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Moon phases
Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
3 posters
Page 1 of 1
Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
Here is the MSDS for the Pfizer vaccine
https://safetydatasheets.pfizer.com/MyDocuments/DownloadSingleFile?content=344EF438-FD24-499F-8D64-5F3B7FEDC7DE_PDF
Section 11 makes interesting reading
Section 11: TOXICOLOGICAL INFORMATION
11.1. Information on toxicological effects
General Information: Toxicological properties have not been thoroughly investigated. The following information is
available for the individual ingredients. Known Clinical Effects: Based on clinical trials in humans, possible adverse effects following intravenous exposure
to this compound may include: muscle pain, abnormal redness of skin (erythema), fever, and sleep disturbances.
https://safetydatasheets.pfizer.com/MyDocuments/DownloadSingleFile?content=344EF438-FD24-499F-8D64-5F3B7FEDC7DE_PDF
Section 11 makes interesting reading
Section 11: TOXICOLOGICAL INFORMATION
11.1. Information on toxicological effects
General Information: Toxicological properties have not been thoroughly investigated. The following information is
available for the individual ingredients. Known Clinical Effects: Based on clinical trials in humans, possible adverse effects following intravenous exposure
to this compound may include: muscle pain, abnormal redness of skin (erythema), fever, and sleep disturbances.
jss64- news worthy
- Posts : 113
Join date : 2017-02-06
Re: Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
Thank you Jss, can't view it now but kind of you to add it...
urchinatheart- Moderator
- Posts : 200
Join date : 2017-02-05
Re: Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
[quote]
SAFETY DATA SHEETRevision date 16-Nov-2020 Version 1.02 Page 1 / 10Section 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product Name Pfizer-BioNTech COVID-19 Vaccine Product Code(s) PF00092 Synonyms PF-07302048 containing PF-07305885 (BNT162b2); CorVAC Containing PF-07305885 (BNT162b2) ; CoVVAC Containing PF-07305885 (BNT162b2); COVID Vaccine Containing PF-07305885 (BNT162b2); COVID-19 Vaccine Containing PF-07305885 (BNT162b2) Trade Name: Not applicable Compound Number PF-07302048 Item Code H000022941: H000023057 Chemical Family: Lipid Nanoparticles containing PF-07305885 (BNT162b2) and Lipids 1.2. Relevant identified uses of the substance or mixture and uses advised against Recommended Use Pharmaceutical product 1.3. Details of the supplier of the safety data sheet 1.4. Emergency telephone number Emergency Telephone Chemtrec 1-800-424-9300 International Chemtrec (24 hours):+1-703-527-3887 E-mail address pfizer-MSDS@pfizer.com Section 2: HAZARDS IDENTIFICATION 2.1. Classification of the substance or mixture Not classified as hazardous 2.2. Label elements Signal word Not classified Hazard statements Not classified in accordance with international standards for workplace safety. 2.3. Other hazards Other hazards An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Pfizer Inc 235 East 42nd Street New York, New York 10017 1-800-879-3477 Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161 _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 2 / 10Revision date 16-Nov-2020 Version 1.02 Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. Section 3: COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances NonHazardous Chemical Name EC No CAS No Weight-% Classification according to Regulation (EC) No. 1272/2008 [CLP] REACH Registration Number Water 231-791-2 7732-18-5 * Not Listed Sucrose 200-334-9 57-50-1 < 10 Not Listed SODIUM CHLORIDE 231-598-3 7647-14-5 < 10 Not Listed ALC-0315 Not Listed NOT ASSIGNED < 2 Not Listed Potassium phosphate 231-913-4 7778-77-0 < 1 Not Listed POTASSIUM CHLORIDE 231-211-8 7447-40-7 < 1 Not Listed PF-07305885 Not Listed NOT ASSIGNED <1 Not Listed PF-07302048 Not Listed NOT ASSIGNED < 1 Not Listed PEGA / ALC-0159 Not Listed NOT ASSIGNED < 1 Not Listed Disodium phosphate dihydrate Not Listed 10028-24-7 < 1 Not Listed Cholesterol 200-353-2 57-88-5 < 1 Not Listed 1,2-Distearoyl-sn-glycero-3-phosphocholine 212-440-2 816-94-4 < 1 Not Listed Full text of H- and EUH-phrases: see section 16 Additional information * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. Section 4: FIRST AID MEASURES 4.1. Description of first aid measures Inhalation Remove to fresh air. Seek immediate medical attention/advice. Eye contact Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician. Skin contact Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Ingestion Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. 