Inspect vials to confirm there are no particulates and no discolouration is observed. Do not use if vaccine is discoloured or contains particulate matter. Record the date and time of first vial puncture (dilution) on theCOMIRNATY vial label. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. 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 . The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. Participants 5 Years Through <12 Years of Age. Each component vaccine of a multiple component vaccine will have a unique NDC which also differs from the NDC of the unit of sale. Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. Non-serious adverse events from Dose1 through up to 30days after Dose2 in ongoing followup in the initial enrolment group were reported by 10.9% of COMIRNATY 10mcg recipients and by 9.1% of placebo recipients. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. Vials must reach room temperature before dilution. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. The participant was treated and recovered. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. 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. 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. 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. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Currently available information is insufficient to determine a causal relationship with the vaccine. Participants 5 Years Through12 Years of Age. 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. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. Procedures should be in place to avoid injury from fainting. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The following adverse reactions have been identified during post authorization use of COMIRNATY. Gently invert the vial containing COMIRNATY 10 times to mix. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. The overall safety profile for the booster dose was similar to that seen after 2 doses. An Open Letter from Albert Bourla to Pfizer Employees 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 . For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. 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. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. Table 17: Study 3 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. 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. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. b. n = Number of participants with the specified characteristic. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Irrespective of the type of syringe and needle: COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. This Fact Sheet describes Emergency Use Instructions that . Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Most systemic events were mild or moderate in severity. Do not store vials at 25C to 15C (-13F to 5F). b. As the weather cools, viruses have a tendency to spread with more ease. Katherine Ellen Foley. 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. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting. 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. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). 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. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. (See The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Vials should be discarded 12hours after first puncture. 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. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). 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: A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 years of age and older. 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. Hospitals were filling, and no one was sure how best to treat the people who were sick. 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. COVID-19 Vaccine Lot Number and Expiration Date Tool. Once vials are thawed they should not be refrozen. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Tables 7 through 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in the subset of participants 16 years of age and older (n=9,839) in the safety population who were monitored for reactogenicity with an electronic diary. d. Severe: disabling; not interested in usual daily activity. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Do not discard vaccine without ensuring the expiration date has passed. A risk to the newborns/infants cannot be excluded. 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). Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). 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. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - 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. Table 13: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*, Table 14: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. 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. Visually inspect each dose in the dosing syringe prior to administration. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. What Makes an RNA Vaccine Different From a Conventional Vaccine? Not all pack sizes may be available. After your first vaccine, you should have been given a card titled 'My Personal COVID-19 Vaccine Record Card' with your name, date of birth, the vaccine name and the date you received the vaccine . Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between 90C to -60C (-130F to -76F) until the expiry date printed on the label. 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). If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. 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). COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. Our scientific content is evidence-based, scientifically balanced and non-promotional. Pentacel is an example. 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. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals 12 years of age and older (gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 to <12 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. 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 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. In a clinical study with a data cut-off date of 02 September 2021, the most commonly reported (8%) adverse reactions in adolescents 12 through 15 years of age following any dose were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%). 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. In the analyses of Study 3 in participants 2 through <5 years of age (606 COMIRNATY; 280 placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C (130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). 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. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. These cases occurred more commonly after the second dose and in adolescents and young adults. 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) fully loaded. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. 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. Shortly after, the novel virus was identified as SARS-CoV-2. 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. 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? The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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 new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. Each vial must be thawed prior to administration. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. 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. A risk to the newborns/infants cannot be excluded. 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. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Store between 2C to 25C (35F to 77F). 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. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 12 years of age and older is inferred from safety data from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age and also safety data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection,USP prior to use. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. The vial stoppers are not made with natural rubber latex. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. Local ARs are summarized in Table 5. Disclaimer Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . Participants continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. Do not store vials at 25C to 15C (-13F to 5F). If the vaccine is frozen, it must be discarded. 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. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. first. To prevent vaccine from inadvertently being discarded, providers . Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. During the visual inspection: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. f. Severe: 6 or more loose stools in 24 hours. 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. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. Cleanse the vaccine vial stopper with a single-use antiseptic swab. 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. After dilution the vials should be stored at 2C to 25C (35F to 77F). There is no information on the co-administration of COMIRNATY with other vaccines. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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). Table 3: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, COMIRNATY Original & Omicron BA.4/BA.5 (15 mcg/15 mcg), Solicited Systemic Adverse Reactions (ARs). Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 2. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. a second dose inventory management system. Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in children 5 years through 12years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. 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. No deaths related to the vaccine were reported in the study. Enfermedad por coronavirus (COVID-19) Situacin. 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. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. 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. 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%). Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. Table 7: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 8: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 9: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Table 10: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Study 2 also included 200 participants with confirmed stable human immunodeficiency virus. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. The overall safety profile for the booster dose was similar to that seen after 2 doses.
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