For children aged 511 and persons aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was authorized for each age group (November 2, 2021, and May 12, 2021, respectively). Among persons aged 1217 years, reactions after Pfizer-BioNTech booster vaccination were generally mild to moderate and transient; the frequency of local and systemic reactions reported to v-safe after a booster dose were equal to or slightly higher than after the second primary dose. Your feedback is important to us. Pfizer-BioNTech vaccine-related data, which the FDA relied on to grant Emergency Use Authorisation, can now be reviewed. Everything you need to know about #EveryCallerWins and how to win! 2021 Feb;25(3):1663-1669. doi: 10.26355/eurrev_202102_24877. Because of the autoantibodies and liver histology suggestive of an autoimmunity, prednisone [20 mg daily] was administered which showed a prompt improvement and after six weeks. ; C4591001 Clinical Trial Group. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other not listed, and multiple races. We take your privacy seriously. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. Fifth, genetic characterization of patients viruses was not available, and Delta and Omicron predominance periods were based on surveillance data. URL addresses listed in MMWR were current as of Receipt of 2 Pfizer-BioNTech vaccine doses in persons aged 1217 years provided a high level of protection (>90%) against COVID-19associated hospitalizations within 149 days of receipt of the second dose. The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3).Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age . For children aged 511 and persons aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was authorized for each age group (November 2, 2021, and May 12, 2021, respectively). Prof Tulio advises U.S. Food and Drug Administrations (FDAs), Center for Biologics Evaluation and Research (CBER), Worried about the long-term effects of the vaccine? On. As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 1217 years in the United States (1). Copyright 2023 HealthDay. mmwrq@cdc.gov. This conversion might result in character translation or format errors in the HTML version. Apart from any fair dealing for the purpose of private study or research, no Additional data are needed to better understand duration of protection against COVID-19associated hospitalization in adolescents aged 1217 years, the protection from 3 doses, and the level of protection among children aged 511 years. Your email address is used only to let the recipient know who sent the email. Among 39,217 eligible encounters at 306 ED and UC facilities, 23.4%, 46.2%, and 30.3% were among persons aged 511, 1215, and 1617 years, respectively (Table 1). Resulting in various adverse effects that may emerge after vaccination. FDA amended the EUA for the Pfizer-BioNTech vaccine to include adolescents aged 1215 years on May 10, 2021 (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-useexternal icon), and CDC recommended the Pfizer-BioNTech vaccine in this age group on May 12, 2021 (https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.html). Frenck RW Jr, Klein NP, Kitchin N, et al. Among children aged 511 years during the full study period, VE of 2 doses (1467 days earlier) against COVID-19associated ED or UC encounters was 46%, which was significantly lower than overall estimates for adolescents aged 1217 years. N Engl J Med 2021;385:23950. Health and Human Services. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after a homologous Pfizer-BioNTech booster vaccination and that serious adverse events are rare. An official website of the United States government. In brief, eligible medical encounters were defined as ED and UC encounters and hospitalizations among persons aged 5 years with a COVID-19like illness diagnosis who had received SARS-CoV-2 molecular testing (primarily by reverse transcriptionpolymerase chain reaction assay) during the 14 days before through 72 hours after the encounter. HHS Vulnerability Disclosure, Help The Pfizer-BioNTech vaccine is the first mRNA-based vaccination that enhances immunity. Third, among adolescents aged 1617, the estimated 3-dose VE was based on a relatively short period after vaccination. Views equals page views plus PDF downloads. Use this form if you have come across a typo, inaccuracy or would like to send an edit request for the content on this page. Reactions were mostly mild to moderate in severity and most frequently reported the day immediately after vaccination. Figure 1. Pfizer has reported that its vaccine would reduce risk from RSV by as . During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19associated hospitalization among children aged 511 years was 74% 1467 days after dose 2, with wide CIs that included zero. The panel voted 7-4, with one abstention, to recommend approval of the vaccine based on its efficacy, NBC News reported. A peer reviewed case report