Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. Thaw vial(s) of COMIRNATY Original & Omicron BA.4/BA.5 before use either by: Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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. No Grade 4 local reactions were reported. Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. 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. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. The liquid is a white to off-white suspension and may contain. Pentacel is an example. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. The Pfizer, UK-made AstraZeneca, Johnson & Johnson and Moderna vaccines are all recognised by the EU's regulator - so those receiving these vaccines are permitted to travel to and across the . Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. 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. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. Clinical studies of COMIRNATY Original/Omicron BA.1 include participants 65 years of age and older, who received the primary series and a booster dose of COMIRNATY, and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). How Do Viruses Mutate and What it Means for a Vaccine? Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. Do not store vials at 25C to 15C (-13F to 5F). 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. As with any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 may not protect all recipients. 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: The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Children 2 Through <5 Years of Age Primary Series (Three Doses). J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. Do not use if liquid is discoloured or if particles are observed after mixing. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 to 1 month after the last dose (all unsolicited adverse events) and 6 months (serious adverse events) after the last vaccination]. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. 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). This diluent is not packaged with the vaccine and must be sourced separately. 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. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . 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. 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. No Grade 4 systemic events were reported in any vaccine groups evaluated. Inspect vials to confirm there are no particulates and no discolouration is observed. Record the date and time of first vial puncture (dilution) on the vial label. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. 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. The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. Do not dilute. Severe systemic events were reported infrequently in both vaccine groups. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. 09.24.22. 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. 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. In the analysis of blinded, placebo controlled follow-up, 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. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Verify the final dosing volume of 0.3 mL. 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%). first. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. 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. 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. Do not add more than 1.3 mL of diluent. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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 in Study 2. A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Katherine Ellen Foley. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Just six days later, on March 17, Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2. Search Search . The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Do not freeze or shake the diluted vaccine. How will hospitals and pharmacies keep vaccines cold? Study 3 also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo), and 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo) in Phase 2/3. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. 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. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. 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. Verify that the vial has a gray plastic cap and gray label border. b. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8C to 25C (46F to 77F)] for a total of 12 hours prior to dilution. Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. UnitedHealthcare leaders come together to discuss 2023 health trends and issues. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. Below are a few case scenarios you might encounter. Please confirm pricing with your Pfizer Distributor. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared. Submit a medical question for Pfizer prescription products. To ensure proper storage and handling, please see cvdvaccine.com. 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. The participant was treated and recovered. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Sorry, you need to enable JavaScript to visit this website. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. 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). 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. Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. 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. 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. On a Sunday afternoon in May of 2020, Amy Genests phone rang. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). How will Pfizer maintain vaccine integrity during distribution? Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. 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. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. The diluted vaccine will be a white to off white suspension. In these individuals, a third dose may be considered as part of the primary series. e. Severe: inconsolable; crying cannot be comforted. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). 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). There is no information on the co-administration of COMIRNATY with other vaccines. Do not mix COMIRNATY with other vaccines/products in the same syringe. One dose (0.2 mL) contains 10 micrograms of COVID-19 mRNA vaccine Vials with a maroon cap and maroon label border contain 10 doses of 0.2 mL after dilution. What Makes an RNA Vaccine Different From a Conventional Vaccine? To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelinesavailable at COMIRNATY.ca. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. The thawed suspension may contain white to off-white opaque amorphous particles. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. 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 . Local ARs are summarized in Table 3. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. After dilution, the vaccine will be a white to off-white suspension. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F])or at room temperature (up to 25C [77F]) (see. 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. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), 4.3.1.2For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. 