4.2. Most important symptoms and effects, both acute and delayed Most important symptoms and No data available _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 3 / 10Revision date 16-Nov-2020 Version 1.02 effects 4.3. Indication of any immediate medical attention and special treatment needed Note to physicians None. Section 5: FIRE-FIGHTING MEASURES 5.1. Extinguishing media Suitable Extinguishing Media Dry chemical, CO2, alcohol-resistant foam or water spray. 5.2. Special hazards arising from the substance or mixture Specific hazards arising from the chemical Fine particles (such as mists) may fuel fires/explosions. Hazardous combustion products Formation of toxic gases is possible during heating or fire. 5.3. Advice for firefighters Special protective equipment for fire-fighters Firefighters should wear self-contained breathing apparatus and full firefighting turnout gear. Use personal protection equipment. Section 6: ACCIDENTAL RELEASE MEASURES 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. For emergency responders Use personal protection recommended in Section 8. 6.2. Environmental precautions Environmental precautions Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. 6.3. Methods and material for containment and cleaning up Methods for containment Prevent further leakage or spillage if safe to do so. Methods for cleaning up Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly. Prevention of secondary hazards Clean contaminated objects and areas thoroughly observing environmental regulations. 6.4. Reference to other sections Reference to other sections See section 8 for more information. See section 13 for more information. Section 7: HANDLING AND STORAGE 7.1. Precautions for safe handling _____________________________________________________________________________________________ PF00092 Advice on safe handlingRestrict access to work area. No open handling permitted. Minimize generating airborne mists and vapors. If solvent based liquid, ground and bond all bulk transfer equipment. Use appropriate engineering controls to maintain exposures below the B-OEB taking all applicable routes of exposure into consideration. A change area to facilitate 'good laboratory/manufacturing' decontamination practices is recommended. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 4 / 10Revision date 16-Nov-2020 Version 1.02 should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. General hygiene considerations Handle in accordance with good industrial hygiene and safety practice. 7.2. Conditions for safe storage, including any incompatibilities Storage Conditions Store at < -70 °C in properly labeled containers. Keep away from heat, sparks, and flames. 7.3. Specific end use(s) Specific use(s) Vaccine. Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control parameters Exposure LimitsRefer to available public information for specific member state Occupational Exposure Limits. Sucrose ACGIH TLV 10 mg/m3Bulgaria 10.0 mg/m3Estonia 10 mg/m3France 10 mg/m3Ireland 10 mg/m3STEL: 20 mg/m3Latvia 5 mg/m3Spain 10 mg/m3OSHA PEL 15 mg/m35 mg/m3(vacated) TWA: 15 mg/m3 total dust (vacated) TWA: 5 mg/m3 respirable fraction United Kingdom TWA: 10 mg/m3STEL: 20 mg/m3SODIUM CHLORIDE Latvia 5 mg/m3Russia MAC: 5 mg/m3Potassium phosphate Russia MAC: 10 mg/m3POTASSIUM CHLORIDE Bulgaria 5.0 mg/m3Latvia 5 mg/m3Russia MAC: 5 mg/m3Pfizer OEB Statement: The Biotherapeutic Occupational Exposure Band (B-OEB) is an acceptable daily intake (ADI) range, based on available hazard data with appropriate safety factors applied. Engineering control measures should be utilized to bring exposures into the relevant B-OEB; supplementary administrative controls and personal protective equipment are to be used to achieve exposure control to the bottom of the band. SODIUM CHLORIDE Pfizer Occupational Exposure Band (OEB): OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) POTASSIUM CHLORIDE Pfizer Occupational Exposure Band (OEB): OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) PF-07305885 Pfizer Occupational Exposure Band (OEB): B-OEB Default (control exposure to the range of 10 μg/day to <100 μg/day) PF-07302048 Pfizer Occupational Exposure B-OEB 5 (control exposure to <10 μg/day) _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 5 / 10Revision date 16-Nov-2020 Version 1.02 Band (OEB): 8.2. Exposure controls Engineering controls Engineering controls should be used as the primary means to control exposures. Use process containment, local exhaust ventilation, biosafety cabinet, or other engineering controls to maintain airborne levels within the B-OEB range. It is recommended that all large scale operations should be fully enclosed. Air recirculation is not recommended. Environmental exposure controls No information available. Personal protective equipment Contact your safety and health professional or safety equipment supplier for assistance in selecting the correct protective clothing/equipment based on an assessment of the workplace conditions, other chemicals used or present in the workplace and specific operational processes. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Eye/face protection Wear safety glasses as minimum protection (goggles recommended). (Eye protection must meet the standards in accordance with EN166, ANSI Z87.1 or international equivalent.). Hand protection Wear impervious disposable gloves (e.g. Nitrile, etc.) as minimum protection (double recommended). (Protective gloves must meet the standards in accordance with EN374, ASTM F1001 or international equivalent.). Skin and body protection Wear impervious disposable protective clothing when handling this compound. Full body protection is recommended (scale dependent). Wear impervious protective clothing when handling this compound. (Protective clothing must meet the standards in accordance with EN13982, ANSI 103 or international equivalent.). Respiratory protection Under normal conditions of use, if the applicable Biotherapeutic Occupational Exposure Band (B-OEB) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the B-OEB (e.g. particulate respirator with a full mask, P3 filter). (Respirators must meet the standards in accordance with EN136, EN143, ASTM F2704-10 or international equivalent.). General hygiene considerations Handle in accordance with good industrial hygiene and safety practice. Section 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties Physical state Liquid Color milky white Molecular formula (MF): Mixture Molecular weight Mixture Odor No data available. Odor threshold No data available Property Values pH 7.4 Melting point / freezing point No data available Boiling point / boiling range No data available Flash point No data available Evaporation rate No data available Flammability (solid, gas) No data available Flammability Limit in Air Upper flammability limit: No data available Lower flammability limit: _____________________________________________________________________________________________ PF00092 No data available
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 6 / 10Revision date 16-Nov-2020 Version 1.02 Explosive properties No data available Oxidizing properties No data available 9.2. Other information Liquid Density No data available Bulk density No data available Section 10: STABILITY AND REACTIVITY 10.1. Reactivity Reactivity No data available. 10.2. Chemical stability Stability Stable under normal conditions. Explosion data Sensitivity to Mechanical Impact No data available. Sensitivity to Static Discharge No data available. 10.3. Possibility of hazardous reactions Possibility of hazardous reactions No information available. 10.4. Conditions to avoid Conditions to avoid Fine particles (such as mists) may fuel fires/explosions. As a precautionary measure, keep away from heat sources and electrostatic discharge. 10.5. Incompatible materials Incompatible materials As a precautionary measure, keep away from strong oxidizers. 10.6. Hazardous decomposition products Hazardous decomposition products No data available. Section 11: TOXICOLOGICAL INFORMATION 11.1. Information on toxicological effects General Information: Toxicological properties have not been thoroughly investigated. The following information is available for the individual ingredients. Known Clinical Effects: Based on clinical trials in humans, possible adverse effects following intravenous exposure to this compound may include: muscle pain, abnormal redness of skin (erythema), fever, and sleep disturbances. Acute Toxicity: (Species, Route, End Point, Dose) Sucrose Rat Oral LD 50 29,700 mg/kg SODIUM CHLORIDE Rat Sub-tenon injection (eye) LC50/1hr > 42 g/m3 Rat Oral LD 50 3 g/kg Vapor pressure No data available Vapor density No data available Relative density No data available Water solubility No data available Solubility(ies) No data available Autoignition temperature No data available Decomposition temperature No data available Kinematic viscosity No data available Dynamic viscosity _____________________________________________________________________________________________ PF00092 No data available
