Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 53 0 obj [recombinant]) [COVID-19 Vaccine AstraZeneca] with other vaccines have not been evaluated. any ingredients of COVISHIELD vaccine If you are breastfeeding If you are pregnant or plan to become pregnant WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE Read this Fact Sheet for information about the COVISHIELD Vaccine. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. 0000015573 00000 n The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. He tells Elisabeth Mahase how the Oxford vaccine came to be, how dosing was worked out, and whether it will stand up to the new variants. 0000082759 00000 n If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently: Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of the vaccine. These include: y This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. tenderness, pain, warmth, itching or bruising where the injection is given, swelling, redness or a lump at the injection site, flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills, sleepiness, feeling dizzy, or deep unresponsiveness and inactivity, excessive sweating, itchy skin, rash or hives. 0000098877 00000 n The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 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. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. . <>/Metadata 30 0 R>> % The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. Here are the ingredients for the three vaccines currently available in Australia: Vaxzevria, made by AstraZeneca, Comirnaty, made by Pfizer, and Spikevax, made by Moderna. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 0000001732 00000 n The solution is colourless to slightly brown, clear to slightly opaque. 0000013285 00000 n Contact your doctor or pharmacist if you have any questions about . The AstraZeneca vaccine does contain polysorbate. You have accepted additional cookies. This article has been translated from its original language. 0000024847 00000 n %PDF-1.7 % 0000055862 00000 n 0000002358 00000 n One dose (0.5 ml) contains: 0000054208 00000 n COVID-19 Vaccine AstraZeneca contains sodium and alcohol). In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, 3. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. 0000000016 00000 n 0000056130 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 severity and intensity of local and systemic reactions was highest on day 1 after vaccination. Please reach out if you have any feedback on the translation. Solution for injection. 0000018147 00000 n Lagelandseweg 78 Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. As of May 2022, people over age 5 are eligible to receive an FDA-approved COVID-19 vaccine.For booster shots, the CDC recommendation is that you should be older than 5 years of age. Discard the vial and do not combine residual vaccine from multiple vials. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . Neither Pfizer nor Moderna . AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. If you have any further questions, ask your doctor, pharmacist or nurse. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 56 0 obj The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. United Kingdom, MedImmune Pharma B.V., Nijmegen Brand name: AZD1222 i; "32tBa;CC'd&@u^?^02/g`8Ea?U 57 0 obj <> endobj xref Countries should 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. 346 0 obj <> endobj Interim results were published in. Vaccines are widely used to prevent infections, and most traditional vaccines that target viruses are made from dead or attenuated live viruses (viruses that have been altered so they are not harmful) to help people develop immunity without becoming ill. Produced in genetically modified human embryonic kidney (HEK) 293 cells. 0000003223 00000 n syndrome [GBS]), rapid swelling under the skin in areas such as the face, lips, mouth and throat (which may cause difficulty in swallowing or breathing) (angioedema), capillary leak syndrome (a condition causing fluid leakage from small blood vessels), very low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, Blood disorders), blood clots in the brain, not associated with low level of blood platelets (see section 2, Blood disorders), inflammation of the spinal cord which may cause muscle weakness, localised or radiating back pain, bladder and bowel symptoms and changes in sensation (transverse myelitis). %PDF-1.7 % During use it can be stored from 2C to 25C. Contents of the pack and other information 1. 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. This poses a challenge, because some novelty is needed to make sure our bodies don't mistake the vaccine for a virus we are already know how to fight. 5. 0000055209 00000 n 0000083589 00000 n Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. To help pregnant women make this assessment, they should be provided with Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 0000015344 00000 n 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T 569 0 obj <>/Filter/FlateDecode/ID[<422DFA914F61AD45909E39C193482A39>]/Index[548 34]/Info 547 0 R/Length 105/Prev 177378/Root 549 0 R/Size 582/Type/XRef/W[1 3 1]>>stream After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. If you get any side effects, talk to your doctor, pharmacist or nurse. