People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. (5 Through 11 Years of Age/16 Through 25 Years of Age)*,, 10 mcg/Dose A descriptive summary of seroresponse to the Original strain is also included in Table 39. Demographic characteristics in Study 3 were generally similar with regard to age, gender, race, and ethnicity among participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and those who received placebo. COMIRNATY and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved monovalent COVID-19 vaccines. Data have not been submitted to FDA on administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time as other vaccines. First COVID-19 occurrence from 7 days after Dose 2 in participants 12 through 15 years of age without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 Vaccine Participants are being monitored for unsolicited adverse events through 1 month after vaccination and for serious adverse events for 6 months after the last vaccination. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. In an analysis of a subset from Study 4, a total of 610 participants greater than 55 years of age who had previously received a 2-dose primary series and 1 booster dose with Pfizer-BioNTech COVID-19 Vaccine received 1 of the following as a second booster dose: Pfizer-BioNTech COVID-19 Vaccine or bivalent vaccine (Original and Omicron BA.1). There is currently an outbreak of COVID-19 caused by SARS-CoV-2. Table 17 and Table 18 present the frequency and severity of reported solicited local reactions and systemic reactions, respectively, within 7 days of a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Immunogenicity analyses have been performed in the immunobridging subset of 143 Study 3 participants 2 through 4 years of age without evidence of infection up to 1 month after Dose 3 based on a data cutoff date of April 29, 2022. n (%). A comparison of seroresponse rates to the Original strain was descriptive. n1 Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for injection. Superiority of the anti-Omicron BA.1 NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2-sided 95% CI for GMR was >1. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) suspension for injection, for intramuscular use. What is added by this report? Pfizer-BioNTech COVID-19 Vaccine Administered as a First Booster Dose Following a Primary Series of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) in Participants 18 through 55 Years of Age. First Booster Dose Following a Primary Series of Pfizer-BioNTech COVID-19 in Participants 5 Through 11 Years of Age. But those aged 12-18 can only opt for BA.4/5 bivalents. Among 1,161,704 SARS-CoV-2 PCR tests linked to COVID-19 vaccination status, there were 390,467 SARS-CoV-2 PCR confirmed positive tests during Delta variant predominance and 212,433 SARS-CoV-2 positive tests during Omicron variants BA.1 and BA.2 predominance. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, the Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA), more commonly in adolescent males and adult males under 40 years of age than among females and older males. We comply with the HONcode standard for trustworthy health information. Performance & security by Cloudflare. Among the 4,647 participants 5 through 11 years of age who received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) or placebo, 51.8% were male and 48.2% were female, 77.3% were White, 5.8% were Black or African American, 16.9% were Hispanic/Latino, 8.3% were Asian, and 0.4% were American Indian/Alaska Native. February 13, 2023 COVID-19 Infectious Diseases Vaccines When vaccines for COVID-19 rolled out in late 2020, people of all ages rushed to get in line. When you, or your child, receive the first COVID-19 vaccine, you will get a vaccination card. Overall, among the participants who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. Individuals ages 6 years and older who have already received an updated mRNA vaccine do not need to take any action unless they are 65 years or older or . No serious adverse events were reported in the 36 participants 2 through 4 years of age from the study vaccination through 1 month post vaccination. above). Do not administer Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Description (11)]. Surveillance Time (n2#), Placebo All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The primary immunobridging analyses compared the geometric mean titers (using a GMR) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 3 in participants 6 through 23 months of age and up to 1 month after Dose 2 in participants 16 through 25 years of age. If local redistribution is needed, single dose vials and multiple dose vials may be transported at -90C to -60C (-130F to -76F) or 2C to 8C (35F to 46F). Results from participants 6 months through 4 years of age are presented in this subsection. Ensure staff are knowledgeable about correct storage of the vaccines. 16 Through 25 Years of Age But the critical question is, who was getting hospitalized? The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent under an EUA. SARS-CoV-2 NT50 were compared between an immunogenicity subset of Phase 2/3 participants 2 through 4 years of age from Study 3 at 1 month after the 3-dose primary series and a randomly selected subset from Study 2 Phase 2/3 participants 16 through 25 years of age at 1 month after the 2-dose primary series, using a microneutralization assay against the reference strain (USA_WA1/2020). For use under Emergency Use Authorization. Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised; therefore, you or your child should continue to maintain physical precautions to help prevent COVID-19. April 2023). For use under Emergency Use Authorization. In the expansion cohort from Dose 1 through the cutoff date, lymphadenopathy was reported in 6 (0.4%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 3 (0.4%) in the placebo group. Regardless of storage condition, the vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a vaccine for use in individuals 6 months of age and older to prevent COVID-196. Safety surveillance data from the Ministry of Health of Israel on the administration of approximately 700,000 fourth doses of the Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) given at least 4 months after the third dose in participants 18 years of age and older (approximately 600,000 of whom were 60 years of age and older) revealed no new safety concerns. Participants 12 Through 15 Years of Age (2-Dose Primary Series). (1 Month After Dose 2) Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Study 6 (NCT05543616) enrolled participants 6 months through 11 years of age to receive a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Everyone aged 6 years and older You are up to date when you get 1 updated Pfizer-BioNTech or Moderna COVID-19 vaccine. Individuals 5 through 11 years of age: vials with orange caps and labels with orange borders, a single dose is 0.2 mL. In the evaluable efficacy population, 8.7% of vaccine recipients had one or more comorbidities that increase the risk of severe COVID-19 as described in the Morbidity and Mortality Weekly Report (MMWR) 69(32);1081-8 and/or obesity (BMI 95th percentile) for participants 2 through 4 years of age. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is highest in males 12 through 17 years of age. WHAT IF I AM, OR MY CHILD IS, IMMUNOCOMPROMISED? In the evaluable immunogenicity population (regardless of evidence of prior infection), 6/132 participants (4.5%) were baseline positive for prior SARS-CoV-2 infection. Individuals 12 years of age and older: vials with gray caps and labels with gray borders, a single dose is 0.3 mL. Pfizer is the initially approved brand for Bivalent vaccines. The updated bivalent COVID-19 booster shots will likely provide immunity lasting up to four to six monthssimilar to what earlier shots offered. The vaccine efficacy results after Dose 3 in participants 6 months through 4 years of age are presented in Table 34. In participants who received the bivalent vaccine (Original and Omicron BA.1), the mean duration of injection site pain, redness, and swelling was 2.2 days (range 1 to 12 days), 2.9 days (range 1 to 10 days), and 1.9 days (range 1 to 4 days), respectively. The evaluable immunogenicity population without prior evidence of SARS-CoV-2 infection up to 1 month after Dose 3 of Pfizer-BioNTech COVID-19 Vaccine was comprised of 82 participants 6 through 23 months of age. The 305 participants greater than 55 years who received a second booster dose with Pfizer-BioNTech COVID-19 received it 5.3 to 13.1 months after receiving the first booster dose and had a median follow-up time of 1.8 months up to a data cutoff date of May 16, 2022. n1 Experience with other vaccines has shown that the way our bodies develop protection, known as an immune response, and possible side effects after getting vaccinated are generally the same when given alone or with other vaccines. Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). In Phase 2/3, a total of 1,776 participants 6 through 23 months of age and 2,750 participants 2 through 4 years of age were randomized 2:1 and received 3 doses of the Pfizer-BioNTech COVID-19 Vaccine or saline placebo. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Hi, my name is Paul Offit. 2 Through 4 Years of Age If you are not able to access the bivalent COVID-19 vaccine, apply for a temporary postponement through Vax Viewer. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 participants (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. In 1 group of participants (initial enrollment cohort) with a median of 2.3 months follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination. The descriptive vaccine efficacy results in participants 5 through 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 27. New Moderna Omicron Covid Booster Explained - Bloomberg Business Prognosis What You Need to Know About Moderna's New 'Bivalent' Covid Vaccine The shot. For use under Emergency Use Authorization. Among the 12 Phase 1 participants 65 through 85 years of age, the median age was 69 years (range 65 through 75 years of age), 6 were male and all were White and Not Hispanic/Latino. Local and systemic adverse reactions and use of antipyretic medication were solicited in an electronic diary for 7 days following each injection (i.e., day of vaccination and the next 6 days) among participants receiving bivalent vaccine (Original and Omicron BA.1) and participants receiving Pfizer-BioNTech COVID-19 Vaccine. The mean duration of pain at the injection site after Dose 3 was 1.7 days (range 1 to 14 days), for redness 1.5 days (range 1 to 3 days), and for swelling 1.8 days (range 1 to 4 days) for participants 2 through 4 years of age in the Pfizer-BioNTech COVID-19 Vaccine group in the blinded placebo-controlled follow-up period (cutoff date of April 29, 2022). You may also be given an option to enroll in v-safe. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow-up were reported by 29.1% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 26.3% of placebo recipients. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. It is important that the information reported to FDA be as detailed and complete as possible. Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The bivalent vaccine is authorized for emergency use in people ages 5 and older. