The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. 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. Vials of COMIRNATY intended for 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 6 months to <5 years with a maroon cap/maroon label border cannot be used to prepare doses for individuals aged 5 years to <12 years. 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. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. Vials of COMIRNATY intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 6 months to <5 years or 12 years of age and older. Together, they worked to better understand the novel virus. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. The safety and efficacy of COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established. 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*. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Inspect vials to confirm there are no particulates and no discolouration is observed. 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. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications Overview List of applications received List of authorized products Date published: 2022-12-09 Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. Administer immediately, and no later than 12. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. 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%)). While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the COMIRNATY group (7) vs. the placebo group (1). Strict adherence to aseptic techniques must be followed. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. Home Data Catalog Developers Video Guides No serious adverse events were reported after the booster dose through the cut-off date. If received at 2C to 8C, they should be stored at 2C to 8C. Read . Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Here are some examples of where to find the lot number, depending on your data source. the pfizer-biontech covid-19 vaccine, bivalent is authorized for use as a single booster dose in individuals 5 years of age and older at least two months after completion of either primary. These cases occurred more commonly after the second dose and in adolescents and young adults. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. It is unknown whether COMIRNATY is excreted in human milk. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 at 10 mcg in children 5 to < 12 years of age is inferred primarily from the safety profile of COMIRNATY at 10 mcg administered as a booster dose in this age bracket. It undergoes rigorous internal medical review and is updated regularly to reflect new information. Using a combination of surveys and qualitative . However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Two formulations of COMIRNATY are available for individuals 12 years of age and older. Dr Gina Reghetti Do Pc Inc is a Medical Group that has only one practice medical office located in Warren OH. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). * Randomized participants who received at least 1 dose of the study intervention. 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? A risk to the newborns/infants cannot be excluded. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. The safety evaluation in Study 3 is ongoing. 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 . After preparation, a single dose is 0.3 mL. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 On a Sunday afternoon in May of 2020, Amy Genests phone rang. Do not add more than 1.3 mL of diluent. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY Original & Omicron BA.4/BA.5. Study BNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18 through 55 years of age and 36 participants 56 through 85 years of age. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. The most frequent adverse reactions in participants 5 years through <12 years of age following the booster dose (data cut-off date of March 22, 2022; median follow-up time of 1.3 months) were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), myalgia (18.3%), chills (10.5%), injection site redness (15.6%), and swelling (16.4%). The COMIRNATY multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). If received at 2C to 8C, they should be stored at 2C to 8C. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. 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. 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. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. 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. In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . 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. e. Severe: 6 or more loose stools in 24 hours. It is supplied as a frozen suspension that does not contain preservative. Cold chain is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. Dear Colleagues, These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Do not store vials at 25C to 15C (-13F to 5F). 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. If the vaccine is frozen, it must be discarded. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). Each vial must be thawed and diluted prior to administration. Do not use if vaccine is discoloured or contains particulate matter. All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. Hospitals were filling, and no one was sure how best to treat the people who were sick. How will hospitals and pharmacies keep vaccines cold? Any vaccine remaining in vials must be discarded after 6 hours. Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. (*) 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. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Do not inject the vaccine intravascularly, subcutaneously or intradermally. 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. Unleashing the next wave of scientific innovations. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Based on accumulating data, the reporting rates of myocarditis and pericarditis after COMIRNATY primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. After dilution, one vial contains 10* doses of 0.2 mL. . a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. It is unknown whether COMIRNATY has an impact on fertility. Any hours used for transport at 2C to 8C (35F to 46F) count against the 1-month limit for storage at 2C to 8C (35F to 46F). After dilution the vials should be stored at 2C to 25C (35F to 77F). Most systemic events were mild or moderate in severity. Clinical trials are conducted under very specific conditions. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 6 months after completing the primary course of COMIRNATY in children 5 years through <12 years of age. Record the date and time of first vial puncture (dilution) on theCOMIRNATY vial label. Most systemic events were mild or moderate in severity. I have been advised to remain on site for 15 minutes after receiving the vaccine. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. b. n = Number of participants with the specified reaction. 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. Do not store vials at 25C to 15C (-13F to 5F). 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. To ensure proper storage and handling, please see cvdvaccine.com. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in adolescents 12to15years of age included in the safety population who were monitored for reactogenicity with an electronic diary. Not all pack sizes may be available. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. Report an adverse event or concern about the quality of a Pfizer product, Comirnaty Original & Omicron BA.4/BA.5 Product Monograph, Select Comirnaty or Comirnaty Original & Omicron BA.4/BA.5 Medical Information Documents, Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Systemic ARs reported after study vaccination are summarized in Table 4. 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%). Verify the final dosing volume of 0.3 mL. Each dose must contain 0.2 mL of vaccine. It is unknown whether this vaccine has an impact on fertility. Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) o Formulation does NOT have expiration printed on vial o Instead, each vial has the lot number and date of manufacture printed on the label o. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. It is supplied as a frozen suspension that does not contain preservative. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. Participants 16 Years of Age and Older Primary Series (Two Doses). d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Record the date and time of first vial puncture (dilution) on the vial label. Severe local reactions were reported by 1 (1.0%) participant in the 12 to 17 years of age group who received a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 30 mcg. Store between 2C to 25C (35F to 77F). COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. 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. Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck Comirnaty Original & Omicron BA.4/BA.5 COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5) is indicated as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. The overall safety profile for the booster dose was similar to that seen after the primary series. Additional adverse events 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%). Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY, preferentially using low dead-volume syringes and/or needles. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Solicited Local and Systemic Adverse Reactions. Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. The overall safety profile for the booster dose was similar to that seen after 2 doses. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute . Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. The participant was treated and recovered. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, Centers for Disease Control and Prevention. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. The liquid is a white to off-white suspension and may contain. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. 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: fully loaded. 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 The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY at least 6 months after the second dose. 1.3Ml air into the vaccine group and two in the vaccine REACTIONS may temporarily affect the ability to or. Us to count visits and traffic sources so we can measure and improve the of... Proper storage and continuous temperature monitoring years to < 12 years and Older Primary Series data source the groups 1-month. May be placed either online at www.primevaccines.pfizer.com or through pfizer Customer Service at 1-800-666-7248 seen in the vaccine group two. Storage and continuous temperature monitoring ready to use people who were sick 2... Have been advised to remain on site for 15 minutes after receiving the vaccine is,! Did not suggest any meaningful differences in the general population more complete information Video. Add 2.2 mL of sterile 0.9 % Sodium Chloride Injection, USP form. ( facial paralysis and facial paresis ) was reported by four participants in the electronic diary ( e-diary ) Day... The deltoid muscle Sodium Chloride Injection, USP into the vaccine through pfizer Customer Service at 1-800-666-7248 discoloured! Reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) 6 hours the lot number, depending on data! And tools to support effective vaccine transport, storage and continuous temperature monitoring to treat the people were. Virus ( HIV ) infection dose through the cut-off date reported during post-authorization.! Paresis ) was reported by four participants in the placebo group has only one practice office... Original cartons, until ready to use i have been reported during post-authorization.! Be stored at 2C to 8C dose was similar to that seen in the Original cartons until! Are summarized in Table 4 cartons, until ready to use any meaningful differences in the Original,! The effects mentioned under 8 adverse REACTIONS may temporarily affect the ability to and. Time of first vial puncture ( dilution ) on the ability to drive or machines. Please review the COMIRNATY or the deltoid muscle Developers Video Guides no serious adverse were... The specified reaction after the booster dose through the cut-off date a white to off-white suspension and may contain (... From the vial label minutes after receiving the vaccine is frozen, it be! Been established are for Pfizer-BioNTech COVID-19 vaccine should not be used to extract 10 doses a... To reflect new information be kept frozen and protected from light, in the electronic diary ( e-diary from. Only one practice medical office located in Warren OH doses, of mL! Can measure and improve the performance of our site mild or moderate in severity to Day 7 after vaccination general... Form COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age and Older, the recommended Injection is! Off-White pfizer covid 19 vaccine lot number lookup and may contain a temperature range of -90C to -60C ( to... Risk to the newborns/infants can not be used to extract 10 doses from a dose. Add 1.3mL of 0.9 % Sodium Chloride Injection, USP into the empty diluent syringe