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 7 / 10Revision date 16-Nov-2020 Version 1.02 Mouse Oral LD 50 4 g/kg Rabbit Dermal LD 50 > 10 g/kg POTASSIUM CHLORIDE Rat Oral LD50 2600 mg/kg Potassium phosphate Rat Oral LD50 3200 mg/kg Rabbit Dermal LC50 > 4640 mg/kg Chemical Name Oral LD50 Dermal LD50 Inhalation LC50 Water > 90 mL/kg ( Rat ) - - Sucrose = 29700 mg/kg ( Rat ) - - SODIUM CHLORIDE = 3 g/kg ( Rat ) - > 42 g/m3 ( Rat ) 1 h Potassium phosphate = 3200 mg/kg ( Rat ) - - POTASSIUM CHLORIDE = 2600 mg/kg ( Rat ) - - Irritation / Sensitization: (Study Type, Species, Severity) SODIUM CHLORIDE Skin Irritation Rabbit Mild Eye Irritation Rabbit Mild POTASSIUM CHLORIDE Eye Irritation Rabbit Mild Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) PF-07302048 4 Week(s) Rat Intramuscular * 10 μg LOAEL Skin, Blood forming organs, Blood, Skeletal muscle, Lymphoid tissue, Spleen Repeated Dose Toxicity Comments: PF-07302048: * Doses were administered once a week. Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Potassium phosphate Reproductive & Fertility Rat No route specified 282 mg/kg/day NOAEL No evidence of impaired fertility or harm to the fetus Reproductive & Fertility Mouse No route specified 320 mg/kg/day NOAEL No evidence of impaired fertility or harm to the fetus Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Potassium phosphate Bacterial Mutagenicity (Ames) Salmonella Negative Carcinogenicity See below Cholesterol IARC Group 3 (Not Classifiable) Section 12: ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided. 12.1. Toxicity Aquatic Toxicity: (Species, Method, End Point, Duration, Result) POTASSIUM CHLORIDE _____________________________________________________________________________________________ PF00092 Gambusia affinis (Mosquitofish) LC50 96 hours 920 mg/l
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 8 / 10Revision date 16-Nov-2020 Version 1.02 Lepomis macrochirus (Bluegill Sunfish) LC50 96 hours 2010 mg/L Daphnia Magna (Water Flea) EC50 48 hours 825 mg/l Scenedesmus subspicatus (Green Alga) EC50 72 Hours 2500 mg/L 12.2. Persistence and degradability Persistence and degradability No information available. 12.3. Bioaccumulative potential Bioaccumulation No information available. 12.4. Mobility in soil Mobility in soil No information available. 12.5. Results of PBT and vPvB assessment PBT and vPvB assessment No information available. Chemical Name PBT and vPvB assessment SODIUM CHLORIDE The substance is not PBT / vPvB PBT assessment does not apply Potassium phosphate The substance is not PBT / vPvB PBT assessment does not apply POTASSIUM CHLORIDE The substance is not PBT / vPvB PBT assessment does not apply Cholesterol The substance is not PBT / vPvB 12.6. Other adverse effects Other adverse effects No information available. Section 13: DISPOSAL CONSIDERATIONS 13.1. Waste treatment methods Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater. Section 14: TRANSPORT INFORMATION The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 9 / 10Revision date 16-Nov-2020 Version 1.02 Section 15: REGULATORY INFORMATION 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture Water CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-791-2 AICS Present Sucrose CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 200-334-9 AICS Present SODIUM CHLORIDE CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-598-3 AICS Present ALC-0315 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed Potassium phosphate CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-913-4 AICS Present POTASSIUM CHLORIDE CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-211-8 AICS Present Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) Schedule 4 PF-07305885 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed PF-07302048 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed PEGA / ALC-0159 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed Disodium phosphate dihydrate CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed AICS Present Standard for Uniform Scheduling of Medicines and Schedule 5 _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 10 / 10Revision date 16-Nov-2020 Version 1.02 Poisons (SUSMP) Cholesterol CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 200-353-2 AICS Present Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) Schedule 4 1,2-Distearoyl-sn-glycero-3-phosphocholine CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS 212-440-2 15.2. Chemical safety assessment Chemical Safety Report No information available Section 16: OTHER INFORMATION Key or legend to abbreviations and acronyms used in the safety data sheetData Sources: Pfizer proprietary drug development information. Publicly available toxicity information. Reason for revision Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. Revision date 16-Nov-2020 Prepared By Product Stewardship Hazard Communication Pfizer Global Environment, Health, and Safety Operations Pfizer Inc believes that the information contained in this Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. _____________________________________________________________________________________________ PF00092
