Pentacel is an example. Do not store vials at 25C to 15C (-13F to 5F). The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing followup were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. Record the date and time of first vial puncture (dilution) on the COMIRNATY (for age 6 months to <5 years) vial label. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. Adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%). safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. After dilution the vials should be stored at 2C to 25C (35F to 77F). If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C ( 130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). This content is intended for Canadian Healthcare Professionals. Discard any unused vaccine 12 hours after dilution. Of these, 1,762 participants (1,166 COMIRNATY 3 mcg; 596 placebo) received 2 doses and 1,207 (68.5%; 801 COMIRNATY 3 mcg and 406 placebo) participants have been followed for at least 4 months after the second dose; 570 participants received a 3-dose primary series (386 COMIRNATY 3 mcg; 184 placebo) and have been followed for a median of 1.3 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. Of these, 2,726 participants (1,819 COMIRNATY 3 mcg; 907 placebo) received 2 doses and 1,369 (50.2%; 910 COMIRNATY 3 mcg and 459 placebo) participants have been followed for at least 4 months after the second dose; 886 participants received a 3-dose primary series (606 COMIRNATY 3 mcg; 280 placebo) and have been followed for a median of 1.4 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. A carton of 10 vials may take up to 2 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. The safety evaluation of participants in Study 2 and Study 4 is ongoing. In a subset from Study 4 (Phase 3), 305 adults >55 years of age who had completed 3 doses of COMIRNATY, received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1, 4.7 to 11.5 months after receiving Dose 3. In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Do not add more than 1.3 mL of diluent. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. COMIRNATY Original & Omicron BA.4/BA.5 should not be given to those who have experienced anaphylaxis after a prior dose of COMIRNATY, COMIRNATY Original/Omicron BA.1, or COMIRNATY Original & Omicron BA.4/BA.5. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow up were reported by 29.1% of COMIRNATY recipients and by 26.3% of placebo recipients. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. Each 0.3 mL dose of COMIRNATY contains 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 1. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. The vaccine can be stored for five days at refrigerated 2-8C conditions. Each dose must contain 0.3 mL of vaccine. Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. Each 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 15 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 15 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. Do not store vials at 25C to 15C (-13F to 5F). Each vial must be thawed and diluted prior to administration. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. Do not pool excess vaccine from multiple vials. Anaphylaxis has been reported. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. After preparation, a single dose is 0.3 mL. The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. Fatigue was the most frequently reported systemic AR reported within 7 days after study vaccination, followed by headache, and less frequently chills, muscle and joint pain. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). However, the vaccines do not only reduce the chance . We take your privacy seriously. Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). Each vial must be thawed and diluted prior to administration. Vaccines are one of the greatest health interventions ever developed. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 3 to 6 months after completing the primary course of COMIRNATY and/or a previous booster dose of COMIRNATY in individuals 12 years of age or older. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. 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. Document the current date, the vaccine lot number, and the updated expiration date. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. Any vaccine remaining in vials must be discarded after 6 hours. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. Not all pack sizes may be available. At the time of the analysis of Study 2 (data accrued through March 13, 2021), a total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period. A free web-based tool to manage vaccine administration and registration Information Immunization Systems (IIS) IIS consolidate immunization information into one reliable source VTrckS CDC's vaccine order management system and platform for all COVID-19 vaccine ordering IZ Gateway A cloud-based message routing service intended to enable data exchange Sorry, you need to enable JavaScript to visit this website. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Not all pack sizes may be available. Thus, each tray of the Pfizer COVID-19 vaccine is now 1,170 does (195 vial x 6 doses/vial). Dispatches from the Backyard Chicken Movement. Participants 16 Years of Age and Older After Booster Dose. For further assistance with reporting to VAERS, call 1-800-822-7967. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: Thank you for taking the time to confirm your preferences. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. Do not use if vaccine is discoloured or contains particulate matter. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Solicited Local and Systemic Adverse Reactions. For 12 Years of Age and OlderCOMIRNATY is a suspension for intramuscular injection. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through 12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. Prior to dilution, the thawed suspension may contain opaque amorphous particles. Serious Adverse EventsIn Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY =12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. Transportation of Frozen VialsIf local redistribution is needed and full cartons containing vials cannot be transported at 90C to 60C (130F to 76F), vials may be transported at -25C to 15C (-13F to 5F). Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 years) preferentially using a low dead-volume syringe and/or needle. The date printed on the vial and carton reflects the date of manufacture. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. Where is the Pfizer-BioNTech COVID-19 vaccine made? Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Frozen Vials Prior to UseCartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE)arrive in thermal containers with dry ice. Today, Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Each 0.2 mL dose of COMIRNATY contains 3 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. b. The liquid is a white to off-white suspension and may contain. No Grade 4 systemic events were reported. Most systemic events were mild or moderate in severity. Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection,USP prior to use. Acarton of10vials may take up to6hours to thaw at this temperature. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. All participants were monitored for solicited local and systemic reactions and use of antipyretic medication after vaccination with an electronic diary during the 7 days following the dose of vaccination. Each 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 5 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 5 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5) and the non-medicinal ingredients listed in Table 2. The vial stoppers are not made with natural rubber latex. The safety and efficacy of COMIRNATY Original & Omicron BA.4/BA.5 in children under 5years of age have not yet been established (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). If received at 2C to 8C, they should be stored at 2C to 8C. Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. Strict adherence to aseptic techniques must be followed. Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Table 17: Study 3 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. dose. Visually inspect each dose in the dosing syringe prior to administration. Visually inspect each dose in the dosing syringe prior to administration. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. Vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. During the visual inspection: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. f. Severe: 6 or more loose stools in 24 hours. They help us to know which pages are the most and least popular and see how visitors move around the site. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. Do not add more than 1.8 mL of diluent. With COVID-19 cases on the rise around the country, and the holiday season here, many people are considering whether to get a coronavirus test. No interaction studies have been performed. All information these cookies collect is aggregated and therefore anonymous. Centers for Disease Control and Prevention. Overall, participants who received a booster dose in Study C4591031 (Study 4), had a median follow-up time of 2.5 months after the booster dose to the cut-off date (October 5, 2021). The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for age 5 years to <12 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. Children 5 Years Through 12 Years of Age After Booster Dose. Table 11: Study 2 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*, Table 12: Study 2 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code After dilution, the vaccine vials can be handled in room light conditions. Gently invert the vial containing COMIRNATY 10 times to mix. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Administer immediately, and no later than 12 hours after dilution. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). 1) The manufacturer In the U.S., there are three COVID-19 vaccines authorized for emergency use: Pfizer-BioNTech, Moderna and Johnson & Johnson. Verify that the vial has a maroon plastic cap and a maroon label border. 2023 Pfizer. Hospitals were filling, and no one was sure how best to treat the people who were sick. Do not administer if vaccine is discoloured or contains particulate matter. Is Pfizer working with Operation Warp Speed? Best to treat the people who were sick in your area, you. Find the Expiration date Lot Number Expiration date Lot Number found on the ability to drive and use machines <. 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