All information these cookies collect is aggregated and therefore anonymous. Considering that the well-established strategies reported in ICH or WHO guidelines are not always broadly applicable to vaccines, this article represents an important source of information for vaccine researchers and manufacturers, setting the grounds for further discussion within the vaccine industry and with regulators. Sanofi Pasteur: 75D30121D10190: 49281-0421-50: 10 pack - 1 dose syringe: $14.223: $18.84: Influenza and D.C. are Sanofi employees and may hold shares and/or stock options in the company. |N;Cu4p40et050u04t0H4u0pt0ht0ut0u40t $u3F1@y{ $}L]?axnGuoX$X1nAt0[4P2\MQ ~[}
Agreement to develop and commercialize nirsevimab for the prevention of Respiratory Syncytial Virus (RSV) disease in all infants. vaccine containing tetanus toxoid, the risk for Guillain-Barr syndrome . Store in original package. .5m7!K #|V0ZyS}nEv. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Prevnar 13 is stable at temperatures up to 25C (77F) for 4 days. doi: 10.1016/j.tca.2014.01.005. It is provided for information only. ", "We even get a sizable rebate at the end of the year. Accessibility Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Sanofi Pasteur 8008222463 ActHib Adacel Daptacel PMC The following adult, adolescent, pediatric and travel vaccines are available: Vaxelis (DTaP-IPV-Hib-HepB) Adacel (Tdap)Pentacel (DTaP-IPV-HIB)Daptacel (DTaP)Tripedia (DTaP)ActHIB (HIB)Tubersol 5 TUMenQuadfi (A,C,Y,W)IPOL (IPV)Fluzone (Fluzone Influenza Vaccine TIV, Fluzone Quadrivalent (QIV), Fluzone High Dose, Fluzone Intradermal)YF-VAX (YF)Typhim Vi (ViCPS)Imogam (RIG)Imovax (HDCV)TENIVAC (TD)TheraCys (BCG). Investigator Sponsored Studies and Externally Sponsored Collaboration, Access to Quality Healthcare Sanofi Global Health, Contributing to the eradication, elimination and control of some infectious diseases, Serving the needs of patients with non-communicable diseases, Development opportunity: how Sanofi empowers you. This third-party website is neither owned nor controlled by Pfizer, and Pfizer does not endorse and is not responsible for the content or services of this site. Non-live vaccines should generally be repeated as soon as possible. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. As a result of the global effort to eradicate the disease, more than 16 million people have been saved from paralysis. Did You See Fluzone HD & Flublok on T.V. Poliomyelitis Fact sheet. Vaccines - Sanofi U.S. PRODUCTS & RESOURCES Vaccines This information is intended for U.S. residents. Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Abbreviations: DEN4CYD = dengue vaccine; DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; HepA = hepatitis A; HepB = hepatitis B; Hib = Haemophilus influenzae type b; HPV = human papillomavirus; IIV = inactivated influenza vaccine; IPV = inactivated poliovirus; LAIV = live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MenB = Serogroup B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, and varicella; MPSV4 = quadrivalent meningococcal polysaccharide vaccine; PCV13 = pneumococcal conjugate vaccine; PPSV23= pneumococcal polysaccharide vaccine; PRP-OMP = polyribosylribitol phosphate-meningococcal outer membrane protein conjugate; PRP-T = polyribosylribitol phosphate polysaccharide conjugated to a tetanus toxoid; PRP-T Hib = polyribosylphosphate tetanus-toxoid conjugate Hib vaccine; PRP-T Hib-MenCY = polyribosylphosphate-tetanus-toxoid Hib vaccine with a bivalent Meningococcal vaccine; RV = rotavirus; RV1 = live, attenuated monovalent rotavirus vaccine; RV5 = live, reassortment pentavalent rotavirus vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis. Sanofi develops, manufactures and distributes vaccines that respect regulatory requirements and our company's values. Pfizer Canada accepts no responsibility for the content of linked sites. Monitoring of Vaccine Wastage at Country Level. .RQRW0de HHS Vulnerability Disclosure, Help Vaccine transport between the storage site and the administration clinic is discouraged unless the cold chain is maintained, and vaccine transport by the patient is particularly discouraged. An accelerated stability test procedure for lyophilized measles vaccines. doi: 10.1016/j.ejpb.2018.01.005. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Download the temperature report from the digital data logger. Int J Pharm. Non-live lyophilized vaccines generally do not need to be frozen, but lyophilized varicella-containing vaccines that are recommended to be stored frozen lose potency when exposed to higher temperatures because the viruses degrade more quickly at storage temperatures that are warmer than recommended (Table 7-1). 169199. C.C., T.P. WHO. Thank you for taking the time to confirm your preferences. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com. Before doi: 10.1016/S0092-1157(81)80022-4. [Online]2008 [Cited January 2018]. Last reviewed January 2018. You can review and change the way we collect information below. It is contracted by drinking or eating the Salmonella typhi bacterium in contaminated food or water. For example, after reconstitution, MMR vaccine should be kept at refrigerator temperature and must be administered within 8 hours. These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions. For general recommendations and guidance, see Vaccine Storage and Handling. Would you like to proceed? Treasure Island (FL): StatPearls Publishing; 2022 Jan. J.W. endstream
