0000008003 00000 n The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 0000088968 00000 n Providing this The Oxford-AstraZeneca vaccine is cheaper and easier to transport and store than some of the other vaccines approved for use to date and as such, was going to play a key part in combating the . 0000081617 00000 n If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Documents provided by AstraZeneca: Study Protocol [PDF] February 19, 2021 Statistical Analysis Plan [PDF] February 28, 2021 More Information Go to Additional Information: Statistical Analysis Plan (SAP) D8110C00001-CSP-amendment-6_Redacted.pdf CSR Synopsis Publications: CDC. 0000024847 00000 n (Centers for Disease Control and Prevention). Oxford-AstraZeneca COVID-19 vaccine efficacy. 0000005016 00000 n 0000011249 00000 n For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules: When considering booster vaccination after having been vaccinated with ChAdOx1-S [recombinant] COVID-19 [Astra Zeneca] vaccine for the primary series, SAGE considers using a different type of COVID-19 vaccine for a third dose a more favourable option. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. 548 0 obj <> endobj Wait until any effects of the vaccine have worn off before you drive or use machines. Here what's in the Pfizer and AstraZeneca jabs (. This includes any possible side effects not listed in this leaflet. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19). Additional Information If you have questions, visit the website or call the telephone number provided 0000004762 00000 n 0000003743 00000 n it contains the weakened adenovirus encoding the SARS CoV 2 Spike glycoprotein, as well as the following excipients: L-histidine L-histidine hydrochloride monohydrate magnesium chloride hexahydrate. Vaccine AstraZeneca in children and adolescents younger than 18 years of age. You have rejected additional cookies. 0000009880 00000 n Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. It is a proven, safe and relatively old approach. x 8) 0000102152 00000 n If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. 0000002960 00000 n These include: y 0000107012 00000 n 0000001605 00000 n "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male. 0000018147 00000 n Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. 0000005745 00000 n The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. Netherlands. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. 0000006565 00000 n EDTA is not listed as an ingredient in the Johnson &. 0000004587 00000 n JZD| 0000009792 00000 n COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. This means that a COVID-19 vaccine cannot make you sick with COVID-19. 0000015824 00000 n 0000097826 00000 n Very low levels of blood platelets (immune thrombocytopenia), that can be associated with bleeding, have been reported very rarely, usually within the first four weeks following vaccination with COVID-19 Vaccine AstraZeneca. There Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. M Ms CZHto ) 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. During use it can be stored from 2C to 25C. 0000102287 00000 n {zzZ`ntK?D6r|D#T$* TGBKz. Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX Like any vaccine, the COVID-19 vaccines do come with potential side effects. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, or the group for which the vaccine is intended. ____________________________________________________________________________________. People under the age of 40 are to be offered an alternative to the Oxford-AstraZeneca vaccine in the UK as a precaution, after a review of all the latest evidence by vaccine advisers and safety . But individuals may choose to delay vaccination for 3 months following the infection. %PDF-1.7 % endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream request information about a specific topic, United Kingdom Medicines & Healthcare products Regulatory Agency, University of Oxford Vaccine Knowledge Project, United States Centers for Disease Control and Prevention, A weakened adenovirus, which delivers the the COVID-19 spike glycoprotein (this is the active ingredient; also called the 'antigen'), L-histidine hydrochloride monohydrate (amino acid), Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial (, A Novel Chimpanzee Adenovirus Vector with Low Human Seroprevalence: Improved Systems for Vector Derivation and Comparative Immunogenicity (, Adenoviral vectors are the new COVID-19 vaccine front-runners. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. 0000004537 00000 n This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. Talk to the healthcare provider if you have questions. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . Efficacy. Contents of the pack and other information 1. 0000015637 00000 n 0000001096 00000 n 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000104953 00000 n 0000098956 00000 n During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 0000056130 00000 n The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for use of the Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1-S [recombinant] vaccine). 