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. In an analysis of Study 3 (Phase 2/3), based on data in the blinded placebo-controlled follow-up period up to the cutoff date of April 29, 2022, 886 participants 2 through 4 years of age who received a 3-dose primary series [606 Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA); 280 placebo] have been followed a median of 1.4 months after the third dose. All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. For age 5 years to < 12 years WHAT ARE THE BENEFITS OF PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? Vaccines and diluents must be unpacked, stored at recommended temperatures, and documented immediately after arrival. Overall, the 401 participants who received a first booster dose of Pfizer-BioNTech COVID-19 Vaccine had a median follow-up time of 1.3 months after the booster dose through the cutoff date. This analysis showed no evidence of an increased risk of stroke in the 21 days immediately after vaccination with either of the 2 mRNA COVID-19 bivalent BA.1 vaccines in England, with similar results for ischemic and hemorrhagic stroke and for the subset aged 65 years and older given influenza vaccine on the same day as the bivalent COVID-19 . This authorization is based on safety and effectiveness data with Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the bivalent vaccine (Original and Omicron BA.1). Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. The following adverse reactions have been identified during post-authorization use of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. And later they did a study showing that if you receive four doses, you were less likely to be hospitalized than those who received three doses. Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the . The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). N=1660 Lancet Infectious Diseases. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not licensed for any use. Epidemiologist Keri Althoff answers these questions and more. BioNTech Manufacturing GmbH Abbreviations: CI = confidence interval; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. The safety of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months of age and older is based on: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. In a second group of participants (expansion cohort) with a median of 2.4 weeks follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination. Dose 1 Discard after single use. The median age was 16.0 months in vaccine recipients 6 through 23 months of age and the median age was 3.0 years in vaccine recipients 2 through 4 years of age. N=1097 Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 Vaccine NACI posted the new interim guidance . Privacy Policy| Among the vaccine recipients, 51.1% were female. n (%). Related Centers and Programs: 1. Participants received a booster (fourth dose) with Pfizer-BioNTech COVID-19, Bivalent 2.6 to 8.5 months after receiving their third dose with Pfizer-BioNTech COVID-19 Vaccine and had a median follow-up time of 1.6 months (range 1.1 to 2.3 months) up to a data cutoff date of November 25, 2022. Pfizer-BioNTech COVID-19 Vaccine Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for up to 10 weeks. --------DOSAGE FORMS AND STRENGTHS-------- For intramuscular use. A bivalent vaccine elicits an immune response against two different antigens. The duration of protection against COVID-19 is currently unknown. There were 15.9% Hispanic/Latino participants. For individuals with certain kinds of immunocompromise 5 years of age and older, a single additional age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individuals clinical circumstances. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. The current COVID-19 vaccines and boosters target the original type of COVID-19 discovered in late 2019. In this study, participants who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of 1 of 3 vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine. The data must show that the vaccines are safe and effective before the FDA can give emergency use authorization or approval. No. Individuals 6 months through 4 years of age: vials with maroon caps and labels with maroon borders, a single dose is 0.2 mL. All of these criteria must be met to allow for the product to be used under EUA during the COVID-19 pandemic. n=264, 30 mcg/Dose Immunogenicity analyses have been performed in the immunobridging subset of 82 Study 3 participants 6 through 23 months of age without evidence of infection up to 1 month after Dose 3 based on a data cutoff date of April 29, 2022. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose and single dose vials with gray caps and labels with gray borders also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. Throughout the safety follow-up period to date, Bells palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. This website is using a security service to protect itself from online attacks. COVID Data Tracker. Surveillance Time (n2#), Placebo Further additional dose(s) may be administered, informed by the clinical judgment of a healthcare provider and personal preference and circumstances. Their median age was 67 years (range 56 through 85 years of age), 53.1% were male and 46.9% were female, 89.8% were White, 14.8% were Hispanic/Latino, 5.2% were Asian, and 4.3% were Black or African American. Multiple Dose Vials with Orange Caps and Labels with Orange Borders. The efficacy information in participants 12 through 15 years of age is presented in Table 25. As the Department of Health started inoculating health care workers and the immunocompromised population with bivalent vaccines against COVID-19 yesterday, President Marcos appealed to Filipinos . Your IP: 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 and older. ANALYSIS(59267-0609, 59267-0565, 59267-1404, 59267-0304), MANUFACTURE(59267-0609, 59267-0565, 59267-1404, 59267-0304), PACK(59267-0609, 59267-0565, 59267-1404, 59267-0304), LABEL(59267-0609, 59267-0565, 59267-1404, 59267-0304), Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, ANALYSIS(59267-0609, 59267-0565, 59267-1404, 59267-0304), API MANUFACTURE(59267-0609, 59267-0565, 59267-1404, 59267-0304), ANALYSIS(59267-0609, 59267-0565, 59267-1404, 59267-0304), BioNTech Innovative Manufacturing Services GmbH, ANALYSIS(59267-0565, 59267-1404, 59267-0304), MANUFACTURE(59267-0565, 59267-1404, 59267-0304), PACK(59267-0565, 59267-1404, 59267-0304), LABEL(59267-0565, 59267-1404, 59267-0304), ANALYSIS(59267-1404, 59267-0304), MANUFACTURE(59267-1404, 59267-0304), PACK(59267-1404, 59267-0304), LABEL(59267-1404, 59267-0304).
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