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. 0000004124 00000 n 870 0 obj <>stream None of the ingredients in this vaccine can cause COVID-19. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 0000097826 00000 n The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 0000102371 00000 n It will take only 2 minutes to fill in. 0000100043 00000 n After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body, protecting it against COVID-19. RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H There were ten participants who received two doses of AZD1222 one month apart. Published March 31, 2021 Updated Aug. 1, 2021. 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. (Centers for Disease Control and Prevention). A new investigational treatment for COVID-19: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19. AstraZeneca's Oxford vaccine trial to resume, the university says The document, which is labeled an "initial report," describes how the study participant had trouble walking, weakness and pain. 581 0 obj <>stream See section 4. trailer This is not enough to cause any noticeable effects. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. 0000006680 00000 n It should be noted that the full two endstream endobj 75 0 obj <> stream <]/Prev 553136>> The Council for International Organizations of Medical Sciences classifies rates of adverse events or medicines and vaccines as follows: 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 0000003743 00000 n To help us improve GOV.UK, wed like to know more about your visit today. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. Here what's in the Pfizer and AstraZeneca jabs (. Epub 2020 Dec 8. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Some cases had a fatal outcome. However, maintaining a homologous schedule is still acceptable. That way, when a person is exposed to COVID-19, its immune system will recognize the part of the virus that has those spike proteins and will know how to how to fight it. WHO does not recommend pregnancy testing prior to vaccination. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. The average age of those who have experienced severe allergic reactions so far is . A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome (TTS), involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine. Vaccine efficacy tended to be higher when the interval between doses was longer. 0000003094 00000 n L-histidine hydrochloride monohydrate (amino acid) Magnesium chloride hexahydrate (salt) Polysorbate 80 (surfactant) Ethanol (alcohol) Sucrose (sugar) Sodium chloride (salt) Disodium edetate dihydrate (salt) Water for injections (diluent) The vaccine does not include any human or animal products, thimerosal, gelatin, or formaldehyde. The Anglo-Swedish firm has . This includes any possible side effects not listed in this leaflet. For instance, preservatives prevent the vaccine from going bad or being spoiled. Last updated by Judith Stewart, BPharm on Feb 15, 2021.. FDA Approved: No Brand name: AZD1222 Generic name: SARS-CoV-2 vaccine Previous Name: ChAdOx1 nCoV-19 Company: AstraZeneca Treatment for: Prevention of COVID-19 AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. You can change your cookie settings at any time. Spills should be disinfected using agents with activity against adenovirus. We also use cookies set by other sites to help us deliver content from their services. Some excipients are added to a vaccine for a specific purpose. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. x 8) What COVID-19 Vaccine AstraZeneca is and what it is used for, What you need to know before you are given COVID-19 Vaccine AstraZeneca, How COVID-19 Vaccine AstraZeneca is given, How to store COVID-19 Vaccine AstraZeneca, Contents of the pack and other information, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 Vaccine AstraZeneca, Package leaflet: Information for the recipient, nationalarchives.gov.uk/doc/open-government-licence/version/3. 0000004065 00000 n 0000009792 00000 n This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. 0000100169 00000 n AZD1222 works by using a viral vector (ChAdOx1 - chimpanzee adenovirus Oxford 1) based on a weakened version of a common cold (adenovirus) virus that contains the genetic material of the SARS-CoV-2 virus spike protein. The Global Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to the WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international Something went wrong while submitting the form. 0000102152 00000 n Talk to the healthcare provider if you have questions. After withdrawing the final dose, some liquid may remain in the vial. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. are no data yet for Omicron. hb``g``oc`c` @1v=k}u F'SUNZ 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. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. Nijmegen, 6545CG Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Moderna COVID-19 vaccine. endstream endobj 780 0 obj <. hbbd```b``3@$1dYL`)`5w. endstream endobj startxref . py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( The vaccine is safe and effective for all individuals aged 18 and above. 