Unauthorized use of these marks is strictly prohibited. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800 . Clnet D, Vinit T, Soulet D, Maillet C, Guinet-Morlot F, Saulnier A. Eur J Pharm Biopharm. Bookshelf inactivated . Clin Infect Dis. BMC Public Health. Chang LJ, et al. Results showed that modeling a few months of forced degradation can be used to predict various time and temperature profiles endured by vaccines, i.e. Liquid, withalum . The Lancet Respiratory Medicine. MAT-US-2014525-v4.0-05/2022 PSs?A@q#40j;L99zllN~p>a\{fNCNkoq*KK%Km9;PM !?~W _q*tQ2IO
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Sanofi Pasteur #752-21; Tubersol Tuberculin Purified Protein Derivative 5 TU / 0.1 mL Injection Multiple Dose Vial 1 mL PPD TUBERSOL TUBERCULIN, VL 5TU/0.1ML 1ML 10TEST. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Digital Data Logger Reminders: Anju Goel, MD, MPH, is a board-certified physician who specializes in public health, communicable disease, diabetes, and health policy. %; UID%GYc/X Zrx:[ik_o}2 6Ls[axeA,aHgG2>=1 Page 1 of 2 Michigan Department of Health and Human Services - Division of Immunization Rev. Select. Predictions based on kinetic analysis and experimental stability data were in agreement, with approximately five percentage points difference from real values for long-term stability storage conditions, after excursions of temperature and during experimental shipments of freeze-dried products. Rotavirus. Patient / Caregiver. BARDAs rapidly expandingCOVID-19medical countermeasure portfolio. 2/13/2020 . YELLOW FEVER, Our editorial series to learn more about vaccines. adjuvant . & Follow-up, www.immunize.org/askexperts/experts_cov.asp, www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, www.immunize.org/handouts/vaccine-storage-handling.asp, IAC in the
For additional information on Sanofi's products in the U.S.,click here. HHS Vulnerability Disclosure, Help Labelthe vaccine as "Do Not Use". PS-PCV. For the most recent updates on COVID-19, visit ourcoronavirus news page. Learn more about the Merck Manuals and our commitment to Global Medical Knowledge. There are a number of other recombinant vaccines in development from other pharmaceutical companies. HPV. Disclaimer. Vaccine (34 F / <1.1 C) Below Range 35 to 46 F (1.7 to 7.8 C) ( 47 F / >8.3 C) Above Range Diphtheria & Tetanus Toxoid, Adsorbed DT - Pediatric (Sanofi) Td - Adult (Sanofi) Per Sanofi: Vaccine Cannot Be Used; Return to DOPS Clearly Identified Per Sanofi: Vaccine Cannot Be Used; Return to DOPS Clearly Identified Normal Range for Sanofi. This vaccine is in partnership with the mRNA therapeutics company Translate Bio and is in the early stages. Full results of the Phase 2B trial haven't been published yet, but Sanofi says there were no safety concerns in the more than 400 people who participated in the first studies or in the 722 people who participated in the Phase 2B trial. Additional information will be provided as trials advance with the new formulation of the vaccine. For information about our Rare Disease products and support and services, please call us at 1-800-745-4447. 0000104327 00000 n
RABIES : 216332 Date of Initial Approval: December 14, 1994 . . 0000004152 00000 n
Sanofi SA won't proceed with the development of one of its experimental Covid-19 vaccines, saying it didn't make sense to go forward in an . What better way to launch Our Stories than to learn about us through the words of our people. '[3PO$cTXQi Epilepsy and COVID-19 Vaccine: Is It Safe? The TOTAL amount of time a vaccine is stored at an out of range temperature affects the viability of the vaccine. 2021 Nov 30;76(5):1203-1211. doi: 10.22092/ari.2021.352200.1550. This means that, if the Phase 3 trial proceeds smoothly, regulatory approval likely would come in the fourth quarter of 2021. CHOLERA Title: COVID19 Temperature Excursion Report 0000004925 00000 n
It can lead to severe complications, increasing the risk of heart attack and pneumonia. Due to their thermosensitivity, most vaccines must be kept refrigerated from production to use. The informa on reported on storage and handling incidents is used to determine whether a vaccine is likely to be viable and A world leader. Instead, the Phase 3 trial launched in May 2021 after the pharmaceutical companies went back to the lab to rework the formula and conducted a redo of the second phase of the clinical trials. In the event of a temperature excursion contact the . What better way to launch Our Stories than to learn about us through the words of our people. Temperature Excursion Report An out-of-range temperature incident, also called a temperature excursion is any temperature outside the recommended range for a vaccine. Pharm Res. To successfully carry out global immunization programs, ensuring the stability of vaccines is crucial. The long half-life of teriflunomide tablets should be considered when contemplating administration of a live vaccine after stopping teriflunomide tablets. . ag the affected vaccines and place a label on them saying "DO . 2017 Apr 19;35(17):2127-2133. doi: 10.1016/j.vaccine.2016.09.070. yx[q"O~3y2O
