Both the manufacturing process for Pfizer-BioNTech and the presence of excipients may affect individuals perceptions of its suitability.
Below are facts to help you answer questions from patients.
Animal or human derived content
Suitability for vaccination is unlikely to be affected for individuals avoiding animal or human derived content.
Information related to manufacture
Information from the manufacturer states that:
- A material used in the early stage of the manufacturing process of COVID-19 mRNA Vaccine BNT162b2 contains a component that is derived from bovine milk. The bovine milk is fit for human consumption and complies with bovine spongiform encephalopathy (BSE)/transmissible spongiform encephalopathies (TSE) regulations.
- Other raw materials used in the manufacture of the vaccine are of non-animal origin.
- All lipid excipients used in the vaccine are either from plant-derived sources or are synthetic and have no animal components.
- The manufacturer cannot guarantee that minute amounts of substances are not contained in raw materials obtained from their suppliers.
The manufacturer states that animal or human cell lines are not used in the manufacturing process of the COVID-19 mRNA Vaccine BNT162b2.
Information from the manufacturer states that eggs are not used during the manufacturing of the vaccine and the final product does not contain eggs. However, the manufacturer cannot guarantee that minute amounts of substances, such as egg, are not contained in raw materials obtained from their suppliers.
The excipients listed in the manufacturer’s information are as follows:
- ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
- ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
- potassium chloride
- potassium dihydrogen phosphate
- sodium chloride
- disodium hydrogen phosphate dihydrate
- water for injections
Note, this vaccine contains polyethylene glycol (PEG) and should be noted when considering for use in patients with an allergy to PEG.
The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’, and contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium‑free’.
Suitability for vaccination is unlikely to be affected for individuals avoiding gluten.
Information from the manufacturer states that gluten is not used during the manufacturing of the vaccine and the final product does not contain gluten. However, the manufacturer cannot guarantee that minute amounts of substances, such as gluten, are not contained in raw materials from their suppliers.
The British Islamic Medical Association ‘Fasting and Covid Vaccinations’ Q&A document states that receiving a COVID-19 vaccine does not invalidate the fast and includes useful advice for fasting patients and adverse effects following vaccination.
The British Islamic Medical Association has released a position statement. about the Halal status.
Suitability for vaccination is unlikely to be affected for individuals avoiding thiomersal.
Public Health England’s Immunisation Against Infectious Disease (the Green book) highlights that thiomersal is a mercury based compound used as a preservative in the manufacture of some vaccines for many years and has been associated with some safety concerns. However, this vaccine is preservative free and therefore does not contain thiomersal.
- Changes reflect availability of licensed product Comirnaty.
- Link to British Islamic Medical Association information about Fasting (Ramadan) added
- Page title changed from "Excipients information for Pfizer-BioNTech COVID-19 Vaccine"
- Page summary and purpose changed to enable application of excipients information in practice
- Information expanded to capture all relevant points related to diet and AstraZeneca COVID-19 vaccination