[/quote]
SAFETY DATA SHEETRevision date 16-Nov-2020 Version 1.02 Page 1 / 10Section 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product Name Pfizer-BioNTech COVID-19 Vaccine Product Code(s) PF00092 Synonyms PF-07302048 containing PF-07305885 (BNT162b2); CorVAC Containing PF-07305885 (BNT162b2) ; CoVVAC Containing PF-07305885 (BNT162b2); COVID Vaccine Containing PF-07305885 (BNT162b2); COVID-19 Vaccine Containing PF-07305885 (BNT162b2) Trade Name: Not applicable Compound Number PF-07302048 Item Code H000022941: H000023057 Chemical Family: Lipid Nanoparticles containing PF-07305885 (BNT162b2) and Lipids 1.2. Relevant identified uses of the substance or mixture and uses advised against Recommended Use Pharmaceutical product 1.3. Details of the supplier of the safety data sheet 1.4. Emergency telephone number Emergency Telephone Chemtrec 1-800-424-9300 International Chemtrec (24 hours):+1-703-527-3887 E-mail address pfizer-MSDS@pfizer.com Section 2: HAZARDS IDENTIFICATION 2.1. Classification of the substance or mixture Not classified as hazardous 2.2. Label elements Signal word Not classified Hazard statements Not classified in accordance with international standards for workplace safety. 2.3. Other hazards Other hazards An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Pfizer Inc 235 East 42nd Street New York, New York 10017 1-800-879-3477 Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161 _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 2 / 10Revision date 16-Nov-2020 Version 1.02 Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. Section 3: COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances NonHazardous Chemical Name EC No CAS No Weight-% Classification according to Regulation (EC) No. 1272/2008 [CLP] REACH Registration Number Water 231-791-2 7732-18-5 * Not Listed Sucrose 200-334-9 57-50-1 < 10 Not Listed SODIUM CHLORIDE 231-598-3 7647-14-5 < 10 Not Listed ALC-0315 Not Listed NOT ASSIGNED < 2 Not Listed Potassium phosphate 231-913-4 7778-77-0 < 1 Not Listed POTASSIUM CHLORIDE 231-211-8 7447-40-7 < 1 Not Listed PF-07305885 Not Listed NOT ASSIGNED <1 Not Listed PF-07302048 Not Listed NOT ASSIGNED < 1 Not Listed PEGA / ALC-0159 Not Listed NOT ASSIGNED < 1 Not Listed Disodium phosphate dihydrate Not Listed 10028-24-7 < 1 Not Listed Cholesterol 200-353-2 57-88-5 < 1 Not Listed 1,2-Distearoyl-sn-glycero-3-phosphocholine 212-440-2 816-94-4 < 1 Not Listed Full text of H- and EUH-phrases: see section 16 Additional information * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. Section 4: FIRST AID MEASURES 4.1. Description of first aid measures Inhalation Remove to fresh air. Seek immediate medical attention/advice. Eye contact Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician. Skin contact Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Ingestion Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. 4.2. Most important symptoms and effects, both acute and delayed Most important symptoms and No data available _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 3 / 10Revision date 16-Nov-2020 Version 1.02 effects 4.3. Indication of any immediate medical attention and special treatment needed Note to physicians None. Section 5: FIRE-FIGHTING MEASURES 5.1. Extinguishing media Suitable Extinguishing Media Dry chemical, CO2, alcohol-resistant foam or water spray. 5.2. Special hazards arising from the substance or mixture Specific hazards arising from the chemical Fine particles (such as mists) may fuel fires/explosions. Hazardous combustion products Formation of toxic gases is possible during heating or fire. 5.3. Advice for firefighters Special protective equipment for fire-fighters Firefighters should wear self-contained breathing apparatus and full firefighting turnout gear. Use personal protection equipment. Section 6: ACCIDENTAL RELEASE MEASURES 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. For emergency responders Use personal protection recommended in Section 8. 6.2. Environmental precautions Environmental precautions Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. 