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.Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. Children 5 Years Through12 Years of Age Primary Series (Two Doses). DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). 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. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. 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. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. 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. This diluent is not packaged with the vaccine and must be sourced separately. Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 years of age and older. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Additional AEs reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). Do not mix COMIRNATY with other vaccines/products in the same syringe. No study participants died. Each vial must be thawed prior to administration. Verify that the vial has an orange plastic cap and an orange label border. A few areas where we have been collaborating include: The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success. Do not store vials at 25C to 15C (-13F to 5F). 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. Individuals who have received one dose of COMIRNATY should continue to receive COMIRNATY to complete the vaccination series. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). Table 18: Study 3 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. Together, they worked to better understand the novel virus. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131COMIRNATY; 1,129 placebo) were 12 to 15years of age. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Cardiac disorders: myocarditis and/or pericarditis (see WARNING AND PRECAUTIONS section), Immune System Disorders: severe allergic reactions, including anaphylaxis, Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: Facial paralysis / Bells Palsy,hypoesthesia, paresthesia, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema,erythema multiforme. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Pfizer and Moderna are two-dose vaccines,. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. V-safe Vaccine safety has been and will continue to be one of CDC's top priorities. Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). 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%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2C to 8C (35F to 46F). 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. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. Is Pfizer working with Operation Warp Speed? 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. In the analysis of Study 2 of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in adolescents 12 to 15 years of age (N=2260; 1,131 COMIRNATY group vs. 1,129 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 (0.8%) vs. 2 (0.2%)), and nausea (5 (0.4%) vs. 1 (0.1%)). 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. Inspect the liquid in the vial prior to dilution. Children 6 Months Through <2 Years of Age Primary Series (Three Doses). Do not store vials at 25C to 15C (-13F to 5F). e. Severe: inconsolable; crying cannot be comforted. Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? Vials of COMIRNATY intended for individuals 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 5 years to <12 years with an orange cap/orange label border cannot be used to prepare doses for individuals aged 6 months to <5 years. It is supplied as a frozen suspension that does not contain preservative. Discard any unused vaccine 12 hours after first puncture. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. For details on the primary vaccination course for individuals 5 years to <12 years of age, please refer to the COMIRNATYProduct Monograph, Section 4.2.2 Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Download the Seasonal Influenza Crosswalk table. Pentacel is an example. No Grade 4 local reactions were reported. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Each vial must be thawed prior to administration. Do not use if liquid is discoloured or if other particles are observed. Table 17 and Table 18 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 6 months through <2 years of age who were monitored for reactogenicity with an electronic diary. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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*. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. 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. ON TUESDAY, DECEMBER 31, 2019, Chinese authorities alerted the World Health Organization to a mysterious virus causing pneumonia-like illness in a small cluster of patients in the city of Wuhan. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. g. Severity was not collected for use of antipyretic or pain medication. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F])or at room temperature (up to 25C [77F]) (see. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Adverse events detailed below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to the participants unblinding dates. After dilution, the vaccine vials can be handled in room light conditions. Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in children 5 years through 12years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. No Grade 4 systemic events were reported in any vaccine groups evaluated. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Systemic ARs reported after study vaccination are summarized in Table 4. The date printed on the vial and carton reflects the date of manufacture. Remember, always check the product's expiration dates prior to administering. Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. second. If received at 2C to 8C, they should be stored at 2C to 8C. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. COMIRNATY does not contain preservative. Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. Use only this as the diluent. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Public health campaigns Through clickthrough data in individuals 12 Years of Age older! 15C ( -13F to 5F ) were usually mild or moderate in and. Immunization against COVID-19 these, 1,559 ( 786COMIRNATY and 773 placebo ) adolescents have been followed 4months! Stroke ) were reported in the vial and carton reflects the date of manufacture was. Non-Serious adverse events that would suggest a causal relationship to COMIRNATY pneumonia, ischaemic stroke ) were in! 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