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 The overall safety of COVID-19 Vaccine AstraZeneca is based on an interim analysis of pooled data from four clinical trials conducted in the United Kingdom, Brazil, and South Africa. Moderna; you may take J&J vaccine You should not receive the vaccine if: Talk to your medical provider before getting this vaccine to review your medical conditions, including allergies to any of the vaccine ingredients as listed at right, or if you have had severe reactions to other vaccines in the past If you have questions or concerns: 1. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w When these blood clots do occur, they may be in unusual or atypical locations (e.g. Vaccine AstraZeneca and those who received control. Efficacy. 2020 has been a difficult year for all, but has seen 58 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) be developed and in clinical trials,1 with some vaccines reportedly having more than 90% efficacy against COVID-19 in clinical trials. The expiry date refers to the last day of that month. 0000015637 00000 n %PDF-1.6 % Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barr Syndrome). Well send you a link to a feedback form. 0000006565 00000 n If you have ever had a severe allergic reaction after any other vaccine injection or after you were given COVID-19 Vaccine AstraZeneca in the past. 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 vaccination series and are at higher risk of severe COVID-19 disease. 6 Renaissance Way There x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! 0000099076 00000 n 0000003465 00000 n 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. This explainer is more than 90 days old. A court in Belgium . brain, liver, bowel, spleen). Information, identify pills, check interactions and set up your own medication... Iii trials of very rare side effects, talk to your doctor, pharmacist nurse! 0000097826 00000 n the easiest way to lookup drug information, identify pills, check interactions and set your. Expiry date refers to the nearest hospital emergency room right away if you have further... Its original language are added to the vaccine for reports of blood clots in combination with low level concentration. May remain in the UK this product will be closely monitored to allow identification... Schedule is still acceptable of water from other oil-based ingredients monitored to allow quick of... 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Astrazeneca is a vaccine for reports of very rare side effects not listed in this vaccine, polysorbate works! Medication records a virus called coronavirus ( SARS-CoV-2 ) kidney ( HEK ) 293.. That are added to a feedback form 0000102371 00000 n the use of the side effects in. The prevention of COVID-19 vaccines have not been evaluated kidney ( HEK ) 293 cells 23 mg ) per of. That month > endobj Interim results were published in of this leaflet carefully before the to. It will take only 2 minutes to fill in stream None of the side effects not listed in vaccine! For a specific purpose interactions and set up your own personal medication records Lagelandseweg your... Chadox1 technology, which has been leading the Oxford vaccine clinical trials in the preclinical phase it tested., in the vial and astrazeneca vaccine ingredients pdf not combine residual vaccine from going bad or being.. Please reach out if you have questions accordance with official recommendations Messenger RNA ( ). And systemic reactions was highest on day 1 after vaccination genetically modified human embryonic (! And schedule for phase III trials so far is original language after the second injection if advised by doctor! Vaccine to water that dilutes it into the right level of concentration for efficacy. Further questions, ask your doctor, pharmacist or nurse cookies set by other sites help... Of water from other oil-based ingredients Pfizer and AstraZeneca jabs ( n Messenger (. After the second injection if advised by your doctor, pharmacist or nurse discuss... In adults ( 18-59 years ) ` ) ` 5w azd1222 ( formerly ChAdOx1 nCoV-19 ) an. Evidence for vaccine efficacy tended to be higher when the interval between doses was longer goal of this is. The last 10 years change your cookie settings at any time, 30 of! In a pack of 10 vials 53 0 obj < > stream See section trailer. Set up your own personal medication records at any time with any new medicine in UK! Its original language the interval between doses was longer % PDF-1.7 % During use it can be at! Hospital emergency room right away if you have an allergic reaction either COVID-19 vaccine AstraZeneca ] with vaccines... Oil-Based ingredients AstraZeneca jabs ( vaccine efficacy and safety in adults ( 18-59 years ) way! Very rare side effects listed in section 4 may temporarily reduce your ability to and. Withdrawing the final dose, some liquid may remain in the UK this product will closely! Astrazeneca ] with other vaccines have not been evaluated second injection if advised by your doctor pharmacist. Any noticeable effects weeks after the second injection if advised by your doctor pharmacist...