. . Pfizer's vaccine needs a storage temperature of -70 degrees C. The storage . reading outside the recommended range for vaccine storage is a temperature excursion. Upon receipt, store refrigerated at 2C to 8C (36F to 46F). Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA Friday, February 19, 2021 - 07:00am Proposed U.S. EUA label update would enable the vaccine to be stored at -25C to -15C (-13F to 5F) for a total of two weeks It is a Record the date and time . . The vial for children 5 through 11 years of age has an orange cap and orange border on the label. Comirnaty 10 micrograms/dose concentrate for dispersion for injection Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified) - Summary of . Updated the Public Assessment report, to reflect the extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds, as . More information about Pfizer-BioNTech storage can be foundhere. 650 people received the Pfizer vaccine doses that were kept at a colder temperature than what protocols call for. (Does not include McKesson or Merck shipping container or Pfizer Single Use Thermal Shipper) In case of a temperature excursion, call the manufacturers to determine vaccine viability Pfizer-BioNTech (800) 438-1985 Moderna (866) 663-3762 To e nsure only viable vaccine is administered, it is vital to follow the below steps. of vaccine. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C until the expiry date printed on the label. The COVID-19 vaccine must be handled and stored at a cold temperature until the vaccine is administered with Moderna's kept at minus 20 Celsius, and Pfizer's at minus 70 Celsius. Each vial carries a limited number of doses. POD that de-consolidate vaccine trays are responsible for: Temperature excursion: is any temperature reading outside of the recommended range for vaccine storage as defined in the manufacturer's package insert. Vaccine may be stored for up to two weeks at regular freezer temperatures (as defined in the chart above). . What is the Cold Chain? Each day the site is open, each Ohio COVID-19 Vaccine provider is required to check and record: The minimum and maximum (min/max) temperatures of cold storage refrigerators and/or freezers CDC Product Info: Pfizer-BioNTech COVID-19 Vaccine . NY 10017 . Monitor Pfizer-BioNTech COVID-19 Vaccine (orange cap) is authorized for use to provide: a 2-dose primary series to individuals 5 through 11 years of age; a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise; and a single booster dose to individuals 5 through 11 years of age who have completed a . The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart. Minimum order: 300 doses (6-dose multidose vial) COVID-19 Vaccines Washington State Department of Health | 6 Vaccine will arrive at a temperature between - 80C and -60C (-112F to -76F) in a thermal shipping container with dry ice. If yes, provide the brand, lot numbers, and number of doses of the affected vaccines during the No. The new . 800-666-7248 cvgovernment@pfizer.com. intramuscularly. If storing the vaccine at refrigerator temperatures between 2C and 8C (36F and 46F), the vaccine must . South Carolina COVID-19 Vaccine Management (03/2021) 3. McKesson will initiate a process for sending a COVID-19 Vaccine Temperature Excursion Policy - This document provides the requirement for all enrolled providers to report any excursions or storage and handling incidents involving COVID-19 vaccine to CDPHE . adverse events of concern in association with Comirnaty can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com. The preferred storage range is ultracold. Phone: 833-272-6635 Monday - Friday, 7 a.m. - 7 p.m. CST Email: covidvaccinesupport@mckesson.com (only send email if after hours) In a temperature excursion, having a laptop with the appropriate LogTag software5 installed and a cradle at the clinic location will help expedite the proper procedure. COVID-19 Vaccine Provider Checklist . Place any COVID-19 vaccine shipments exposed to out-of-range ALBUQUERQUE, N.M. . . Unpunctured PBS formulated BioNTech/Pfizer COVID-19 mRNA vaccine vials can . Storage within this temperature range is not considered an excursion from the recommended storage condition. 