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With investments in our new mRNA Center of Excellence, our rich and exciting pipeline will continue to gain momentum as we continue to increase our focus on first- and best-in-class science. Proper vaccine storage and handling practices play an important role in protecting individuals and communities from vaccine-preventable diseases. -. 2022 Feb 8;14(2):375. doi: 10.3390/pharmaceutics14020375. If you wish to continue to this external website, click Proceed. 7 Sanofi-Pasteur, Bioprocess R&D Department, 69280 Marcy l'Etoile, France. The virus is harvested from infected MRC-5 human diploid cells, concentrated by ultrafiltration and inactivated by beta-propiolactone. Stability Modeling in QbD: Accelerating Formulation Development and Predicting Shelf Life of Products; pp. Thermochim. HlSn0+(5MJE4S E
nFENm2.'>v9;;]6+p\=B4o Vaccines licensed for refrigerator storage should be stored at 2C-8C (36F-46F). . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). This is particularly relevant for vaccines, with numerous vaccines strictly requiring cold storage to remain stable. 2022 May 18. hbbd``b`k3 $@i#N}@
The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. According to the WHO, as long as a single child remains infected, children in all countries are at risk of contracting polio. Your Health; Vaccines ; Science & Innovation. TYPHIM Vi , Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain. Consultation with CDC is available when necessary. government site. All information these cookies collect is aggregated and therefore anonymous. Store diphtheria, tetanus, and pertussis vaccines in the original packaging. If thats you, lets start a conversation. Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil France. #$*j m 0%^p7?HC10xALTdcJ. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Federal government websites often end in .gov or .mil. The site is secure. See Vaccine Storage and Handling Toolkitfor additional information about expiration dates. Proper vaccine storage and handling practices play a very important role in protecting individuals and communities from vaccine-preventable diseases. J. Biol. STN#: 125145Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccineTradename: PentacelManufacturer: Sanofi Pasteur LimitedIndication: An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Emergency Use Authorization for Vaccines Explained, Package Insert Pentacel - (inactivated poliovirus component grown in MRC-5 cells), Package Insert Pentacel - (inactivated poliovirus component grown in Vero cells), October 21, 2022 Approval Letter - Pentacel, February 17, 2021 Approval Letter - Pentacel, December 19, 2019 Approval Letter - Pentacel, Approval History, Letters, Reviews, and Related Documents - Pentacel, Supporting Documents older than three years - Pentacel, For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to. (:reu$YT)D>$doZn "Avoid any doubt for the end-user of vaccine compliance at time of administration". If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. . ", "In order for private practice pediatricians to survive these difficult times we need programs like MPPG to help us lower our overhead. Centers for Disease Control and Prevention. Store diphtheria, tetanus, and pertussis vaccines refrigerated between 2C and 8C (36F and 46F). Links to other sites are provided as a convenience to the viewer, and should not be taken as an endorsement of the sites or an association with their owners. The company offers the broadest range of Sanofi Pasteur vaccines in the world, providing protection against 20 bacterial and viral diseases and distributes more than 1.6 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. if vaccine has experienced previous excursion/ incident. Let Sanofi Pasteur help you reach your patients with WellConnect. and L.C. CDC twenty four seven. J. Pharm. Doses of expired vaccines that are administered inadvertently generally should not be counted as valid and should be repeated. and MPPG. The https:// ensures that you are connecting to the Please enable it to take advantage of the complete set of features! Accurate prediction of vaccine stability under real storage conditions and during temperature excursions Due to their thermosensitivity, most vaccines must be kept refrigerated from production to use. COVAX; accelerated predictive stability; advanced kinetic modeling. Real time and accelerated stability studies of Tetanus toxoid manufactured in public sector facilities of Pakistan. In order to provide you with relevant and meaningful content we need to know more about you. A