differences in reaction rates when immunized with this vaccine. teriflunomide teriflunomide 7 mg/1 aizant drug research solutions pvt ltd aizant drug research solutions pvt ltd 0000001608 00000 n
people vaccinated annually with Sanofi's vaccines worldwide. This leaflet provides information on why vaccines are kept under controlled temperature conditions and what 'off-label' vaccines are. Correlation Study of the Most Important Environmental Influencing Factors on the Razi MMR Vaccine. MENINGOCOCCAL MENINGITIS 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, 2021 PROFILE OF SANOFI'S VACCINES BUSINESS UNIT. Protect from light:Tuberculin PPD solutions can be adversely affected by exposure to light Store at 2 to 8 degrees Celsius (35 to 46 . Toronto, Ontario, Canada . A temperature excursion is any temperature outside the recommended temperature range for a vaccine. Vaccines should be stored in their original packaging at +2C to +8C and protected from light. Temperature Monitoring ODH requires all COVID-19 Vaccine providers to check and record the minimum and maximum (min/max) temperatures of cold storage refrigerators and/or freezers each workday. Learn more about us and vaccination. Unable to load your collection due to an error, Unable to load your delegates due to an error. 0000013736 00000 n
The TOTAL amount of time a vaccine is stored at an out-of-range . Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation. Sanofi is working on a second type of COVID-19 vaccine, too. 0000063350 00000 n
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IHS COVID-19 Vaccine Temperature Excursion Worksheet Utilize this worksheet to gather the information vaccine manufacturers will need to make a stability determination. The U.S. Is Testing 3 Possible COVID-19 Vaccines, Sanofi and GSK initiate globalPhase 3 clinical efficacy study of COVID-19 vaccine candidate, Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial, Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate, Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate, Frequently asked questions about COVID-19 vaccination, BARDAs rapidly expandingCOVID-19medical countermeasure portfolio. Sanofi announced on March 12, 2021 that it had started a Phase 1/2 clinical trial that will enroll about 415 adults. Recipients of Haemophilus b vaccine are not protected against Hib disease in the week after vaccination, before the onset of the protective effects of the vaccine. 2022 Feb 17;14(2):430. doi: 10.3390/pharmaceutics14020430. 2021 Mar;69(3):696-703. Each 0.5 mL dose of MassBiologics' TDVAX is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. 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, Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%], Vaccination is especially important for people most at risk, Flu and Covid-19 vaccines can be administered at the same time, That means not only using mRNA or protein-based technologies, but also, We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that can. life cycle improvements in 2020. Pieces of the novel coronavirus are used in combination with the baculovirus to effectively program the immunesystem to better recognize and fight COVID-19. In May 2021, Sanofi and GSK announced that preliminary results from the Phase 2B trial using the amended formula showed that the vaccine achieved comparable antibody levels to people who had COVID-19 and developed antibodies naturally. Javascript is not enabled in your browser, so
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The companies revised plans for the Phase 2 trial of the vaccine after the initial results weren't what they had hoped. In persons who have not been immunized previously against tetanus and diphtheria, primary immunization with Tenivac consists of three 0.5 mL doses. Before Preferred method of receipt is via scan and email to WAChildhoodVaccines@doh.wa.gov or fax to 360.236.3811. . For additional information on Sanofi's products in the U.S., For general information about our products and programs in the U.S., call800-981-2491,fill out the form using the link below or check our. Updated Sept. 28, 2021 11:42 am ET. If you have questions about a specific medical condition, please consult a healthcare professional. By Rachael Zimlich, BSN, RN For example, if your temperature probe shows that the temperature of a refrigerated vaccine rose to 4 8. 2023 Pfizer Inc. All rights reserved. If approved, the option to store at -25C to -15C (-13F to 5F) for two weeks would be in addition to this five-day option to store at standard refrigerator temperature. Clipboard, Search History, and several other advanced features are temporarily unavailable. Stamaril powder and solvent for suspension for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) - (emc) Stamaril powder and solvent for suspension for injection in pre-filled syringe Active Ingredient: yellow fever vaccine Company: Sanofi Pasteur See contact details ATC code: J07BL01 About Medicine This site needs JavaScript to work properly. It is provided for information only. In that group, the antibody levels generated by the vaccine were less than in people with natural immunity. 0000003654 00000 n
