and then by age.

· How many prolonged hospitalisations are expected, and then by age.

· How many long term complications, and then by age.

· The estimated number of fatalities, and by then by age.

· The source(s) of the information you are relying on to make these estimates.

To confirm there will be full public disclosure of these adverse effects.

To ensure the public will be widely informed.

All medicines and vaccines have the potential to cause side effects and the MHRA are responsible for monitoring the safety of all medicines and vaccines as well as medical devices and other healthcare products in the UK.

The Yellow Card scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. The scheme is run by the MHRA and currently relies on voluntary reporting of suspected ADRs by health professionals and patients. The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market.

With any major new vaccination campaign we always develop a proactive vigilance strategy, and COVID vaccines are no exception. This is not because we think they will be unsafe. A number of previous vaccination campaigns have been considered in order to derive estimates of ADR volumes that might be anticipated in a forthcoming vaccination campaign when a Covid-19 vaccine or vaccines become available. Actual numbers of reports will be dependent on various factors including the number of doses administered and use of concurrent treatments (for instance to manage fevers). Our past experience with other new immunisation campaigns is that we tend to receive around 1 Yellow Card report per 1,000 doses administered and we have prepared our surveillance systems on that basis. Most of these are mild and short-term, and not everyone gets them. It is important to note that a report of a suspected side effect is not proof that the vaccine caused it but a suspicion by the reporter that the vaccine may have caused the side effect.

The estimate for the number of Yellow Card reports we expect to receive for COVID-19 vaccines has been based upon the rate of reporting for other vaccinations following their introduction into the routine immunisation schedule. The rate of reporting is not an exact reflection of the safety profile of the vaccine, rather it likely depends on a number of factors including the characteristics of the vaccinated population and the setting in which vaccination is administered. Given the majority of routine vaccines are given to children there is some uncertainty about the rate of reporting we might see in the adult population vaccinated with COVID-19 vaccines. However, we do know that serious events are more likely to happen naturally in an older population in the absence of any association with vaccination and that these events are more likely to be reported to us.

We will be publishing Yellow Card data on our website and the public will be kept informed.

Kind regards,

Pharmacovigilance Service Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Email: pharmacovigilanceservice@mhra.gov.uk Stay connected: mhra.gov.uk/stayconnected