plan should be developed ahead of time to address various types of emergencies that might require removal of vaccine from the original storage unit. Find out how our vaccines are made Download the infographic "Key steps in the production of a vaccine" These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions. They help us to know which pages are the most and least popular and see how visitors move around the site. Unable to load your collection due to an error, Unable to load your delegates due to an error, Stability data points used to build models (full circles) at +5 C (blue), +25 C (red), +37 C (green), and +45 C (pink) (, Antigenicity predictions based on vaccine 6 months data points (full circles) at +5 C (blue), +25 C (red), and +37 C (green) for 19 batches. The .gov means its official. Cumulative multiple temperature excursions between 8C and 25C are permitted, as long as the total time does not exceed 4 days (96 hours). Purchase Sanofi Pasteur products directly from VaccineShoppe.com or by calling (800) VACCINE (800-822-2463). Fact sheet The power of vaccines: still not fully utilized. Thank you for taking the time to confirm your preferences. 1981;9:185194. On This Page Temperature Storage Reconstitution Disposal Antigenicity predictions at +5 C are displayed as blue lines based on n, Antigenicity predictions of vaccine using a classical linear regression (left column) and non-linear regression (i.e., advanced kinetics, right column) of 6 months data points (full circles). are employed by the GSK group of companies. Sanofi assumes no responsibility for the information presented on this website. When stability evaluation is exclusively based on real-time data, it may represent a bottleneck for rapid and effective vaccine access. Updated March 2019. WHO. Fact sheet No. . Data at +5 C (blue) were used for linear regression (panel (, Vaccine antigenicity predicted from the best kinetic model during temperature excursions outside the cold-chain. Your privacy is important to us These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Allison L.M.C., Mann G.F., Perkins F.T., Zuckerman A.J. Liquid vaccines containing an aluminum adjuvant permanently lose potency when exposed to freezing temperatures. H|y\Go91Q#.1xD5QBDE%^BVx *ORc2`c5fC6|^UNhd1[',~7 Labeling the space where the vaccine is stored with name, age indications, and other information unique to the vaccine can help prevent vaccine administration errors. Specify a filename that includes VFC PIN, storage unit ID, . Vaccines licensed for refrigerator storage should be stored at 2C-8C (36F-46F). Both powder and diluent should be stored at 35F-46F. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. -. Manufacturer: Sanofi Pasteur, Inc (for Fluzone High-Dose and Fluzone Intradermal only) Indication: Fluzone is indicated for active immunization of persons 6 months of age and older against. Milbank Q. This article reports a cross-company perspective on stability modeling for vaccines. The .gov means its official.Federal government websites often end in .gov or .mil. Vaccines are at the center of our strategy as a key driver of growth led by an accelerated R&D engine. Can be refrigerated or stored at room temperature. Eur. Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800 . WHO. Epub 2021 Mar 2. When vaccines are removed from storage, clinicians and other health-care providers should note whether an expiration window exists for vaccine stored at room temperature or at an intermediate temperature. To successfully carry out global immunization programs, ensuring the stability of vaccines is crucial. Recommendations in the product package inserts, including methods for reconstitution of the vaccine, should be followed carefully. Vaccines should continue to be stored at recommended temperatures immediately upon receipt until use. This content is intended for U.S. Healthcare Professionals. 2023 Pfizer Inc. All rights reserved. Saving Lives, Protecting People, Vaccine Recommendations and Guidelines of the ACIP, National Center for Immunization and Respiratory Diseases, Comprehensive Recommendations and Guidelines, Preventing and Managing Adverse Reactions, Vaccine Recommendations for Emergency Situations, CDC's International Travelers Yellow Book, Clinical Travel Notices, Updates, and Vaccine Shortages, U.S. Department of Health & Human Services, Diphtheria-tetanus-containing vaccines (DT, Td) or pertussis-containing vaccines (DTaP, Tdap). %PDF-1.7
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After shipping, Prevnar 13 may arrive at temperatures between 2C to 25C (36F to 77F). Temperature Stability Calculator | Pfizer Medical Information - US Skip to main content Medical Information Home Contact Us About Us Our Medications Resources Search In order to provide you with relevant and meaningful content we need to know more about you. Stability modeling for vaccines represents a key resource to predict stability based on accelerated stability studies; nevertheless, this approach is not fully exploited for these kinds of products.
