Background
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 the Pfizer-BioNTech Covid-19 vaccine 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 Pfizer-BioNTech Covid-19 vaccine.
Egg content
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.
Excipients present
Children 5 to 11 years presentation (10micrograms/dose)
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
- DSPC = 1,2-Distearoyl-sn-glycero-3-phosphocholine
- cholesterol
- trometamol
- trometamol hydrochloride
- sucrose
- water for injection
Note: this vaccine contains polyethylene glycol (PEG), which should be taken into consideration if planning to use in patients with an allergy to PEG
Adults and adolescents preparation (30micrograms/dose)
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
- DSPC = 1,2-Distearoyl-sn-glycero-3-phosphocholine
- cholesterol
- potassium chloride
- potassium dihydrogen phosphate
- sodium chloride
- disodium hydrogen phosphate dihydrate
- sucrose
- water for injections
- sodium hydroxide (for pH-adjustment)
- hydrochloric acid (for pH-adjustment)
Note: this vaccine contains polyethylene glycol (PEG), which should be taken into consideration if planning to 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’.
Gluten
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.
Jewish community
The Conference of European Rabbis has release a position statement.
Muslim community
Halal certification
There is no information on Halal certification for the Pfizer-BioNTech vaccine.
However, the British Islamic Medical Association has released a position statement .
Thiomersal content
Suitability for vaccination is unlikely to be affected for individuals avoiding thiomersal.
UK Health Security Agency (UKHSA – formerly known as PHE) 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.
Change history
- Added excipient list for children 5 to 11 years presentation (10micrograms/dose)
- Additional excipients (sodium hydroxide and hydrochloric acid - both for pH-adjustment), added to excipient list.
- Link to manufacturers information on egg content of vaccine added
- Links to Pfizer medical information documents updated
- Information regarding use during Ramadan removed from page.
- Changes reflect availability of licensed product Comirnaty.
- Link to British Islamic Medical Association information about Fasting (Ramadan) added
- Information expanded to capture all relevant points related to diet and AstraZeneca COVID-19 vaccination
- Page summary and purpose changed to enable application of excipients information in practice
- Page title changed from "Excipients information for Pfizer-BioNTech COVID-19 Vaccine"
- Published