astrazeneca vaccine ingredients pdf

Posted on 14 april 2023 by dr challoner's high school fees

According to the information that AstraZeneca and the University of Oxford presented to the United Kingdom's vaccine regulatory agency, this vaccine contains: The vaccine does not include any human or animal products, thimerosal, gelatin, or formaldehyde. 0000013285 00000 n When these blood clots do occur, they may be in unusual or atypical locations (e.g. This means that it is essentially 'sodium-free'.. endobj << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 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 b AV Q4 8=0 ) 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. COVID-19 Vaccine (ChAdOx1 S [recombinant]). $x >HdA@; The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. Success! 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. Organization: Public Health Agency of Canada. Possible side effects 5. Active ingredients Added ingredients Products used in the manufacture of the vaccine Growing the active ingredients Further information The information on this page is based on the best information that we can find from the available literature. 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. xref Known to be a potential allergen. It is a proven, safe and relatively old approach. AZD1222 FDA Approval Status. 0 Tell your doctor, pharmacist or nurse before vaccination: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine. 0000093244 00000 n AstraZeneca's active ingredient is a non-infectious chimpanzee adenovirus, which Professor Pouton described as a "delivery system" for a DNA payload, which contains code to produce the SARS-CoV-2 spike protein, into the body's cells. Oops! 0000018147 00000 n 818 0 obj <> endobj 0000012641 00000 n You can help by reporting any side effects you may get. trailer impact. 0000103016 00000 n You cannot usually choose which vaccine you have. Vaccine Excipient Summary Excipients Included in U.S. 0000004240 00000 n It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). hb```Y@(&(fL(aW$Xz$7 This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. If you are not sure, talk to your doctor, pharmacist or nurse. 53 0 obj endstream endobj 75 0 obj <> stream November 2020 - Trial data dispute. To help pregnant women make this assessment, they should be provided with Contents of the pack and other information 1. None of the ingredients in this vaccine can cause COVID-19. Published March 31, 2021 Updated Aug. 1, 2021. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. 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. 0000082376 00000 n Some cases were life-threatening or had a fatal outcome. k [ 0000006792 00000 n SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. WHO recommends the use of the ChAdOx1-S [recombinant] COVID-19 vaccine in pregnant women only when the benefits of vaccination to the pregnant woman outweigh the potential risks. 4.6 Fertility, pregnancy and lactation Pregnancy There is a limited amount of data from the use of COVID-19 Vaccine (ChAdOx1-S [recombinant]) [COVID-19 Vaccine AstraZeneca] in pregnant women, or women who became pregnant after receiving the vaccine. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. 0000055862 00000 n >!V9j5LYHCz. ;BV Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. 0000024847 00000 n Each vial contains 8 doses of 0.5 ml. SR-3086-GB-0003 AstraZeneca UK Ltd, Medical Information Department Page 1 of 2 Last Updated January 7, 2021 Return to Index COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant]) - General Ingredients AstraZeneca is providing you with this material as an information service and professional courtesy. United Kingdom, MedImmune Pharma B.V., Nijmegen Dont worry we wont send you spam or share your email address with anyone. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. Once this enters the body, it tells your cells to make copies of the spike protein. WHO does not recommend discontinuing breastfeeding because of vaccination. This explainer is more than 90 days old. 0000098749 00000 n What is the evidence for use in older age groups? Younger patients may be more likely to experience anaphylaxis. However, a mild fever or infection, like a cold, are not reasons to delay vaccination; If you have ever had a condition known as heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2), or a blood clot in the sinus veins in the brain; If you have a problem with bleeding or bruising, or if you are taking a blood thinning medicine (anticoagulant); If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines). This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . 0000015573 00000 n vaccination series and are at higher risk of severe COVID-19 disease. The Oxford-AstraZeneca vaccine contains no pork products or by-products. The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. Route of administration Intramuscular injection. 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). 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 0000085176 00000 n endstream endobj startxref Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 0000001596 00000 n In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for Vaccine efficacy tended to be higher when the interval between doses was longer. Spills should be disinfected using agents with activity against adenovirus. The last nine ingredients on the list are called 'excipients.' %PDF-1.7 % 0000010323 00000 n 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. Contact your doctor or pharmacist if you have any questions about . This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. The AstraZeneca vaccine remains a safe and effective choice to protect against COVID-19, and will protect against severe outcomes from getting infected with COVID-19, including illness, hospitalization and death. /ID [<46442D36362D36432D33412D43412D36>] (Centers for Disease Control and Prevention). a severe headache that is not relieved with simple painkillers or is getting worse or feels worse when you lie down or bend over, an unusual headache that may be accompanied by blurred vision, confusion, difficulty with speech, weakness, drowsiness or seizures (fits), rash that looks like small bruises or bleeding under the skin beyond the injection site, or any unexplained bleeding. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. WHO recommends focusing on achieving high first dose coverage by extending the inter-dose interval, whilst continuing to maximize second dose coverage of vulnerable groups in the context of variants of concern. 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. 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 . Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: Well send you a link to a feedback form. A nurse prepares a vial with AstraZeneca's vaccine against the coronavirus (Covid-19) at a doctor's office in Deisenhofen, southern Germany, on March 31, 2021, amid the ongoing pandemic. Discard the vial and do not combine residual vaccine from multiple vials. 0000107012 00000 n 0000002960 00000 n The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. 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. Produced in genetically modified human embryonic kidney (HEK) 293 cells. 5. 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. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. . 0000004648 00000 n In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. 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. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Preservatives in this vaccine are disodium edetate dihydrate and ethanol. Available for Android and iOS devices. 0000106271 00000 n None of the ingredients in this vaccine can cause COVID-19. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. hb```(1A;B% 0000014217 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. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 0 EVIDENCE ASSESSMENT: BBIBP COVID-19 vaccine (BBIBP-CorV) Key evidence to inform policy recommendations on the use of BBIBP-CorV The SAGE Working Group specifically considered the following questions: 1. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine. 0000132021 00000 n In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Results from a large clinical trial in the United States and South America indicate that AstraZeneca's COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 0000015637 00000 n For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. 0000005556 00000 n Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 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. During use it can be stored from 2C to 25C. Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, possibly with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine and usually lasting for a day or two. Vaccine Maker Halts Trial Following Unexplained Illness in Volunteer, Details Emerge on Unexplained Illness in AstraZeneca COVID Vaccine Trial, A Study of a Candidate COVID-19 Vaccine (COV001), New Vaxzevria Data Further Support its Use as Third Dose Booster, Vaxzevria Significantly Boosted Antibody Levels Against Omicron, Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern, Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose, COVID-19 Vaccine AstraZeneca Effective Against Delta (Indian) Variant, AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan, AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy, AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis, UK and EU Regulatory Agencies Confirm COVID-19 Vaccine AstraZeneca is Safe and Effective, Update on the Safety of COVID-19 Vaccine AstraZeneca, AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX, AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization, COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials, COVID-19 Vaccine AstraZeneca Authorised for Use in the EU, COVID-19 Vaccine AstraZeneca Recommended for Use in the EU, Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZenecas COVID-19 Vaccine, AstraZenecas COVID-19 Vaccine Authorised for Emergency Supply in the UK, AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19, FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial, COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India, COVID-19 Vaccine AZD1222 Clinical Trials Resumed in the UK, Statement on AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause, AstraZenecas Scientific and Social Commitment for COVID-19 Vaccine AZD1222, Development of COVID-19 Vaccine AZD1222 Expands into US Phase III Clinical Trial Across All Adult Age Groups, AstraZeneca Australia & New Zealand Response to the COVID-19 Pandemic, AstraZeneca Concludes Agreement with the European Commission for the Supply of up to 400 Million Doses of AZD1222 COVID-19 Vaccine, COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial, Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate, AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford Universitys COVID-19 Vaccine At No Profit, AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford Universitys COVID-19 Vaccine, AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxfords Potential New Vaccine, Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia, AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine. 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