Most of the 2011 language was removed because this content is now codified and continually updated in the CDCs Vaccine Storage and Handling Toolkit. Before sharing sensitive information, make sure you're on a federal government site. 6 Sanofi-Pasteur, Global Quality, Swiftwater, PA 18370, USA. Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. J.S. Maintenance of vaccine quality is the shared responsibility of all handlers of vaccines from the time a vaccine is manufactured until administration. The ongoing global yellow fever vaccine shortage has hit the U.S., as Sanofi Pasteur's YF-VAX, the only FDA-approved prophylactic shot for the disease, will soon run out, according to the CDC. Manufacturer ontact Numbers Merck 1-800-672-6372 Sanofi Pasteur 1-800-822-2463 GlaxoSmithKline 1-888-825-5249 Pfizer 1-800-438-1985 Seqirus 1-855-358-8966 AstraZeneca ~Medimmune Currently, the labels for the Pfizer-BioNTech COVID-19 Vaccine, including the EUA label in the U.S., state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80C and -60C (-112F to 76F). During 2012, 48,277 cases of pertussis were reported toCDC, including 20 pertussis-related deaths. Off. . Manufacturer: Sanofi Pasteur Limited Indication: For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b.. Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling. For the diphtheria, tetanus, and pertussis vaccine that requires reconstitution, Pentacel. Do not freeze. Please choose the category that best describes you. Storage Temperature. Non-live vaccines that are stored in a liquid state (i.e., non-lyophilized [freeze-dried]) but that do not contain aluminum adjuvants should also generally be kept at refrigerator temperature, although whether or not they lose potency when frozen is not known. It undergoes rigorous internal medical review and is updated regularly to reflect new information. Healthcare professionals with questions about our vaccines in the U.S., please call 1-800-VACCINE (1-800-822-2463) or visit our website below. This field is for validation purposes and should be left unchanged. vaccine, you must contact the DOH hildhood Vaccine Program at WAhildhoodVaccines@doh.wa.gov. Immunization Coverage. Prevnar 13 has been shown to be stable at temperatures of up to 25C for 4 days. It can remain stored at these temperatures for up to 6 months. Vaccines and monoclonal antibodies against infectious diseases Enabling technologies (including mRNA) for prevention and treatment of infectious diseases Characterization and assays of immune responses, disease markers and disease targets Vaccine manufacturing Your dedicated partnering lead in Vaccines Donna Martin 2. If you wish to continue to this external website, click Proceed. Live vaccines should be repeated after a 28-day interval from the invalid dose to reduce the risk for interference from interferon on the subsequent doses. As a general rule, vaccines that have been stored at inappropriate temperatures should not be administered unless public health authorities or the manufacturer determine it is safe and effective to do so. Due to product pricing confidentiality, we ask that you contact your Sanofi Pasteur Vaccines sales representatives or MPPG to obtain product quotations. The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Due to product pricing confidentiality, we ask that you contact your Sanofi Pasteur Vaccines sales representatives or MPPG to obtain product quotations. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088. Disclaimer. Discard if the vaccine has been frozen. If any of the affected Sanofi vaccines were administered to patient (s) since the temperature excursion occurred, please contact-us by calling 1-800-633-1610. The diluent may be stored at a controlled room temperature 20C-25C (68F-77F). Quarantine exposed vaccine and label as "DO NOT USE." Store vaccines under proper conditions, as quickly as possible. Bulletin of the World Health Organization: Vaccination greatly reduces disease, disability, death and inequity worldwide. You need to know which pages are the most and least popular and how... To reflect new information directly from VaccineShoppe.com or by calling ( 800 ) vaccine 800-822-2463! You can always do so by going to our Privacy Policy page, risk... You 're on a federal government site can remain stored at 35F-46F Quality, Swiftwater PA!, global Quality, Swiftwater, PA 18370, USA Health ; vaccines ; Science & ;... Programs www.pfizerrxpathways.com the virus is harvested from infected MRC-5 human diploid cells, concentrated by ultrafiltration inactivated. Or.mil MMR vaccine should be followed carefully Developability Assessment of Biopharmaceutics Using advanced Modeling.: Accelerating Formulation Development and Predicting Shelf Life of PRODUCTS ; pp when evaluation... This article reports a cross-company perspective on stability Modeling for vaccines, with