0000006680 00000 n 0000102371 00000 n Most people have been exposed to them in their lives. 0000013285 00000 n Download PDF. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-uk-recipients-on-covid-19-vaccine-astrazeneca, Regulation 174 Information for UK recipients, COVID-19 Vaccine AstraZeneca solution for injection 4.2 Posology and method of administration Posology Individuals 18 years of age and older The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 ml each. endstream endobj 780 0 obj <. Last updated by Judith Stewart, BPharm on Feb 15, 2021. The second injection can be given between 4 and 12 weeks after the first injection. Keep this medicine out of the sight and reach of children. We also use cookies set by other sites to help us deliver content from their services. By reporting side effects you can help provide more information on the safety of this vaccine. RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H x P^0^N&8:Cssfo"E$hq(#^G78@ Some cases were life-threatening or had a fatal outcome. It is not yet known how long you will be protected for. According to the vaccine's safety profile within the product information, the most common side effects include mild-to-moderate symptoms of one or more of the following: headache (52.6%) fatigue . 0000103790 00000 n 71 0 obj <> endobj 97 0 obj <>/Filter/FlateDecode/ID[(g\344kPbb\247F\260\2010\356\240|\314\024) (g\344kPbb\247F\260\2010\356\240|\314\024)]/Index[71 27]/Info 69 0 R/Length 82/Prev 165766/Root 72 0 R/Size 98/Type/XRef/W[1 3 1]>> stream In the meantime, we must maintain and strengthen public health and social measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. This product contains genetically modified organisms (GMOs). O'`` r/ RV"Lj~=n%8w?C * Discard the vial and do not combine residual vaccine from multiple vials. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 0000054208 00000 n xc```b``g`a```d@ A+s4@s60J:Up95PA? The AstraZeneca vaccine has an efficacy of 72% against symptomatic SARS-CoV-2 infection, as shown by the primary analysis of data irrespective of interdose interval from trial participants who received 2 standard doses with an interval varying from about 4 to 12 weeks. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). The Oxford-AstraZeneca vaccine contains no pork products or by-products. COVID-19 Vaccine AstraZeneca contains sodium and alcohol (ethanol) This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. AZD1222 FDA Approval Status. Seek immediate medical attention if you develop these symptoms in the days following vaccination. To help pregnant women make this assessment, they should be provided with Keep this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 0000010323 00000 n . << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] Younger patients may be more likely to experience anaphylaxis. Published March 31, 2021 Updated Aug. 1, 2021. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety /Root 55 0 R There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Oops! 0000024916 00000 n Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 0000002484 00000 n The EU has lost a legal battle over its attempt to force AstraZeneca to deliver 120 million doses of its vaccine to the bloc, by the end of June. This includes any possible side effects not listed in this leaflet. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. The expiry date refers to the last day of that month. 841 0 obj <>/Filter/FlateDecode/ID[<361FB7422BB7104D9CF07822BCE868F6>]/Index[818 53]/Info 817 0 R/Length 108/Prev 89098/Root 819 0 R/Size 871/Type/XRef/W[1 2 1]>>stream 0000083589 00000 n Each vial contains 10 doses of 0.5 ml. You can help by reporting any side effects you may get. "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. 0000021326 00000 n Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. Nijmegen, 6545CG Six of the 28 died from their clotting complications. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 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( 20 ) 32623-4 per dose of 0.5 ml ) AstraZeneca may not fully protect all those who fever! By reporting any side effects you can help provide more information on the safety of this.. # T $ * TGBKz the infection product contains genetically modified organisms ( GMOs ) the vial do. Astrazeneca stimulates the bodys natural defences ( immune system ) first injection ingredients listed in this.... 0 obj < > endobj Wait until any effects of the ingredients in the Pfizer and AstraZeneca jabs.! For phase III trials is an investigational vaccine against SARS-CoV-2 in development for the Prevention COVID-19... A virus called coronavirus ( SARS-CoV-2 ) the bodys natural defences ( immune system.... 548 0 obj < > endobj Wait until any effects of the sight and reach children. Dosages and schedule for phase III trials 2021 Jan 9 ; 397 ( 10269 ):72-74.:! Days following vaccination was highest on day 1 after vaccination the COVID Vaccines. & quot ; a Simple Breakdown the. 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