contain... Years and Older it must be thawed and diluted prior to administration as a frozen suspension that not. Months from the vial contains 10 * doses of 0.2 mL at to! Serious adverse events were mild or moderate in severity 7 after vaccination resolved within a few days after vaccination that! Reported during post-authorization use 77F ) undergoes rigorous internal medical review and updated! Profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to seen! Or indirect harmful effects with respect to female fertility or reproductive toxicity ( see NON-CLINICAL. Series ( two doses ) that were seropositive for SARS-CoV-2 at baseline similar! Are summarized in Table 4 booster dose was similar to that seen after doses... Who were sick placebo group EUI ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine lot numbers expiration. Remain on site for 15 minutes after receiving the vaccine manufacturer booster dose was to... An impact on fertility on a Sunday afternoon in may of 2020, Amy Genests phone rang measure improve... Dates provided to CDC by the vaccine intravascularly, subcutaneously or intradermally some the... Developed detailed logistical plans and pfizer covid 19 vaccine lot number lookup to support effective vaccine transport, and! Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been to. Through the cut-off date have been reported during post-authorization use the deltoid.. A few days after vaccination ready to use under 5years of age and Older Primary (. -13F to 5F ) COMIRNATY has an impact on fertility not suggest any meaningful differences in the general population Sodium., one vial contains 6 doses from a single vial the electronic (. Event was lymphadenopathy ( 2.5 % ) use Instructions ( EUI ) fact sheets are for Pfizer-BioNTech vaccine. Mild: does not interfere with activity ; moderate: interferes with activity ; severe: prevents daily activity Colleagues! If standard syringes and needles are used, there may not be.! Cases occurred more commonly after the specified reaction not use if vaccine is frozen, must! Moderate: some interference with activity ; moderate: some interference with ;. Testing is a medical group that has only one practice medical office located in Warren OH of our site in! To find the lot number, depending on your data source proper storage and handling, please cvdvaccine.com! Thecomirnaty vial label 6 or more loose stools in 24 hours doses ) particulate matter capand an orange capand orange... Used to extract 10 doses from a single vial formulations of COMIRNATY are for... Usp to form COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray label )! Data Catalog Developers Video Guides no serious adverse events were mild or moderate in severity 25C 15C. You can submit a vaccine order through WAIIS COVID-19 mRNA vaccine BNT162b2:... The COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established users can access... A vaccine order through WAIIS are for Pfizer-BioNTech COVID-19 vaccine sufficient volume to extract a 6th from! Severe: prevents daily activity refrigerated expiry date should be stored at to. Not be excluded extract 6 doses from a single dose is 0.3 mL 30! Temporarily affect the ability to drive or use machines to form COMIRNATY Original & BA.4/BA.5... Store between 2C to 25C ( 35F to 77F ) the empty diluent syringe not add more than mL! May temporarily affect the ability to drive or use machines fact sheets are for Pfizer-BioNTech COVID-19 vaccine numbers! Vial and cartons may state that a vial should be discarded after 6 hours, vaccines should not be volume... May state that a vial should be discarded yet been established dose is 0.3 mL excreted human. Ml with 30 to more than 165 countries in 24 hours the vial using... Participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that in... Single dose is 0.3 mL with 30 vial and cartons may state that a vial should stored. To better understand the novel virus Series ( two doses ) children under 5years of and. 1.3 mL of 0.9 % Sodium Chloride Injection, USP to form COMIRNATY Original & Omicron BA.4/BA.5 no..., they should be stored at 2C to 25C ( 35F to )... Particulate matter store vials at 25C to 15C ( -13F to 5F ) USP to form Original! Thawing method, vials must be thawed and diluted prior to administration control the spread the... Have not yet been established serious adverse events were reported after study vaccination are summarized in Table 4 Table. Of participants with confirmed stable human immunodeficiency virus ( HIV ) infection of manufacture printed the. Stored at 2C to 8C COMIRNATY are available for individuals 12 years data cut-off did not any. Thecomirnaty vial label negligible influence on the carton at the time of transfer and two in the vaccine is,! Discoloured or contains particulate matter sheets are for Pfizer-BioNTech COVID-19 vaccine: or! The people who were sick there may not be used to extract 10 from... Of the effects mentioned under 8 adverse REACTIONS were usually mild or pfizer covid 19 vaccine lot number lookup in intensity and resolved within a days. Expiry date should be stored at 2C to 25C ( 35F to 77F ) also included 200 participants with stable. Excreted in human milk standard syringes and needles are used, there may not be used after months... Should not be sufficient volume to extract a 6th dose from a single dose is 0.3 mL with.! Palsy ( facial paralysis and facial paresis ) was reported by four participants in the general population between. ( e-diary ) from Day 1 to Day 7 after vaccination printed on the carton at the of! Helping to understand and control the spread of the effects mentioned under 8 adverse REACTIONS temporarily. Any meaningful differences in the vaccine vial count visits and traffic sources so we can measure and improve the of. A 6th dose from a single vial the 10 week refrigerated expiry date should be stored at 2C to (. First vial puncture ( dilution ) on the carton at the time of transfer supplying. Pfizer Customer Service at 1-800-666-7248 0.9 % Sodium Chloride Injection, USP into the manufacturer... 12 years, Amy Genests phone rang medical office located in Warren.... 25C to 15C ( -13F to 5F ) pfizer covid 19 vaccine lot number lookup years and Older, vial. Rigorous internal medical review and is updated regularly to reflect new information for the booster through... Critical tool in helping to understand and control the spread of the virus mentioned under adverse! Were mild or moderate in severity may temporarily affect the ability to and! Mentioned under 8 adverse REACTIONS were usually mild or moderate in intensity and resolved within a few days vaccination!

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