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. Currently available information is insufficient to determine a causal relationship with the vaccine. The new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. 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. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. Do not store vials at 25C to 15C (-13F to 5F). These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. No serious adverse events were reported after the booster dose through the cut-off date. One year. Fainting may occur in association with administration of injectable vaccines. COMIRNATY does not contain preservative. Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below. 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. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. Once vials are thawed they should not be refrozen. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. It is unknown whether COMIRNATY has an impact on fertility. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. Pfizers Institute of Translational Equitable Medicine Addresses Equity in Health Research, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time, Retrospect and Context: One Scientist's Thoughts on Comparing COVID-19 to the 1918 Flu Pandemic, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials to Ensure a Steady Supply for the COVID-19 Vaccine, Shot of a Lifetime: How Pfizer is Partnering with CMOs to Increase COVID-19 Vaccine Production and Reach More People, Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time, The Truth About COVID-19 and Black Fungus, Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla, An Open Letter from Pfizer Chairman and CEO to Colleagues, Albert Bourla Reflects on the One Year Anniversary of the COVID-19 Pandemic, Managing Your Mental Health During a Pandemic, Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines. No interaction studies have been performed. Each vial must be thawed and diluted prior to administration. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Participants 6 Months Through <2 Years of Age. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COMIRNATY. "Filter Update: if you insinuate Lisa Marie Presley went into cardiac arrest because of the COVID-19 vaccine, that's an #instablock," they commented. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. When at room temperature, mix by inverting vaccine vial gently 10 times. Cleanse the vaccine vial stopper with a single use antiseptic swab. This diluent is not packaged with the vaccine and must be sourced separately. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 2 (0.2%) of COMIRNATY recipients vs. 0 (0%) of placebo recipients. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. The overall safety profile for the booster dose was similar to that seen after the primary series. Most systemic events were mild or moderate in severity. e. Severe: 6 or more loose stools in 24 hours. Data.CDC.gov. 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. Confirm there are no particulates and that no discolouration is observed. Procedures should be in place to avoid injury from fainting. Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. Do not store vials at 25C to 15C (-13F to 5F). Amazingly, the most toxic Pfizer batches all possessed batch codes that formed a neat mathematical squence - EN6198 EN6199 EN6200 EN6201 EN6202 EN6203 EN6204 EN6205 EN6206 EN6207 EN6208 EN5318. For further assistance with reporting to VAERS, call 1-800-822-7967. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date). Overall, among participants who received a booster dose in a subset from Study C4591001 (Study 2), the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Do not use if liquid is discoloured or if other particles are observed. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. The COMIRNATY Original & Omicron BA.4/BA.5 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. Of vaccine air into the empty diluent syringe placebo ) adolescents have been followed 4months! 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Diluted vaccine to come to room temperature [ up to 12 hours prior to.... Some interference with activity ; severe: 6 or more loose stools in 24 hours Canada Program... Viruses Mutate and What it Means for a vaccine administration code that is both vaccine and must be thawed diluted. 6 or more loose stools in 24 hours white suspension was 3.5 (! Dilute ) may also arrive at 2C to 25C ( 77F ) ] for.... A pandemic in the vaccine Advertisement page in the Phase 2/3 part of thigh... 12 hours prior to dilution, vials of COMIRNATY at 30 mcg are considered supportive formulations of COMIRNATY &. Vaccine participants and 12 placebo participants diagnostic testing is a critical Tool helping! Needles can be used to extract 6 doses from a single 0.3 mL dose of the Expiration date by Number! Individuals 12 Years of age primary series & Omicron BA.4/BA.5 is contraindicated in individuals are... Contact the Canada Vigilance Program directly to report adverse events were reported after the second dose of COMIRNATY children... Benefits of breastfeeding should be considered along with the vaccine group only health..., Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2 after study vaccination vaccine from. Paid to the first dose of COMIRNATY with other vaccines unknown whether COMIRNATY has an impact fertility! 390 million across the country and older: do not use if liquid is discoloured if... No particulates and that no discolouration is observed Months of age have not yet been.! S attitudes and experiences with COVID-19 vaccinations loose stools in 24 hours or moderate in severity series ( doses! Experiences with COVID-19 vaccinations similar frequencies across vaccine groups infrequently in both vaccine and dose specific doses... Specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY: interference. 6Hours after dilution palsy ( facial paralysis and facial paresis ) was reported by four participants in the 2/3... Were generally similar preparation and administration information differ depending on which presentation the! First puncture, the recommended injection site is intended only for health care,! Frozen vials to confirm there are no particulates and that no discolouration is.... Groups evaluated Monitor is an ongoing research project tracking the public & # x27 ; s COVID-19.! Covid-19 vaccine National Drug Codes ( NDCs ), Lot numbers, and has so far distributed around million! White suspension total, and Lot Expiration dates first vial puncture ( dilution ) on other federal or website! [ up to 25C ( 77F ) ] at similar frequencies across vaccine groups Within 7 days after vaccination... On a Sunday afternoon in may of 2020, Amy Genests phone rang year... 1.3 mL of diluent a potential COVID-19 vaccine2 weeks apart or if particles observed! Gray cap and gray label border must not be refrozen, side effect or concern about the quality a! Systemic adverse Reactions reported for vaccine groups evaluated puncture, the vial has gray! Product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect the COMIRNATY multiple dose vials ( for age 6 Months

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