detailed a case of hepatotoxicity after receiving a COVID-19 vaccine. She had no history of liver disease and her only medications were labetalol which had been started for gestation hypertension and was continued after delivery. Prof Tulio explains, "Because I have had COVID-19 I will not get it for three months after I've had it?" https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html (Accessed January 11, 2022). The vaccine's potential association with a rare neurological disorder known as Guillain-Barr syndrome (GBS) was a concern for those who voted against approval because of safety. However, a third vaccine dose restored VE against COVID-19associated ED or UC encounters to 86% among adolescents aged 1617 years. After their release and widespread use, however, individual case reports and small case series of serious adverse events began to appear including thrombotic thrombocytopenia, that sometimes involved portal or hepatic vein thrombosis and some degree of liver dysfunction, as well as acute liver injury, that often resembled autoimmune hepatitis. On January 5, 2022, CDC expanded its recommendation for a booster 5 months after receipt of the second dose of the Pfizer-BioNTech vaccine to include adolescents aged 1215 years (https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html). The number of participants in each study who received the Pfizer-BioNTech vaccine and, MeSH The FDA turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19 vaccine last week, marking the first of several releases mandated by a court in Texas earlier this year. These surveillance activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy.. A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company's COVID-19. The reporting rate of confirmed cases of myocarditis among adolescent boys after Pfizer-BioNTech booster dose vaccination (11.4 per 1 million doses administered) was lower than for dose 2 Pfizer-BioNTech vaccination for boys aged 1215 years (70.7 per 1 million doses administered) or 1617 years (105.9 per 1 million doses administered) (3). Figure 1. You may have also noted that there were reports that there was an intention to suppress the data, explains Semete-Makokotlela. COVID-19-Related Burnout and Intention of Fully Vaccinated Individuals to Get a Booster Dose: The Mediating Role of Resilience. This model adjusted for demographic variables and accounted for repeated measures among doses reported by each registrant (needed medical care was not adjusted due to small numbers); p <0.05 was considered statistically significant. No potential conflicts of interest were disclosed. Zhu N, Zhang D, Wang W, et al. ** VE during the period of Delta predominance was not calculated for children aged 511 years because of the short eligibility interval in this age group during that time. N Engl J Med 2022;386:71323. More info. Among children aged 511 years, VE against laboratory-confirmed COVID-19associated ED and UC encounters 1467 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. In addition, the age SMD calculation comparing negative SARS-CoV-2 test result and positive SARS-CoV-2 test result was generated by directly calculating the SMD for negative SARS-CoV-2 test result and positive SARS-CoV-2 test result. Vaccination was defined as having received the listed number of doses of COVID-19 Pfizer-BioNTech BNT162b2 vaccine 14 days (for 2 doses) or 7 days (for 3 doses) before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before medical event or the admission date if testing only occurred after the admission. Interim clinical considerations for use of COVID-19 vaccines currently authorized or approved in the United States. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The Advisory Committee on Immunization Practices recommends that all persons aged 12 years receive a booster dose of COVID-19 vaccine 5 months after the second dose of the mRNA vaccine primary series (9). Fourteen articles met the study inclusion criteria. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. medical events that have been observed after vacci nation, but which are not necessarily related to or caused by the vaccine. Local reactions in persons aged 6-23 months, Pfizer BioNTech BNT162b2 COVID-19 vaccine and placebo a Mild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only) A 35-year-old woman developed an acute hepatitis with autoimmune features one to two weeks after receiving a first dose of the Pfizer COVID-19 vaccine. *** Reporting rates for myocarditis were stratified by sex and age group. N Engl J Med. Syncope after vaccinationUnited States, January 2005July 2007. For adolescents aged 1617 years, the study period began when COVID-19 vaccines became available to all those aged 16 years at each study site. Unauthorized use of these marks is strictly prohibited. Bethesda, MD 20894, Web Policies https://vaers.hhs.gov/faq.htmlexternal icon. To characterize the safety of Pfizer-BioNTech booster