The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. In Study C4591031 (Study 4), a placebo-controlled booster study, participants 16 years of age and older recruited from Study C4591001 (Study 2) received a booster dose of COMIRNATY (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of COMIRNATY. Date on the label is NOT the expiration date Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days). b. Serious adverse events from Dose1 through up to 30 days after Dose2 in ongoing followup 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. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). 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 freeze. 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. 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. 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). Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Cardiac Disorders: myocarditis and/or pericarditis (see 7 WARNING AND PRECAUTIONS), Nervous System Disorders: Facial paralysis / Bells Palsy, hypoesthesia, paresthesia, dizziness, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema, erythema multiforme. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. These cookies may also be used for advertising purposes by these third parties. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). Not all pack sizes may be available. 09.24.22. It undergoes rigorous internal medical review and is updated regularly to reflect new information. The vaccine will be a white to off-white suspension. To report and adverse reaction, or concern about the quality of a Pfizer product, please call Pfizer 1 866 723-7111 or visit www.healthcanada.gc.ca/medeffect or call Canada Vigilance Program at 1-866-234-2345. CDC twenty four seven. 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)]. 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 reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. 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 vaccine will be an off white suspension. e. Severe: 6 or more loose stools in 24 hours. These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. Most local reactions were mild or moderate in severity. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. COMIRNATY is supplied as a frozen suspension in multiple dose vials. The FDA approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months - from six months to nine months when the vaccine is stored at a temperature of -90 to -60 degrees Celsius. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Please be mindful of when your COVID-19 vaccine expires! COMIRNATY is supplied as a frozen suspension in multiple dose vials. Do not use if liquid is discoloured or if other particles are observed. After dilution, one vial contains 10* doses of 0.2 mL. 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. 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 (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. Participants 5 Years Through12 Years of Age. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). In an analysis of all unsolicited adverse events reported following the booster dose of COMIRNATY, through 1 month after the booster dose, in participants 16 through 87 years of age (N = 5,055), adverse reactions included headache (5%), fever (4.8%), lymphadenopathy (2.8%), decreased appetite (0.2%), malaise (0.7%), nausea (0.9%), and pain in extremity (1.1%). 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 18-month shelf-life. 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. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. Anaphylaxis has been reported. The date printed on the vial and carton reflects the date of manufacture. When the current expiration date gets close, contact the manufacturer before discarding vaccine. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. 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. How can you prevent a cold chain failure? In the analysis of blinded, placebocontrolled 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. Access to this report is strictly managed by registration only. 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 Study 2, all participants 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. Refer to thawing and dose preparation instructions in the panels below. the benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. Use only this as the diluent. 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%)). After preparation, a single dose is 0.2 mL. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. 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 Do not add more than 1.3 mL of diluent. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1. b. 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). Check Your COVID-19 Vaccine Expiration Dates Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Do not discard vaccine without ensuring the expiration date has passed. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. 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. Visually inspect each dose in the dosing syringe prior to administration. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? 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. Non-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 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label 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: Each vial must be thawed and diluted prior to administration. Data.CDC.gov. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. The overall safety profile for the booster dose was similar to that seen after the primary series. The vial stoppers are not made with natural rubber latex. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. A carton of 10 vials may take up to 6 hours to thaw at this temperature. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. Refer to dilution and dose preparation instructions in the panels below. Currently available information is insufficient to determine a causal relationship with the vaccine. Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. 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%). Currently available information is insufficient to determine a causal relationship with the vaccine. 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. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). COMIRNATY multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with an orange cap and an orange label border. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. 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%). the vial has an orange plastic cap and a label with an orange border. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Contact your regional poison control centre. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C (35F to 46F) . Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Contents of the pack and other information. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). Each vial must be thawed and diluted prior to administration. There is no information on the co-administration of COMIRNATY with other vaccines. 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. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Each vial contains 6 doses of 0.3 mL. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. When at room temperature, mix by inverting vaccine vial gently 10 times. 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. Table 17: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. . The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. g. Severity was not collected for use of antipyretic or pain medication. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Do not inject the vaccine intravascularly, subcutaneously or intradermally. 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. e. Severe: requires intravenous hydration. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. Most of the additional AEs reported after 1 month post-dose up to the data cut-off date consisted of unrelated events such as spinal osteoarthritis, ischaemic stroke, breast tenderness and tooth extraction. 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: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) 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. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. 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. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. It is supplied as a frozen suspension that does not contain preservative. 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. Vials of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. 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. e. Severe: inconsolable; crying cannot be comforted. 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. "Filter Update: if you insinuate Lisa Marie Presley went into cardiac arrest because of the COVID-19 vaccine, that's an #instablock," they commented. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? The vaccine will be an off-white suspension. Verify that the vial has an orange plastic cap and an orange label border. Once vials are thawed they should not be refrozen. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. Do not pool excess vaccine from multiple vials. (See No study participants died. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. It is unknown whether this vaccine has an impact on fertility. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. In these individuals, a third dose may be considered as part of the primary series. A subsetfrom Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. Sorry, you need to enable JavaScript to visit this website. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Vials should be discarded 12 hours after dilution. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. Disclaimer Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code 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. 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. Table 17 and Table 18 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. 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. 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. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. 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. Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Overall, frequencies of any AEs reported after study vaccination up to the data cut-off date were generally similar between both vaccine groups. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU. d. Severe: causes limitation of limb movement. 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. Children 6 Months Through <2 Years of Age Primary Series (Three Doses). The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). It is unknown whether COMIRNATY has an impact on fertility. There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Each vial must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. Adjust Direction, then . 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. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. The following adverse reactions have been identified during post authorization use of COMIRNATY. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . After dilution, the vaccine will be a white to off-white suspension. pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved covid-19 vaccine, or receipt of the most recent booster dose Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . 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. They help us to know which pages are the most and least popular and see how visitors move around the site. More complete information are observed are observed vials are thawed they should be. 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