People with allergies to any of the ingredients of the vaccine are currently cautioned against receiving it. This caution is already noted in the Canadian Product Monograph (prescribing information) for the Pfizer-BioNTech COVID-19 vaccine. The vaccine’s ingredients are as follows:
- Medicinal ingredient:
- mRNA
- Non-medicinal ingredients:
- 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
- dibasic sodium phosphate dihydrate
- monobasic potassium phosphate
- potassium chloride
- sodium chloride
- sucrose
- water for injection
Ribonucleic Acid (RNA) 
Ribonucleic acid (RNA) is a molecule similar to DNA. Unlike DNA, RNA is single-stranded. An RNA strand has a backbone made of alternating sugar (ribose) and phosphate groups. Attached to each sugar is one of four bases--adenine (A), uracil (U), cytosine (C), or guanine (G). Different types of RNA exist in the cell: messenger RNA (mRNA), ribosomal RNA (rRNA), and transfer RNA (tRNA). More recently, some small RNAs have been found to be involved in regulating gene expression.
Illustration
Narration
RNA, or ribonucleic acid, is a nucleic acid that is similar in structure to DNA but different in subtle ways. The cell uses RNA for a number of different tasks, one of which is called messenger RNA, or mRNA. And that is the nucleic acid information molecule that transfers information from the genome into proteins by translation. Another form of RNA is tRNA, or transfer RNA, and these are non-protein encoding RNA molecules that physically carry amino acids to the translation site that allows them to be assembled into chains of proteins in the process of translation.
Leslie G. Biesecker, M.D.Messenger RNA (mRNA) is a single-stranded RNA molecule that is complementary to one of the DNA strands of a gene. The mRNA is an RNA version of the gene that leaves the cell nucleus and moves to the cytoplasm where proteins are made. During protein synthesis, an organelle called a ribosome moves along the mRNA, reads its base sequence, and uses the genetic code to translate each three-base triplet, or codon, into its corresponding amino acid.
Illustration
Narration
Messenger RNAs, also known as mRNA, are one of the types of RNA that are found in the cell. This particular one, like most RNAs, are made in the nucleus and then exported to the cytoplasm where the translation machinery, the machinery that actually makes proteins, binds to these mRNA molecules and reads the code on the mRNA to make a specific protein. So in general, one gene, the DNA for one gene, can be transcribed into an mRNA molecule that will end up making one specific protein.
Lawrence C. Brody, Ph.D.
Excipients information for Pfizer-BioNTech COVID-19 Vaccine
Helen Davis, UKMi, Director, North West Medicines Information Centre ·
Published
15 December 2020
Topics: Allergy and immunology · Excipients · Pfizer-BioNTech Vaccine:
Answers to Questions
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 10 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. See also Advising individuals with allergies on their suitability for Pfizer-BioNTech COVID-19 Vaccine.
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.
Click》》
https://www.sps.nhs.uk/articles/excipients-information-for-pfizer-biontech-covid-19-vaccine/ 《《click to view source.
No comments:
Post a Comment