Excipients information for Pfizer-BioNTech COVID-19 Vaccine

Helen Davis, UKMi, Director, North West Medicines Information CentrePublished

This page summarises and signposts to publicly available information that we’re aware of from professional and government bodies relating to the Pfizer-BioNTech

Summary

This page summarises and signposts to publicly available information that we’re aware of from professional and government bodies relating to the Pfizer-BioNTech COVID-19 vaccine.

This page highlights available data about the excipients contained in the vaccine and any potential adverse effects. The excipients in the vaccine may need to be considered by special patient groups e.g. vegans.

See also  Advising individuals with allergies on their suitability for Pfizer-BioNTech COVID-19 Vaccine.

Excipient content of the vaccine

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
  • 1,2-Distearoyl-sn-glycero-3-phosphocholine
  • cholesterol
  • potassium chloride
  • potassium dihydrogen phosphate
  • sodium chloride
  • disodium hydrogen phosphate dihydrate
  • sucrose
  • 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’.

Known adverse effects of the excipients

Excipients are included in the manufacturer’s information which states only hypersensitivity to the active substance or any of excipients listed as a contraindication for use.

Public Health England’s Immunisation Against Infectious Disease (the Green book) states that there are very few individuals who cannot receive the Pfizer-BioNTech COVID-19 vaccine and where there is doubt, rather than withholding vaccination, appropriate advice should be sought from the relevant specialist, or from the local immunisation or health protection team. The vaccine should not be given to those who have had:

  • a confirmed anaphylactic reaction to a previous dose of a COVID-19 vaccine
  • a confirmed anaphylactic reaction to any components of the COVID-19 vaccine

Thiomersal content

The 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.

Antibiotic content

The manufacturer’s information about antibiotic content states the following:

  • Kanamycin is used during the manufacturing process of one of the raw materials used in the vaccine production; however it is not expected to be in detectable quantities in the final product presentation.
  • No other antibiotics (such as penicillins, sulphonamides and neomycin) are used during the manufacturing process.
  • They cannot guarantee that minute amounts of substances are not contained in raw materials obtained from their suppliers.

Gluten content

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.

Nut content

The manufacturer states that nuts are not used during the manufacturing of the vaccine, and the final product does not contain nuts. However, the manufacturer cannot guarantee that minute amounts of substances, such as nuts, are not contained in raw materials obtained from their suppliers.

Soy content

The manufacturer states that soy is not used during the manufacturing of the vaccine and the final product does not contain soy.  However, the manufacturer cannot guarantee that minute amounts of substances, such as soy, are not contained in raw materials obtained from their suppliers.

Egg content

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

Our advice about the general considerations for excipients for vegan patients states that veganism avoids using animals as far as is practicable and possible’ and sometimes there are no alternatives to prescription medicines containing animal-derived ingredients.

Animal- or human-derived product content

The manufacturer provides the following information:

  • 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.

Halal certification

The manufacturer states that the vaccine was not submitted for halal certification prior to authorisation approval and they are currently investigating the submission/application process.

However, the British Islamic Medical Association has released a position statement recommending the vaccine for the Muslim community.

Suitability for the Jewish community

There is no specific information or position statement on the vaccine for the Jewish community. An update will be provided when information is available.