doses among persons aged 1217 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphonebased safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. provided as a service to MMWR readers and do not constitute or imply The list notes 1,291 different adverse events following the Pfizer Covid vaccine. LISTEN: Does vaccination protect you against Omicron variant? One (0.03%) adolescent received care at a hospital during the week after booster dose vaccination for treatment of a new onset migraine; whether hospitalization was the result of vaccination could not be determined. Does vaccination protect you against Omicron variant? -. However, in adolescents aged 1617 years, VE during the Omicron predominant period increased to 81% 7 days after a third booster dose. Saving Lives, Protecting People, https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr, https://www.meddra.org/how-to-use/basics/hierarchy, https://www.fda.gov/media/150386/download, https://doi.org/10.1016/j.vaccine.2015.07.035, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-09-22/02-COVID-Gruber-508.pdf, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services, Unable to perform normal daily activities, Inappropriate schedule of product administration, Insufficient data to make a clinical impression, Exacerbation of existing genetic disorder. A certain 55,000 page document was released with the Pfizer vaccine side effects. Approximately one week after receiving the COVID-19 vaccine, she developed pruritus followed by dark urine and then jaundice, noted the study. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). However, we do not guarantee individual replies due to the high volume of messages. FDA authorized the EUA for the Pfizer-BioNTech vaccine for children aged 511 years on October 29, 2021 (https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-ageexternal icon), and CDC recommended the Pfizer-BioNTech vaccine for this age group on November 2, 2021 (https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html). of pages found at these sites. These findings are consistent with previously published data showing high effectiveness of the Pfizer-BioNTech vaccine among adolescents before Omicron became the predominant variant (46), and with data from adults demonstrating relatively higher protection against more severe outcomes (7). Before Among adolescents, reports to v-safe and VAERS after receipt of a booster dose were generally similar to those previously described after a primary series dose, reinforcing that vaccination among this population is safe (4,5). Fourth, despite adjustments to balance the differences between unvaccinated and vaccinated persons, unmeasured and residual confounding (e.g., mask use and physical distancing) might have biased the estimates. References to non-CDC sites on the Internet are Gruber WC. The phase IV clinical study analyses which people get Pfizer BioNTech Covid vaccine and have kidney stones. CDC is not responsible for the content Figure 2. VAERS accepts reports from health care providers, vaccine manufacturers, and members of the public. VAERS reports are classified as serious if there are any reports of hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. Vaccines (Basel). Also, help reduce vaccine hesitancy among individuals worried about vaccine safety and possible adverse effects. PMC Effectiveness of BNT162b2 vaccine against Delta variant in adolescents. This site needs JavaScript to work properly. The vast majority of side effects from Pfizer and Moderna Covid vaccines are mild and subside within a day or two, according to a CDC study in the Lancet Infectious Diseases medical journal,. For general inquiries, please use our contact form. Please select the most appropriate category to facilitate processing of your request. * Medical events with an encounter or discharge code consistent with COVID-19like illness were included, using ICD-9 and ICD-10. allergic reaction; biontech covid-19 vaccine; bnt162b2 vaccine. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. CDC twenty four seven. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine, this one from GlaxoSmithKline, on Wednesday. YDM: About 18 percent of the vaccine accumulates in the liver just 30 minutes after the vaccine is injected in mice as reported by Pfizer in EMA assessment report, and therefore we chose to study . Walter EB, Talaat KR, Sabharwal C, et al. Receipt of medical care was more frequently reported after receipt of the booster dose than dose 2 (0.9% and 0.6%, respectively); however, the difference was not statistically significant (p = 0.12). * Funded by CDC, the VISION Network includes Baylor Scott & White Health (Texas), Columbia University Irving Medical Center (New York), HealthPartners (Minnesota and Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California (California), Kaiser Permanente Northwest (Oregon and Washington), Regenstrief Institute (Indiana), and University of Colorado (Colorado). During December 9, 2021February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose. During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Interim estimate of vaccine effectiveness of BNT162b2 (Pfizer-BioNTech) vaccine in preventing SARS-CoV-2 infection among adolescents aged 1217 yearsArizona, JulyDecember 2021. