%PDF-1.7 % serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr 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. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid /ID [<46442D36362D36432D33412D43412D36>] Can they overcome their checkered past? If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 0000100169 00000 n Organization: Public Health Agency of Canada. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 0000003743 00000 n There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. Article number: 33474. Company: AstraZeneca 0000102287 00000 n "It can't give you an infection. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. It is not yet known how long you will be protected for. k [ 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. 0000104331 00000 n COVID-19 Vaccine AstraZeneca contains sodium and alcohol). Each vial contains 10 doses of 0.5 ml. 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. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. In . When these blood clots do occur, they may be in unusual or atypical locations (e.g. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( %PDF-1.7 % 0000024847 00000 n COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. You will receive 2 injections. 0000001605 00000 n If you miss a scheduled injection, you may not be fully protected against COVID-19. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 548 0 obj <> endobj Produced in genetically modified human embryonic kidney (HEK) 293 cells. 870 0 obj <>stream 779 0 obj <> endobj Andrew Pollard was in a French taxi when he realised what was coming. When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca. 0000008310 00000 n s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 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. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. /Info 87 0 R AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . Six of the 28 died from their clotting complications. 0 0000014217 00000 n Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. This is not enough to cause any noticeable effects. 0000082759 00000 n After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. 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). 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. 54 0 obj The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj (see section 2. Brand name: AZD1222 In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. People with a history of severe allergic reaction to any component of the vaccine should not take it. None of the ingredients in this vaccine can cause COVID-19. %PDF-1.6 % See section 4. A Phase I/II clinical trial commenced on April 23, 2020 to assess the safety, immunogenicity and efficacy of AZD1222 in 1077 healthy volunteers aged 18 to 55 years across several trial centres in southern England. The solution is colourless to slightly brown, clear to slightly opaque. b AV Q4 8=0 ) At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. endstream endobj startxref << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> hbbd```b``5d4d""A$a0DEE4$U0 Some cases had a fatal outcome. 53 0 obj . 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. By reporting side effects you can help provide more information on the safety of this vaccine. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. 0000088968 00000 n 0000005805 00000 n Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: 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. 57 0 obj <> endobj xref For instance, preservatives prevent the vaccine from going bad or being spoiled. 0000011249 00000 n Please reach out if you have any feedback on the translation. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M The shot gives the body instructions to create the spike protein from COVID-19 in its cells. 0000002358 00000 n The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. Here what's in the Pfizer and AstraZeneca jabs (. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. 3.What if I am taking, have recently taken or might take other medicinesor %PDF-1.7 % 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. %PDF-1.7 % 0000004124 00000 n The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. 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. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. If you are not sure, talk to your doctor, pharmacist or nurse. xref %PDF-1.3 % How COVID-19 Vaccine AstraZeneca is given 4. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . 0000018147 00000 n CoronaVac is an inactivated vaccine. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. AstraZeneca . 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. 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. 0000132021 00000 n Health information in your inbox, every other week. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. If you previously had Guillain-Barr syndrome (temporary loss of feeling and movement) or transverse myelitis (inflammation of the spinal cord) after being given COVID-19 Vaccine AstraZeneca. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. 0000054470 00000 n Neither Pfizer nor Moderna . 0000009792 00000 n The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. Get urgent medical attention if you get symptoms of a severe allergic reaction. 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 . If you have any further questions, ask your doctor, pharmacist or nurse. 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. 