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.