6.3. Methods and material for containment and cleaning up Methods for containment Prevent further leakage or spillage if safe to do so. Methods for cleaning up Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly. Prevention of secondary hazards Clean contaminated objects and areas thoroughly observing environmental regulations. 6.4. Reference to other sections Reference to other sections See section 8 for more information. See section 13 for more information. Section 7: HANDLING AND STORAGE 7.1. Precautions for safe handling _____________________________________________________________________________________________ PF00092 Advice on safe handlingRestrict access to work area. No open handling permitted. Minimize generating airborne mists and vapors. If solvent based liquid, ground and bond all bulk transfer equipment. Use appropriate engineering controls to maintain exposures below the B-OEB taking all applicable routes of exposure into consideration. A change area to facilitate 'good laboratory/manufacturing' decontamination practices is recommended. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 4 / 10Revision date 16-Nov-2020 Version 1.02 should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. General hygiene considerations Handle in accordance with good industrial hygiene and safety practice. 7.2. Conditions for safe storage, including any incompatibilities Storage Conditions Store at < -70 °C in properly labeled containers. Keep away from heat, sparks, and flames. 7.3. Specific end use(s) Specific use(s) Vaccine. Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control parameters Exposure LimitsRefer to available public information for specific member state Occupational Exposure Limits. Sucrose ACGIH TLV 10 mg/m3Bulgaria 10.0 mg/m3Estonia 10 mg/m3France 10 mg/m3Ireland 10 mg/m3STEL: 20 mg/m3Latvia 5 mg/m3Spain 10 mg/m3OSHA PEL 15 mg/m35 mg/m3(vacated) TWA: 15 mg/m3 total dust (vacated) TWA: 5 mg/m3 respirable fraction United Kingdom TWA: 10 mg/m3STEL: 20 mg/m3SODIUM CHLORIDE Latvia 5 mg/m3Russia MAC: 5 mg/m3Potassium phosphate Russia MAC: 10 mg/m3POTASSIUM CHLORIDE Bulgaria 5.0 mg/m3Latvia 5 mg/m3Russia MAC: 5 mg/m3Pfizer OEB Statement: The Biotherapeutic Occupational Exposure Band (B-OEB) is an acceptable daily intake (ADI) range, based on available hazard data with appropriate safety factors applied. Engineering control measures should be utilized to bring exposures into the relevant B-OEB; supplementary administrative controls and personal protective equipment are to be used to achieve exposure control to the bottom of the band. SODIUM CHLORIDE Pfizer Occupational Exposure Band (OEB): OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) POTASSIUM CHLORIDE Pfizer Occupational Exposure Band (OEB): OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) PF-07305885 Pfizer Occupational Exposure Band (OEB): B-OEB Default (control exposure to the range of 10 μg/day to <100 μg/day) PF-07302048 Pfizer Occupational Exposure B-OEB 5 (control exposure to <10 μg/day) _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 5 / 10Revision date 16-Nov-2020 Version 1.02 Band (OEB): 8.2. Exposure controls Engineering controls Engineering controls should be used as the primary means to control exposures. Use process containment, local exhaust ventilation, biosafety cabinet, or other engineering controls to maintain airborne levels within the B-OEB range. It is recommended that all large scale operations should be fully enclosed. Air recirculation is not recommended. Environmental exposure controls No information available. Personal protective equipment Contact your safety and health professional or safety equipment supplier for assistance in selecting the correct protective clothing/equipment based on an assessment of the workplace conditions, other chemicals used or present in the workplace and specific operational processes. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Eye/face protection Wear safety glasses as minimum protection (goggles recommended). (Eye protection must meet the standards in accordance with EN166, ANSI Z87.1 or international equivalent.). Hand protection Wear impervious disposable gloves (e.g. Nitrile, etc.) as minimum protection (double recommended). (Protective gloves must meet the standards in accordance with EN374, ASTM F1001 or international equivalent.). Skin and body protection Wear impervious disposable protective clothing when handling this compound. Full body protection is recommended (scale dependent). Wear impervious protective clothing when handling this compound. (Protective clothing must meet the standards in accordance with EN13982, ANSI 103 or international equivalent.). Respiratory