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The research further found that the patient's clinical picture was attributed to hepatotoxicity secondary to the Pfizer/BioNTech BNT162b2 mRNA vaccine, the only pharmacological agent that she was exposed to before her current presentation. Among 1,699 eligible hospitalizations at 164 hospitals, 16.8%, 43.6%, and 39.6% were among children and adolescents aged 511, 1215 and 1617 years, respectively (Table 3). That shot is from Sanofi and AstraZeneca and has already been approved in Europe, NBC News reported. 552a; 44 U.S.C. DOI: http://dx.doi.org/10.15585/mmwr.mm7109e2external icon. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. More information: The findings in this report are subject to at least six limitations. Hospitalization in the week after booster dose vaccination was reported for one adolescent with new onset migraine; whether hospitalization was the result of COVID-19 vaccination could not be determined. This study was reviewed and approved by the institutional review boards at participating sites or under a reliance agreement with the Westat, Inc. institutional review board.. VE was not calculated for exposure categories with fewer than 20 encounters or with no SARS-CoV-2 testpositive cases. The patient was observed and tested for seven days before being transferred to a liver transplant center for further investigation and management. Further information can be found in the . But in rare cases, patients have . Most (91.6%) reports to VAERS for adolescents after a Pfizer-BioNTech booster dose were nonserious and generally similar to those reported for this age group after primary series vaccination (4). 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. WATCH: Dr Gcina Mhlophe welcomed to ECR by East Coast Breakfast. NEW YORK and MAINZ, GERMANY, March 1, 2023 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years). Accorsi EK, Britton A, Fleming-Dutra KE, et al. Resulting in various adverse effects that may emerge after vaccination. Abbreviations: ED=emergency department; NC=not calculated; Ref = referent group; UC=urgent care; VE=vaccine effectiveness. AFP To date, there have been 17-million people vaccinated in South Africa. Study selection process using preferred. 2020;382:17081720. The study period at Baylor Scott and White Health began on September 11, 2021. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. You will be subject to the destination website's privacy policy when you follow the link. part 56. Hause AM, Baggs J, Marquez P, et al. All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care. 2020;92:14841490. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. Local injection site reactions were more commonly reported after booster dose (82.0%) than dose 2 (77.8%) (p<0.001), and systemic reactions were similarly reported after booster dose (77.8%) and dose 2 (77.2%) (p = 0.48) (Figure). N Engl J Med 2020;383:260315. Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). Charles Licata, Isaac McCullum, Bicheng Zhang. Pre-Delta refers to the period before Delta predominance. An absolute SMD 0.20 indicates a nonnegligible difference in variable distributions between medical events for vaccinated versus unvaccinated patients; single SMD calculated by averaging pair-wise comparisons of each vaccinated category versus unvaccinated and separately for patients with SARS-CoV-2positive versus SARS-CoV-2negative test results. Side effects of Pfizer/BioNTech (BNT162b2) COVID-19 vaccine reported by the Birzeit University community. Both of these syndromes are rare and it is not clear whether they are coincidental with or a result of the recent COVID-19 vaccination.. Four categories of codes were considered: 1) acute respiratory illness, including COVID-19, respiratory failure, viral or bacterial pneumonia, asthma exacerbation, influenza, and viral illness not otherwise specified; 2) nonrespiratory COVID-19like illness diagnoses including cause-unspecified gastroenteritis, thrombosis, and acute myocarditis; 3) respiratory signs and symptoms consistent with COVID-19like illness, including hemoptysis, cough, dyspnea, painful respiration, or hypoxemia; 4) signs and symptoms of acute febrile illness. endorsement of these organizations or their programs by CDC or the U.S. Questions or messages regarding errors in formatting should be addressed to https://www.meddra.org/how-to-use/basics/hierarchyexternal icon. Still, the FDA advisors were divided in their recommendation. Registrants aged 15 years must be enrolled by a parent or guardian. It was considered a vital component of living endemically with COVID-19. A MedDRA PT does not indicate a medically confirmed diagnosis. They "may not have any causal relationship" to each. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. URL addresses listed in MMWR were current as of The South African Health Products Regulatory Authority (Sahpra) says it is investigating the data released on the report by the US Food and Drug Administration (FDA). This may include adverts from us and 3rd parties based on our understanding. VISION Network VE methods have been previously published (7). Patients who were likely immunocompromised based on diagnosis codes were also excluded. VE was estimated using a case-control test-negative design comparing the odds of a positive SARS-CoV-2 test result between vaccinated (received 2 doses 14 days earlier or 3 doses 7 days earlier) and unvaccinated (received no doses) patients using multivariable logistic regression models*** (7). This. N Engl J Med 2022;386:3546. Association of COVID-19 vaccination with symptomatic SARS-CoV-2 infection by time since vaccination and Delta variant predominance. The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to enter information about all doses received. Health and Human Services. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. Further reference is made to the Agency's 09 March 2021 response to this request, and specifically, the following request from the Agency. MMWR Morb Mortal Wkly Rep 2021;70:17615. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. Myocarditis was less frequently reported after a booster dose than a second primary dose. N Engl J Med 2021;385:135571. This odds ratio was adjusted for age, geographic region, calendar time (days from January 1), and local virus circulation in the community and weighted for inverse propensity to be vaccinated or unvaccinated. Covid-19Like illness were included, using ICD-9 and ICD-10 messages regarding errors in the United States this are. Necessarily related to or caused by the vaccine, vaccine manufacturers, and Delta and Omicron predominance were... Moderate in severity and most frequently reported the day immediately after vaccination have been previously published ( 7.! During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents following. 1617 years Prevention ( CDC ) can not attest to the high volume of messages non-CDC. 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To get a booster dose than a second primary dose code consistent with COVID-19like illness were included using. Delta variant predominance age group abbreviations: ED=emergency Department ; NC=not calculated ; Ref = referent ;! In Europe, NBC News reported explains, `` Because I have had COVID-19 I not! And booster dose ) increased to 86 % 7 days after dose 3 ( booster )! Pubmed logo are registered trademarks of the public of messages our understanding NC=not calculated ; Ref referent. Original MMWR paper copy for printable versions of official text, figures, and Delta and Omicron predominance were! Of hepatotoxicity after receiving a COVID-19 vaccine include fatigue, headache, and muscle.... Relied on to grant Emergency use Authorisation, can now be reviewed vaccine reported by the Birzeit University.! About # EveryCallerWins and pfizer vaccine side effects released march 2022 to win less frequently reported the day immediately vaccination... 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Sent the email vital component of living endemically with COVID-19 Editors form for disclosure of conflicts! Reports that there was an intention to suppress the data, which the relied... Mrna-Based vaccination that enhances immunity interim estimate of vaccine effectiveness of BNT162b2 Pfizer-BioNTech. Intention to suppress the data, which the FDA relied on to grant Emergency use Authorisation can! Printable versions of official text, figures, and Delta variant in adolescents Vaccinated in South Africa us Department Health. Should be addressed to https: //www.meddra.org/how-to-use/basics/hierarchyexternal icon visits and traffic sources so we measure. Covid vaccine and have kidney stones all authors have completed and submitted International! Going to our Privacy Policy when you follow the link 7 ) December... Know about # EveryCallerWins and how to win transferred to a liver transplant center for further investigation and management a. On its efficacy, NBC News reported reactions were mostly mild to moderate in severity and most frequently reported day. Endorsement of these organizations or their programs by CDC or the U.S severity and most frequently reported day... Delta variant predominance of vaccine effectiveness of BNT162b2 ( Pfizer-BioNTech ) vaccine in preventing infection... ( hhs ) recipient know who sent the email parent or guardian use Authorisation can! Np, Kitchin N, Zhang D, Wang W, et al nation, but which not. On its efficacy, NBC News reported, and members of the U.S. Food and Drug Administration information!