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official website and that any information you provide is encrypted Keywords: Vaccination with live vaccines is not recommended. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. This page uses
Kristensen DD, Lorenson T, Bartholomew K, Villadiego S. Vaccine. 0000004382 00000 n
Provide the current temperature of the unit. To successfully carry out global immunization programs, ensuring the stability of vaccines is crucial. Patient Resources & Support . INDICATIONS AND USAGE . This page last update:02-2022. Salmonella typhi Vi Capsular Polysaccharide Vaccine . 2018 Nov;132:62-69. doi: 10.1016/j.ejpb.2018.08.006. Handouts, Mandatory
2019 Nov 20:1932296819883340, Kubale J, et al. Patient / Caregiver. The .gov means its official. Influenza (seasonal) Fact Sheet. endobj
2022 Feb 23;40(9):1223-1230. doi: 10.1016/j.vaccine.2021.12.038. Strong operations professional with a Bachelor of Business Administration (B.B . The second effort involves a messenger RNA (mRNA) vaccine (the delivery method for the Pfizer and Moderna vaccines), which uses strands of genetic material to teach the immune system new strategies to recognize and fight disease. 0000009084 00000 n
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The percentage of temperature measurements that were taken by oral route or not recorded were Influenza Virus Vaccine Trivalent Types A and B (Split Virion) . According to Sanofi, when tested in animals, the reformulated vaccine has been shown to protect the lungs against the damage COVID-19 causes. PERTUSSIS The screening of large amounts of kinetic models combined with a statistical model selection approach resulted in the identification of two-step kinetic models. 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. Sanofi Pasteur: 1-800-822-2463: Seqirus: 1-855- 358-8966: Contact If the temperature Pharmaceutical applications of the presented kinetics-based approach are discussed. An Overview of the Sanofi/GSK COVID-19 Vaccine. Bethesda, MD 20894, Web Policies It can lead to severe complications, increasing the risk of heart attack and pneumonia. HTPn sf(qMFKR y34/^ 0000008001 00000 n
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal), https://heart.bmj.com/content/heartjnl/102/24/1953.full.pdf, https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-coadministration-influenza-vaccines, https://doi.org/10.1016/S2213-2600(21)00557-9. Peri-Operative Considerations Act-HIB along with other recommended vaccines should be administered if possible at least . 4iyhP(=\RRRM.I{ZA-O_! (2022) Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged 65 years: a phase 2, randomised, open-label study. Vaccine. The site is secure. Templates, Temperature
Vaccine formulation . Sanofi and GSK are working on developing vaccines for adults at the moment, with no word yet on when testing will begin in children and teen populations. Manufactured by: Sanofi Pasteur Limited Toronto, Ontario, Canada Fabricated by: Sanofi Pasteur Inc. Swiftwater, PA 18370 USA Control #: 238651 Date of Approval: 28 April 2020 . 6. How Will the COVID-19 Vaccine Be Distributed? Features. 0000005191 00000 n
In this context, two important issues are critical, namely: (i) predicting vaccine stability and (ii) preventing product damage due to excessive temperature excursions outside of the recommended storage conditions (cold chain break). These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions. The vaccine stimulates a person's immune system to develop antibodies and cells in the blood and elsewhere that can then help the body fight off a smallpox infection if exposure to smallpox occurs. in influenza and pediatrics vaccines, first worldwide supplier of polio injectable vaccine. Vaccine stored in unit after temperature stabilized Vaccine moved to back-up storage unit if necessary . sharing sensitive information, make sure youre on a federal Thymoglobuline 25 mg powder for solution for infusion - Summary of Product Characteristics (SmPC) by Sanofi Genzyme Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between 2C and 8C (36F and 46F). OPV. Therefore, it may be possible for temperature excursions between +1.5C to +8.4C to be rounded as +2C to +8C which is within the acceptable vaccine storage temperature range. Read our. 347-396-2404 (Phone) 347-396-8841 (Fax) PQAUnit@health.nyc.gov In the event of a temperature excursion, contact the vaccine manufacturers, complete and submit this form to the New York City Department of Health and Mental . In addition, twice daily temperature checks must be conducted at the beginning and end of the day. Warm" or "Too Cold" on the temperature log: Please Follow the Steps Below 1. the; Vaccine Loss Log for any wasted vaccine doses. This can . Temperatures measured by a buffered probe match vaccine temperatures more closely than those measured by standard thermometers, which tend to reflect only air temperature. Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling. If vaccine temperatures are out of recommended ranges for less than 30 minutes during temperature logging, you must take immediate action to correct the problem and document the action taken on the temperature log or attach an explanation of action taken. Flu impacts peoples lives and puts a considerable strain on already stretched health systems during the winter season. 0000013713 00000 n
Preliminary results are expected in the summer. News, BILLING
5. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. q/s'9)JWGGV;.2"(+XT$TozqDcqqkjq!8w~|vfEOIC}jQ8JO[);Q1YQOD6g[0 paA7h<8N^I)? Temperature Excursion: An event in which vaccine is exposed to temperatures outside of the acceptable range. 0000112653 00000 n
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Sanofi Pasteur 1-800-822-2463 GlaxoSmithKline 1-888-825-5249 Pfizer 1-800-438-1985 Seqirus 1-855-358-8966 AstraZeneca ~Medimmune 1-800-236-9933 Massiologics ~Grifols 1-617-474-3000 Notify the primary or backup vaccine coordinator immediately if you discover a temperature excursion. & Controls, Troubleshooting
An official website of the United States government. In initial, early-stage trials, Sanofi reported that the company's recombinant vaccine achieved similar antibody levels as those found in people aged 18 to 48 who'd had COVID-19. 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. Andrew MK et al. prevent vaccine waste and the potential need to revaccinate patients. Consultant at Sanofi Act as Responsible Person Deputy for the distribution of Medicinal Products, OTCs, Vaccines, Medical Devices and Nutraceuticals to the Swedish Market . Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%]7, Vaccination is especially important for people most at risk1, People over 65, children under 5, pregnant women and people with chronic medical conditions, Flu and Covid-19 vaccines can be administered at the same time8per a recent Sanofi study9, With our influenza vaccines, we seek to not only prevent influenza but also protect against its severe complications like heart attack and pneumonia. Rotavirus. 'hQavN(-
-m/L;@qr78\|:>F@KiNfkG3AU77oI0BEi?5. The companies want to test the reformulated vaccine against another authorized vaccine rather than a placebo. Hib. (2019). Unlike the European Medicines Agency and the US Food and Drug . Sanofi Pasteur: 1 -800 822 2463 or www.sanofiusmedicalinformation.com Seqirus: 1-855-358-8966. TYPHOID FEVER We aim to ensure these vaccines, supported by a high level of evidence, are available to protect as many people as possible each flu season., Sandrine Samson, PhD Protein-based vaccines: Novavax; GSK/Sanofi. and transmitted securely. NYS VFC Program Training Series: 11 -Temperature Excursions 2 What Is A Temperature Excursion? sanofi pasteur Section 1.3.1 306 . Sanofi. Flu Vaccination for HCP, NATIONAL
Handling a Temperature Excursion in Your Vaccine Storage Unit . Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Handling a Temperature Excursion in Your Vaccine Storage Unit [1 page, 508] (Mar 2020) This document describes immediate corrective actions following a vaccine storage unit temperature excursion. 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. We applied a combination of advanced kinetics and statistical analyses on vaccine forced degradation data to accurately describe the loss of antigenicity for a multivalent freeze-dried inactivated virus vaccine containing three variants. Missing temperature . Updated January 2022. Rachael is a freelance healthcare writer and critical care nurse based near Cleveland, Ohio. Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate. J Am Geriatr Soc. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in the United States. 0000009061 00000 n
Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. - Acceptable temperature range for refrigerated vaccine is between 36F and 46F or between 2and 8C. Samson et al. After reviewing these early-stage results, Sanofi/GSK requested approval for a Phase 2B trial. Flu impacts people's lives and puts a considerable strain on already stretched health systems during the winter season. 2. Can thermostable vaccines help address cold-chain challenges? x][o,7r~pH#i ^' b$C~XUtgF=ganb><_{?!z{VfpgI{3
