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.

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