1-800-438-1985. to report the vaccine temperature excursion. A Freezer temperature monitoring chart is available to order from Stream Solutions to record this: . The toolkit was revised in 2021 with an addendum addressing COVID-19 vaccines. An independent review is being planned as New Haven officials continue to piece together what led up to a temperature excursion that affected hundreds of its Pfizer COVID vaccines that went . An ancillary supply kit will arrive separately from the vaccine. The vaccine will arrive in a thermal shipping container at ultra-cold temperatures between -90C and -60C (-130F and -76F) with dry ice or between -25C and -15C (-13F and 5F). Moderna COVID-19 Vaccine Pfizer COVID-19 Vaccine 1 . Janssen . Customer Service and Product Inquiries: 1-800-879-3477 Monday through Friday 9:00 a.m. to 7:00 p.m. EST. Handling of temperature . Nov. 2, 2021: Following the FDA's EUA approval, McKesson begins distributing the ancillary supply kits needed to administer Pfizer-BioNTech COVID-19 vaccines for children ages 5-11. to decrease likelihood of temperature excursions and disruption to physical stability of vaccine. CDC presentation about the Pfizer-BioNTech COVID-19 Vaccine (PDF) CDC presentation about the Use of mRNA COVID-19 Vaccines; Presentation by Dr. Jay Butler, Deputy Director for CDC Infectious Disease: Addressing Alaska Health Care Stakeholders . Program at 1-802-863-7638. Pfizer-BioNTech COVID-19 Vaccine: 1. Moderna vaccine temperature excursion. Refrigerator Freezer ULT Freezer/ Original Thermal Shipper Pfizer 2C to 8C (36F to 46F) -25C to -15C (-13F to 5F) California COVID-19 Vaccination Program IMM-1305 (4/8/21) Data Loggers Each vaccine storage unit must have a temperature monitoring device to ensure that vaccines are stored within the recommended temperature range. Moderna vaccine had a temperature excursion during shipment: Questions and concerns about vaccine viability issues . Moderna. of first use on the J & J COVID-19 vaccine vial label. Vaccine Handling Toolkit; . "The Alabama Department of Public Health (ADPH) is aware that two trays of Pfizer COVID 19 vaccine sustained temperature excursion during shipment and that those trays were not released to any . COVID-19 TEMPERATURE EXCURSION REPORT Complete and submit this report when COVID -19 vaccine have been exposed to temperatures out of range. McKesson. Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine. Related Articles Phase 1B: What you need to know . DOH 348-708 April 2022 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. Vaccine can be stored for 6 months at -80C to 60C. After shipping, Prevnar 13 may arrive at temperatures between 2C to 25C (36F to 77F). . An average winter . Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary Basics . USA. be used within 1 month (31 days). 1. Contact Pfizer at . In addition, twice daily temperature checks must be conducted at the beginning and end of the day. The Covid-19 vaccine made by Johnson & Johnson, which utilizes adenovirus vector technology, is transported and stored at refrigerator temperatures, or about 6 degrees Celsius. 4. Pfizer-BioNTech COVID-19 Vaccine (5 to 11 years of age - orange cap AND 12+ - gray cap) Vaccine Temperature Ranges: Ultra-cold (ULC): -90C to -60C (-130F to -76F) . COVID-19 Responding to Temperature Excursions Separate COVID-19 vaccines exposed to inappropriate temperatures from other vaccines, label the vaccines "Do Not Use", and store at recommended temperatures until vaccine viability is determined. The new Pfizer Tris Sucrose adult/adolescent formulation (gray cap) is now available for people age 12 years and older. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be . Pfizer materials have been updated to include the updated Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States posted on February 22, 2022. However, it is generally the total amount of time, or cumulative time . Recommended Temperature Ranges MANUFACTURER REFRIGERATOR FREEZER ULT FREEZER THERMAL SHIPPER Pfizer, Age 12+ (purple cap) 2 C to 8 C (36 F to 46 F) 31 days -25 C to -15 C (-13 F to 5 F) 2 weeks cumulative -90 C to -60 C (-130 F and -76 F) Until expiration date You should contact the manufacturer if you have a temperature excursion to see if the vaccine is still viable. This approach helps to quantify the degree to which temperature excursions impact vaccine quality and can also reduce vaccine wastage. This is the ability to take the liquid vaccine and put it into vials that can be distributed. Manufacturer Phone Number Email Address: . Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with an orange cap and a label with an orange border. Upon receiving the Pfizer -BioNTech Covid-19 Vaccine, Points of Distribution (POD) must check vaccine temperature and store vaccines at recommended temperatures immediately. Pfizer Vaccines - (800) 438-1985 www.pfizermedicalinformation.com ; Pfizer MDV Pfizer case #/Person contacted: Moderna (866-) 663-3 762 ; Vaccines exposed to temperature excursions must be labeled "Do Not Use" until more information is gathered by the Immunization Program. Contacts; Topic or Problem Contact; Johnson & Johnson vaccine shipment had a temperature excursion during shipment: Questions/concerns about vaccine viability issues (temperature excursions) during shipment must be reported on the same day as delivery. Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. dose of vaccine, carefully . Once returned to ultra-cold storage, the 2-week time frame is suspended. Labels for Pfizer-BioNTech are availablehere. beginning of the workday to determine if any temperature excursions have occurred since the last temperature check. This is for adolescent doses and should not be used in individuals 12 years of age and older. Once thawed, the vaccine cannot be re-frozen. Nearly 650 people who received a Pfizer COVID-19 vaccine at a clinic in New Haven between Christmas and Feb. 7 will need to get another shot, city health officials said late Friday, because the . Refrigerated transport: Between 2C and 8C (36F and 46F) Unpunctured Vials: may be transported at refrigerated temperatures until the expiration date The total time for transport alone or transport + clinic workday should be a maximum of 8 hours (e.g., if transport to an off-site clinic is 1 hour each way, the clinic may run for up . . This includes new materials for the Pfizer-BioNTech COVID-19 vaccine formulation for 12 years of age and older (gray cap). Moderna vaccine temperature excursion. o Any time used for transport counts against the 31-day limit. receive a single COVID-19 booster vaccine (Pfizer - BioNTech, Moderna or Janssen) at least 2 months (8 weeks) after receiving their initial Janssen primary . Website: www.janssencovid19vaccine.com Moderna COVID-19 Vaccine Pfizer COVID-19 Vaccine 1 . The second major type of vaccine we are seeing used against COVID-19 is the adenovirus vector-based vaccines, like Johnson & Johnson's Janssen one-shot COVID-19 vaccine (Ad26.COV2-S [recombinant]) and Oxford/AstraZeneca's Vaxzevria. New York . Each dose must . Vaccine 1. ultra-cold temperature storage (-90C to -60C [-130F . . Pfizer 800-666-7248 cvgovernment@pfizer.com . McKesson will initiate a process for sending a While the Pfizer vaccine needs to be stored in a freezer at -94 degrees, most freezers are not designed for that level of cold - most are designed for -20 degrees. For Pfizer vaccine: Temperature Excursion Protocol December, 2021 . Utilize this worksheet to gather the information vaccine manufacturers will need to make a stability determination. ULTRA-FROZEN VACCINE Pfizer BioNTech VACCINE STORAGE REQUIREMENTS Vaccines that require ultra-low temperature ( -70C) for long term storage Vaccine should be stored at -80C to 60C in a laboratory grade ultra low temperature freezer. DHA/HRS/HPSD/ST-18 Issue Nu: 3.0 Issue Date: 22/02/2022 Effective Date: 22/02/2022 Revision Date: 22/02/2026 COVID Vaccine Temperature Excursion Report (PDF) Storage and handling . Involved in the assessment of temperature excursions, including the vaccine return process; Providing education for the storage and handling of ultra-low temperature (ULT) . Place the probe of a data logger in the questionable shipment, near the vaccine and replace the lid to gain the . 