COVID-19 Vaccine Patient Information Leaflet

Campaign Start:

03/05/2021

Campaign End:

Background

What is a Patient Information Leaflet?

A Patient Information Leaflet (PIL) is a document that gives important information about a medicine, drug, vaccine or other medical treatment.  While it can contain detailed medical information, the aim is that the document be written in as lay terms as possible, thereby enabling the potential recipient of the medical treatment to make an informed choice.

There is a requirement in law for all medicines to have a Patient Information Leaflet.

PILs are required to contain standard information and to have that information arranged in specific sections, so that the documents are easier to use and compare.  However the regulations do not require that these sections always be in the same order, which would further help ease of use and comparison.

The required sections are:

Identification of the medicine

The name, the active substance(s), the pharmaceutical form, and the strength of the product should be stated.

Therapeutic indications

The conditions for which the medicine is authorised must be listed. This section should include any benefit information considered appropriate.

Information necessary before taking the medicine

Situations where the medicine should not be used, any precautions, warnings, interactions with other medicines or foods, information for
special groups of patients (pregnant or nursing mothers), and any effects the medicine may have on the patient’s ability to drive.

Dosage

How to take or use the medicine including both the route and method of administration, how often it should be given, how long the course of
treatment will last, what to do if a dose is missed and, if relevant, what do in the event of an overdose and the risk of withdrawal effects.

Description of side effects

All the effects which may occur under normal use of the medicine and what action the patient should take if any of these occur. These should be
listed by seriousness and then by frequency.

Additional information

This covers information on excipient details, a description of the product, registered pack sizes, storage conditions, and name and address of the
Marketing Authorisation Holder (MAH) and manufacturer.

Action Needed

While the law requires a Patient Information Leaflet for every medicine, when and how these are given to patients varies.  It seems that too often these are given to the patient after the treatment has been prescribed or administered rather than before.

It has been brought to our attention that senior managers in some NHS Trusts are also instructing staff involved in the rollout of COVID-19 vaccinations to not give patients the PIL at all.

This is a grave concern, especially when there are millions of pounds being spent by the government on “marketing” a medicine that has no “marketing authorisation”.

We believe that everyone has the right to make an informed choice when it comes to their healthcare.  This is doubly important when the treatment they are undertaking is still in the testing phase and has not been fully approved.

We are therefore publicising where you can get the PILs for the four COVID-19 vaccines and encouraging everyone to read these thoroughly before having a vaccination.  We also encourage everyone to speak to their GP or other healthcare professional if they have any questions or concerns, if they are on any kind of medication (as there is no data on interactions with other medications) or if they have allergies or a tendency towards adverse reactions to substances similar to those contained in the vaccines.

The button below will take you to the NHS website page about the COVID-19 vaccines.  From there you can use the links under the section “How Safe Is The COVID-19 Vaccine” to navigate to the documents relating to the different vaccine products.

Or you can use the following links:

Information for UK Recipients on Pfizer/BioNTech COVID-19 Vaccine

Information for UK Recipients on COVID-19 Vaccine AstraZeneca

Patient Information Leaflet for COVID-19 Vaccine Moderna

Patient Information Leaflet for COVID-19 Vaccine Janssen

If you would like to read even more about the COVID-19 vaccines, our further reading list may be of help.

 

TAKE ACTION

Essential Context for Understanding this report

These reports contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of the COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the report alone. When viewing the report, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.

  • It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of the condition being treated rather than being caused by the vaccine.

  • Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction. When monitoring the safety of medicines and vaccines, MHRA staff carry out careful analysis of these factors.

  • It is not possible to compare the safety of different vaccines by comparing the numbers presented in the vaccine reports. Reporting rates can be influenced by many factors including the seriousness of the adverse reactions, their ease of recognition and the extent of use of a particular vaccine. Reporting can also be stimulated by promotion and publicity about a product.

For a vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people receive vaccinations without having any serious side effects.

Risks and benefits of medicines

For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions. It is important to note that most people take medicines without suffering any serious side effects.

All medicines can cause reactions. The patient information leaflet accompanying the medicine, or available from your pharmacist, lists the known side effects associated with the medicine. Healthcare professionals such as doctors and pharmacists can also provide this information. Information on side effects of medicines can be found on the NHS website.

Monitoring the safety of medicines and vaccines

Information collected through the Yellow Card scheme is an important tool in helping the MHRA and CHM monitor the safety of medicines. Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects.

If a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine or vaccine, and how it compares with other medicines used to treat the same condition.

The MHRA will take action, if necessary, to ensure that the product is used in a way that minimises risk, while maximising patient benefit. Such changes may include, for example, restricting the indication, or special warnings and precautions. Rarely, a drug may need to be withdrawn from the market if the risk of side effects is considered to outweigh the benefits of treatment. Please see our How we monitor the safety of medicines section for further information.

Use of Yellow Card data for publication

If you wish to copy or circulate the information contained within a report to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card scheme in research and for publication, but wish to ensure that the limitations of interpretation of the data are made clear.

If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice on how the Yellow Card information might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Deputy Director, Safety and Surveillance Group by email.