protection Under normal conditions of use, if the applicable Biotherapeutic Occupational Exposure Band (B-OEB) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the B-OEB (e.g. particulate respirator with a full mask, P3 filter). (Respirators must meet the standards in accordance with EN136, EN143, ASTM F2704-10 or international equivalent.). General hygiene considerations Handle in accordance with good industrial hygiene and safety practice. Section 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties Physical state Liquid Color milky white Molecular formula (MF): Mixture Molecular weight Mixture Odor No data available. Odor threshold No data available Property Values pH 7.4 Melting point / freezing point No data available Boiling point / boiling range No data available Flash point No data available Evaporation rate No data available Flammability (solid, gas) No data available Flammability Limit in Air Upper flammability limit: No data available Lower flammability limit: _____________________________________________________________________________________________ PF00092 No data available
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 6 / 10Revision date 16-Nov-2020 Version 1.02 Explosive properties No data available Oxidizing properties No data available 9.2. Other information Liquid Density No data available Bulk density No data available Section 10: STABILITY AND REACTIVITY 10.1. Reactivity Reactivity No data available. 10.2. Chemical stability Stability Stable under normal conditions. Explosion data Sensitivity to Mechanical Impact No data available. Sensitivity to Static Discharge No data available. 10.3. Possibility of hazardous reactions Possibility of hazardous reactions No information available. 10.4. Conditions to avoid Conditions to avoid Fine particles (such as mists) may fuel fires/explosions. As a precautionary measure, keep away from heat sources and electrostatic discharge. 10.5. Incompatible materials Incompatible materials As a precautionary measure, keep away from strong oxidizers. 10.6. Hazardous decomposition products Hazardous decomposition products No data available. Section 11: TOXICOLOGICAL INFORMATION 11.1. Information on toxicological effects General Information: Toxicological properties have not been thoroughly investigated. The following information is available for the individual ingredients. Known Clinical Effects: Based on clinical trials in humans, possible adverse effects following intravenous exposure to this compound may include: muscle pain, abnormal redness of skin (erythema), fever, and sleep disturbances. Acute Toxicity: (Species, Route, End Point, Dose) Sucrose Rat Oral LD 50 29,700 mg/kg SODIUM CHLORIDE Rat Sub-tenon injection (eye) LC50/1hr > 42 g/m3 Rat Oral LD 50 3 g/kg Vapor pressure No data available Vapor density No data available Relative density No data available Water solubility No data available Solubility(ies) No data available Autoignition temperature No data available Decomposition temperature No data available Kinematic viscosity No data available Dynamic viscosity _____________________________________________________________________________________________ PF00092 No data available
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 7 / 10Revision date 16-Nov-2020 Version 1.02 Mouse Oral LD 50 4 g/kg Rabbit Dermal LD 50 > 10 g/kg POTASSIUM CHLORIDE Rat Oral LD50 2600 mg/kg Potassium phosphate Rat Oral LD50 3200 mg/kg Rabbit Dermal LC50 > 4640 mg/kg Chemical Name Oral LD50 Dermal LD50 Inhalation LC50 Water > 90 mL/kg ( Rat ) - - Sucrose = 29700 mg/kg ( Rat ) - - SODIUM CHLORIDE = 3 g/kg ( Rat ) - > 42 g/m3 ( Rat ) 1 h Potassium phosphate = 3200 mg/kg ( Rat ) - - POTASSIUM CHLORIDE = 2600 mg/kg ( Rat ) - - Irritation / Sensitization: (Study Type, Species, Severity) SODIUM CHLORIDE Skin Irritation Rabbit Mild Eye Irritation Rabbit Mild POTASSIUM CHLORIDE Eye Irritation Rabbit Mild Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) PF-07302048 4 Week(s) Rat Intramuscular * 10 μg LOAEL Skin, Blood forming organs, Blood, Skeletal muscle, Lymphoid tissue, Spleen Repeated Dose Toxicity Comments: PF-07302048: * Doses were administered once a week. Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Potassium phosphate Reproductive & Fertility Rat No route specified 282 mg/kg/day NOAEL No evidence of impaired fertility or harm to the fetus Reproductive & Fertility Mouse No route specified 320 mg/kg/day NOAEL No evidence of impaired fertility or harm to the fetus Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Potassium phosphate Bacterial Mutagenicity (Ames) Salmonella Negative Carcinogenicity See below Cholesterol IARC Group 3 (Not Classifiable) Section 12: ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided. 12.1. Toxicity Aquatic Toxicity: (Species, Method, End Point, Duration, Result) POTASSIUM CHLORIDE _____________________________________________________________________________________________ PF00092 Gambusia affinis (Mosquitofish) LC50 96 hours 920 mg/l