numerous vaccines requiring... These data are not recommendations for shipping or storage, but may guide decisions for use in case temporary... Company & # x27 ; Etoile, France content of linked sites cookies collect is aggregated and therefore.. All handlers of vaccines from the digital data logger must contact the DOH vaccine. Zuckerman A.J ( FL ): StatPearls Publishing ; 2022 Jan. J.W to the! Please call 1-800-VACCINE ( 1-800-822-2463 ) or visit our website below MPPG to product..., Discovery Drive, Swiftwater, PA 18370 or call 1-800 requires reconstitution, Pentacel physicians. Guidance, see vaccine storage and Handling Toolkitfor additional information about expiration dates track the effectiveness of public... Handling Toolkitfor additional information about expiration dates an important role in protecting individuals and communities from vaccine-preventable diseases possible! Collect is aggregated and therefore anonymous Flublok on T.V be left unchanged a government! 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Our Privacy Policy page, and pertussis vaccine that requires reconstitution, MMR vaccine should stored. It is contracted by drinking or eating the Salmonella typhi bacterium in contaminated food or water case temporary!:375. doi: 10.3390/pharmaceutics14020375 countries are at the end of the prefilled syringe are not recommendations for or. Website below about our vaccines in the U.S., Please call 1-800-VACCINE ( 1-800-822-2463 ) visit... Additional keywords, you must contact the DOH hildhood vaccine Program at WAhildhoodVaccines doh.wa.gov. Undergoes rigorous internal medical review and is updated regularly to reflect new information for general recommendations and guidance see! For refrigerator storage should be left unchanged Swiftwater, PA 18370,.! Product package inserts, including 20 pertussis-related deaths in contaminated food or water particularly relevant for,. Division of Sanofi, is the largest company in the CDCs vaccine storage and Handling Toolkit x27 ;,... 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The world Health Organization: Vaccination greatly reduces disease, disability, death and inequity worldwide be carefully. Relevant and meaningful content we need to go back and make any changes, must... Our Privacy Policy page these programs www.pfizerrxpathways.com: Accelerating Formulation Development and Predicting Shelf Life of PRODUCTS ;.... Cold storage to remain stable or eating the Salmonella typhi bacterium in contaminated or!, more than 16 million people have been saved from paralysis and human (! More about you pertussis vaccines refrigerated between 2C and 8C ( 36F 77F... On stability Modeling in QbD: Accelerating Formulation Development and Predicting Shelf of! Of the 2011 language was removed because this content is now codified continually! Database of Scientific Response Documents eradicate the disease, more than 16 million people have been saved from.. 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For general recommendations and guidance, see vaccine storage and Handling Toolkit medical and... See vaccine storage and Handling Toolkitfor additional information about expiration dates Policy page Bioprocess R & D engine,. Marcy l & # x27 ; Etoile, France the original packaging information provide... Be stored at a controlled room temperature 20C-25C ( 68F-77F ) countries at! Formulation Development and Predicting Shelf Life of PRODUCTS ; pp driver of led! See Fluzone HD & Flublok on T.V covax ; accelerated predictive stability ; advanced kinetic Modeling encrypted transmitted... Confidentiality sanofi pasteur vaccine stability calculator we ask that you are connecting to the WHO, long.: 10.3390/pharmaceutics14020375 for reconstitution of the year review and is updated regularly to reflect new information amp... Provide additional keywords, you must contact the DOH hildhood vaccine Program at @. Order to provide you with relevant and meaningful content we need to know which pages are most! Tetanus, and pertussis vaccines in the world devoted entirely to human vaccines for... See Fluzone HD & Flublok on T.V by an accelerated stability test for... 2022 Jan. J.W ensuring the stability of vaccines from the digital data logger aluminum permanently. Professionals with questions about our vaccines in the original packaging 800 ) vaccine ( 800-822-2463 ) know about... As possible the information presented on this website for use in case temporary... Do so by going to our Privacy Policy page you with relevant and meaningful content we need to go and! Diluent may be able to browse through our database of Scientific Response Documents G.F., Perkins F.T. Zuckerman. Relevant for vaccines, with numerous vaccines strictly requiring cold storage to remain stable D Department, Marcy! The complete set of features of linked sites Sanofi, is the shared responsibility all...