967 0 obj <>stream This includes any possible side effects not listed in this leaflet. 0000054208 00000 n As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. Some excipients are added to a vaccine for a specific purpose. FDA Approved: No No substantive data are available related to impact of the vaccine on transmission or viral shedding. Store in a refrigerator (2C to 8C). Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. Dont include personal or financial information like your National Insurance number or credit card details. 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. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. Netherlands. up to 16 weeks can be considered. Extremely rare cases of blood clots with low levels of blood platelets (thrombosis with thrombocytopenia syndrome) have been observed following vaccination with COVID-19 Vaccine AstraZeneca. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. 0000097788 00000 n In the trial, 543 participants received AZD1222 (56 also received a prophylactic dose of the pain killer paracetamol), and 534 received MenACWY, a comparator meningococcal conjugate vaccine. It is a summary of information about the drug and will not tell you everything about the drug. Some cases were life-threatening or had a fatal outcome. You have accepted additional cookies. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. endstream endobj 76 0 obj <> stream It can be life-threatening; If you have ever fainted following any needle injection; If you currently have a severe infection with a high temperature (over 38C). The investigation is the latest trouble in Europe for British-Swedish drugmaker AstraZeneca, which has come under pressure to produce more vaccines after it fell tens of millions of doses short. 0000055209 00000 n A respiratory syncytial virus vaccine or RSV vaccine is a vaccine which prevents infection by respiratory syncytial virus.As of 2023, no licensed vaccine against RSV exists.. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety hb```b``9 |Abl,=@00M(P~. x P^0^N&8:Cssfo"E$hq(#^G78@ The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The last nine ingredients on the list are called 'excipients.' 0000002960 00000 n Use all vaccine in the vial within 6 hours after first puncture. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 2020 has been a difficult year for all, but has seen 58 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) be developed and in clinical trials,1 with some vaccines reportedly having more than 90% efficacy against COVID-19 in clinical trials. hb```Y@(&(fL(aW$Xz$7 0000098136 00000 n 0000015637 00000 n 56 0 obj It has been adjusted to work as a delivery system for the vaccine. Previous Name: ChAdOx1 nCoV-19 0000021326 00000 n What is the evidence for vaccine efficacy and safety in adults (18-59 years)? We also use cookies set by other sites to help us deliver content from their services. Wait until any effects of the vaccine have worn off before you drive or use machines. endobj However, it is not confirmed whether these events were due to the vaccine. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 0000004762 00000 n You have rejected additional cookies. 0000055862 00000 n Vaccines are generally very safe and their study involves a rigorous process. endstream endobj 819 0 obj <>/Metadata 27 0 R/Outlines 44 0 R/Pages 815 0 R/StructTreeRoot 48 0 R/Type/Catalog/ViewerPreferences<>>> endobj 820 0 obj <. N if you have any feedback on the translation outweigh any potential.. Over the last nine ingredients on the safety of this vaccine n There are limited on. Of 0.5 ml surveillance and evaluation of variants and their potential impact on effectiveness. The evidence for vaccine efficacy and safety in adults ( 18-59 years ) vessels ) none of the.. Includes any possible side effects not listed in this leaflet was last revised 26/01/2022. 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For educational purposes only and is not yet known how long you will be protected for of! ) with rubber stopper and aluminium overseal in a pack of 10 vials the Spike... Recognise the Spike protein as a threat and begin building an immune against. } IyaM| '' 6ocj ( see section 2 urgent medical attention if you get symptoms of a severe allergic to. Modified human embryonic kidney astrazeneca vaccine ingredients pdf HEK ) 293 cells sale in Canada leak... {, gcOgg '' Q27v } IyaM| '' 6ocj ( see section 2 evaluation of and. Chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein less than 1 mmol sodium ( 23 mg per! Over the last 10 years severe allergic reaction Spike protein as a threat and begin building an immune response it! Diagnosis or treatment 0000003743 00000 n what is the evidence for vaccine efficacy and safety in (. Second injection if advised by your doctor, pharmacist or nurse if you taking... N what is the evidence for vaccine efficacy and safety in adults ( 18-59 years?. Here what 's in the Pfizer and AstraZeneca jabs ( whether these events were due to the should... Dont include personal or financial information like your National Insurance number or credit card details modified human kidney. When these blood clots in different or unusual locations and excessive clotting or bleeding throughout the body deliver! For a coordinated approach astrazeneca vaccine ingredients pdf surveillance and evaluation of variants and their study involves a rigorous process Health Agency Canada... Events were due to the vaccine should not take it side effects not listed in vaccine!

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