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 8 / 10Revision date 16-Nov-2020 Version 1.02 Lepomis macrochirus (Bluegill Sunfish) LC50 96 hours 2010 mg/L Daphnia Magna (Water Flea) EC50 48 hours 825 mg/l Scenedesmus subspicatus (Green Alga) EC50 72 Hours 2500 mg/L 12.2. Persistence and degradability Persistence and degradability No information available. 12.3. Bioaccumulative potential Bioaccumulation No information available. 12.4. Mobility in soil Mobility in soil No information available. 12.5. Results of PBT and vPvB assessment PBT and vPvB assessment No information available. Chemical Name PBT and vPvB assessment SODIUM CHLORIDE The substance is not PBT / vPvB PBT assessment does not apply Potassium phosphate The substance is not PBT / vPvB PBT assessment does not apply POTASSIUM CHLORIDE The substance is not PBT / vPvB PBT assessment does not apply Cholesterol The substance is not PBT / vPvB 12.6. Other adverse effects Other adverse effects No information available. Section 13: DISPOSAL CONSIDERATIONS 13.1. Waste treatment methods Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater. Section 14: TRANSPORT INFORMATION The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 9 / 10Revision date 16-Nov-2020 Version 1.02 Section 15: REGULATORY INFORMATION 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture Water CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-791-2 AICS Present Sucrose CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 200-334-9 AICS Present SODIUM CHLORIDE CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-598-3 AICS Present ALC-0315 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed Potassium phosphate CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-913-4 AICS Present POTASSIUM CHLORIDE CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 231-211-8 AICS Present Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) Schedule 4 PF-07305885 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed PF-07302048 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed PEGA / ALC-0159 CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed Disodium phosphate dihydrate CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS Not Listed AICS Present Standard for Uniform Scheduling of Medicines and Schedule 5 _____________________________________________________________________________________________ PF00092
SAFETY DATA SHEET _____________________________________________________________________________________________ Product Name Pfizer-BioNTech COVID-19 Vaccine Page 10 / 10Revision date 16-Nov-2020 Version 1.02 Poisons (SUSMP) Cholesterol CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed TSCA Present EINECS 200-353-2 AICS Present Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) Schedule 4 1,2-Distearoyl-sn-glycero-3-phosphocholine CERCLA/SARA Section 313 de minimus % Not Listed California Proposition 65 Not Listed EINECS 212-440-2 15.2. Chemical safety assessment Chemical Safety Report No information available Section 16: OTHER INFORMATION Key or legend to abbreviations and acronyms used in the safety data sheetData Sources: Pfizer proprietary drug development information. Publicly available toxicity information. Reason for revision Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. Revision date 16-Nov-2020 Prepared By Product Stewardship Hazard Communication Pfizer Global Environment, Health, and Safety Operations Pfizer Inc believes that the information contained in this Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. _____________________________________________________________________________________________ PF00092
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Last edited by Lopsum on Tue Dec 15, 2020 11:07 am; edited 1 time in total (Reason for editing : to disable bbcode and smileys)
Re: Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
That's strange. I just went on the link and it appeared fine
jss64- news worthy
- Posts : 113
Join date : 2017-02-06
Re: Pfizer-BioNTech COVID-19 Vaccine Safety Data Sheet
Thank you, have got the info I wanted now.
urchinatheart- Moderator
- Posts : 200
Join date : 2017-02-05
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