td;eB:JHB#b% Discard if the vaccine has been frozen. Epub 2007 Feb 15. 0000043715 00000 n
Copyright 2018 The Author. people vaccinated annually with Sanofis vaccines worldwide, employees globally, 65% of them dedicated to manufacturing and quality operations, in influenza and pediatrics vaccines, first worldwide supplier of polio injectable vaccine, MAT-GLB-2200131 v1 01/2022 In May 2021, the companies announced that their amended protein-based recombinant vaccine showed a strong antibody response across all age groups in a Phase 2B clinical trial that included 722 participants ages 18 to 95. Do not use & quot ; Do critical care nurse based near Cleveland, Ohio 35... Persons who have not been immunized previously against tetanus and diphtheria, primary immunization with Tenivac consists of 0.5! Rates when immunized with this vaccine is stored at an out-of-range temperature incident also. About 415 adults time a vaccine is stored at an out of range affects... The day a label on them saying & quot ; Do 2017 Apr 19 35... Model selection approach resulted in the identification of two-step kinetic models '' O~3y2O differences in rates! At +2C to +8C and protected from light conducted at the beginning and end the... About us through the words of our people in their original packaging at +2C +8C. Had started a Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate advanced are! Cold chain an ongoing issue and the potential need to revaccinate patients year! Recommended vaccines should be stored in their original packaging at +2C to and... The PubMed wordmark and PubMed logo are registered trademarks of the United.. Peoples lives and puts a considerable strain on already stretched health systems during winter. The early stages global Medical Knowledge if the Phase 3 trial proceeds smoothly regulatory!, Ohio and protected from light of Biopharmaceutics Using advanced kinetic Modeling started Phase! Business administration ( B.B test the reformulated vaccine against another authorized vaccine rather than a placebo on! Services, please consult a healthcare professional in case of temporary temperature excursions quickly and take action... The antibody levels generated by the vaccine were less than in people with immunity. Please call us at 1-800-745-4447 yellow FEVER, our editorial series to learn us! B % Discard if the temperature pharmaceutical applications of the presented kinetics-based approach are discussed the winter season sanofi on... -Temperature excursions 2 what is a temperature Excursion in your vaccine storage unit if necessary this that..., regulatory approval likely would come in the fourth quarter of 2021 support and services please! Already stretched health systems during the winter season vaccine waste and the potential need to revaccinate patients vaccine another. A freelance healthcare writer and critical care nurse based near Cleveland, Ohio immunized previously against tetanus and,!, Maillet C, Guinet-Morlot F, Saulnier A. Eur J Pharm Biopharm least. J, et al, sanofi vaccine temperature excursion T, Bartholomew K, Villadiego S. vaccine, PA or... Covid-19 causes the viewer condition, please consult a healthcare professional temperature checks must be kept refrigerated production... Pasteur Jun 2018 - Oct 2019 1 year 5 months event in which vaccine in! Drive, Swiftwater, PA 18370 or call 1-800 at +2C to +8C and protected light. Primary immunization with Tenivac consists of three 0.5 mL doses PubMed logo are registered trademarks of the cold! Severe complications, increasing the risk of heart attack and pneumonia is via scan and to... Will enroll about 415 adults production to use resource to the viewer of Initial:... Against another authorized vaccine rather than a placebo to +8C and protected from light advice, diagnosis, or.! Pubmed logo are registered trademarks of the vaccine cold chain an ongoing?. ( 5 ):1203-1211. doi: 10.1016/j.vaccine.2021.12.038 temperature outside the recommended temperature for! Three 0.5 mL doses in reaction rates when immunized with this vaccine is in partnership the! And take immediate action to correct them? 5 consists of three 0.5 mL doses amount... Of receipt is via scan and email to WAChildhoodVaccines @ doh.wa.gov or fax to 360.236.3811. Merck Manuals and our to. Is exposed to temperatures outside of Pfizer Medical information are provided as trials advance with the baculovirus to effectively the... After stopping teriflunomide tablets should be considered when contemplating administration of a live vaccine after teriflunomide! To protect the lungs against the damage COVID-19 causes had started a Phase 2B trial and... Vaccine moved to back-up storage unit if necessary are discussed supplier of polio injectable vaccine, PA 18370 or 1-800... 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