28 June 2021. So, you may want to take a look at our most frequently asked questions and answers before contacting us. 8AM-9PM ET Monday to Friday; excluding holidays. For more information, visit: coronavirus.ohio.gov An official at the Rocky Mountain Regional VA Medical Center in Colorado checks the temperature monitor on a shipment of the Pfizer-BioNTech Covid-19 vaccine. For ODH RSS shipments that arrive with a possible temperature excursion, please contact the ODH COVID-19 Provider Call Center . COVID-19 Pfizer Vaccine Order Requests - This order form is for placing a pediatric Pfizer dose order in a quantity of less than 100 . ag the affected vaccines and place a label on them saying "DO NOT USE." Do not discard these vaccines or remove them from the storage unit. Diluent and an ancillary supply kits will arrive separately from the vaccine The temperatures of storage units containing COVID-19 vaccine are required to be monitored at all times. Administer the dose . Another limitation is freezer capacity. mix the contents by swirling gently . Storage of the vials between -90C to -60C is not considered an excursion from the recommended storage condition. Phone: 1 -800-565-4008. Pfizer . Prefilled Syringe, 1 Dose (1 per package) - NDC 0005-1971-05. If there is a temperature excursion, please contact Pfizer Customer Support at 1-833-VAX-COVI (1-833 -829-2684) 2. Pfizer-BioNTech COVID-19 Vaccine (30 mcg / 0.3 mL) IM suspension Date & Time to discard (6 hours after dilution): Lot #: Initials of preparer: 1 2 1 2 Examples of Labels for Transport of Pfizer-BioNTech COVID-19 Vaccine * If the storage temperature is changed to an unmonitored temperature container, this changes the allowable storage time. Pfizer Inc. 235 East 42nd Street. Moderna, Pfizer, and Johnson & Johnson COVID-19 vaccine products are not interchangeable for use in primary series. COVID-19 Vaccine Wastage Form; Vaccine Incident Response & Temperature Excursion Worksheet; Pfizer _____ Pfizer COVID-19 Vaccine Official Website; Webpage: CDC Information on Pfizer-BioNTech COVID-19 Vaccine; EUA Fact Sheet for Healthcare Professionals (NEW! 4 . Pfizer materials have been updated to include the updated Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States posted on February 22, 2022. temperature excursion. temperature [up to 25C (77F)] . Pfizer and BioNTech's . Report Adverse Event Pfizer Safety This information must be documented on an ODH paper temperature log. o Pfizer-BioNTech COVID-19 Vaccine ("Pfizer-BioNTech vaccine") for use in those aged 12 years of age and older, which has a purple cap and label 2. Vaccine will arrive at a temperature between -90C and -60C (-130F to -76F) in a thermal shipping container with dry ice. Discard if the vaccine has been frozen. Original Pfizer COVID-19 Vaccine Temperature Ranges efore 6 dose multidose vials are punctured, Pfizer OVID-19 vaccine can be stored in three ranges for fixed maximum periods of time. COVID-19 Pfizer Pediatric Vaccine - Pfizer Pediatric Redistribution Guidelines Current as of May 3 2022 Introduction The prompt, safe, and efficient roll out of the provincial COVID-19 vaccine program is a critical priority for the B.C. for COVID-19 Vaccine Providers. vaccination record cards for recipients, vaccine needle and length guide. 8. . Prevnar 13 is stable at temperatures up to 25C (77F) for 4 days. COVID-19 Vaccine Temperature Excursion Guide Notify the primary or backup vaccine coordinator immediately if you discover a . Immediately unpack the thermal shipping container following the manufacturer's directions. 866-663-3762 Email not available. Additionally, McKesson is supporting the U.S. government and their mission of sending millions of COVID-19 vaccines to countries in need, around the world. Wastage Form and Temperature Excursion Worksheet. 2. Call 800-438-1985 * *Contact Medical Information. Seventy-five doses of the coveted Pfizer vaccine were discarded after they experienced a "temperature excursion" during transport to Clayton, officials with the state . Vaccine will arrive at a temperature between -90C and -60C (-130F to -76F) in a thermal shipping container with dry ice. Temperature Requirements Only providers with cold-storage facilities can hold the Pfizer-BioNTech vaccine for an extended period of time. . Download all applicable data logger information, as well as gather temperature logs or other details of the excursion. The vial for people 12 years of age and older that does NOT require diluent has a gray cap and gray border on the label. This document is designed to assist providers in properly storing and handli ng federal COVID-19 vaccine as part of the Tennessee Vaccine-Preventable Diseases and Immunization Program (VPDIP) COVID-19 Vaccination Program.