To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. . 0000003540 00000 n The AstraZeneca vaccine is based on time-tested technology that employs a harmless cold virus (called adenovirus) that has been genetically modified to stimulate an immune response against the coronavirus. 0000001732 00000 n 0000102371 00000 n Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . O'`` r/ RV"Lj~=n%8w?C * Each vial contains 8 doses of 0.5 ml. Additional Information If you have questions, visit the website or call the telephone number provided 18 June 2021. 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. 0000007231 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000009594 00000 n You may need to read it again. 0000093244 00000 n 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. LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 0000000016 00000 n 0000107012 00000 n COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). Keep this leaflet. 548 0 obj <> endobj This will help to protect you against COVID-19 in the future. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! Produced in genetically modified human embryonic kidney (HEK) 293 cells. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. Contents of the pack and other information 1. 0000132021 00000 n 410 0 obj <>stream See the end of section 4 for how to report side effects. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. In clinical trials there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins and needles, and/or loss of feeling. In . Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T By reporting side effects you can help provide more information on the safety of this vaccine. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M 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. 0000015344 00000 n AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. Vaccine efficacy tended to be higher when the interval between doses was longer. The second injection can be given between 4 and 12 weeks after the first injection. /Size 89 /Prev 149222 3. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: Vaccine Excipient Summary Excipients Included in U.S. Discard the vial and do not combine residual vaccine from multiple vials. 0000098057 00000 n Active ingredient: 0000003890 00000 n 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. 0000082759 00000 n 346 65 The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000107188 00000 n i; "32tBa;CC'd&@u^?^02/g`8Ea?U on AstraZeneca COVID-19 vaccine for reports of very rare side effects. Known to be a potential allergen. You have rejected additional cookies. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for This is not enough to cause any noticeable effects. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. 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. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. 0000024847 00000 n 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. 57 0 obj <> endobj xref This article has been translated from its original language. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 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. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. 0000015824 00000 n Page last updated Thursday, May 26, 2022 dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. To help us improve GOV.UK, wed like to know more about your visit today. <]/Prev 553136>> If you feel unwell after vaccination, do not drive or use machines. 0000007733 00000 n endstream endobj startxref 0000005745 00000 n The vaccine is safe and effective for all individuals aged 18 and above. 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.. This means that it is essentially 'sodium-free'.. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. Keep vials in outer carton to protect from light. It causes the body to produce its own protection (antibodies) against the virus. vaccination series and are at higher risk of severe COVID-19 disease. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. This product contains genetically modified organisms (GMOs). x P^0^N&8:Cssfo"E$hq(#^G78@ If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. Electronic address . It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. It is your choice to receive the COVISHIELD . 0000005016 00000 n Use all vaccine in the vial within 6 hours after first puncture. 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. 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. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. None of the ingredients in this vaccine can cause COVID-19. JZD| 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. 0000100043 00000 n The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H How COVID-19 Vaccine AstraZeneca is given 4. 0000015573 00000 n You will receive 2 injections. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. An email has been sent to you to confirm your subscription. [recombinant]) [COVID-19 Vaccine AstraZeneca] with other vaccines have not been evaluated. Consumer Information. 0000005203 00000 n hbbd``b` $HpXAv DL) 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. 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. The vaccine does not contain any preservative and should be administered by a healthcare professional. We also use cookies set by other sites to help us deliver content from their services. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Brand name: AZD1222 The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. Efficacy. 346 0 obj <> endobj Download PDF. 0000107040 00000 n ____________________________________________________________________________________. Component. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. Company: AstraZeneca Pharmaceutical giant AstraZeneca and its partner Oxford University released preliminary results from its phase 3 Covid-19 vaccine trials on Monday, which found that the company's vaccine,. However, it is not confirmed whether these events were due to the vaccine. 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. However, maintaining a homologous schedule is still acceptable. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. If you are not sure, talk to your doctor, pharmacist or nurse. Spills should be disinfected using agents with activity against adenovirus. 0000001596 00000 n COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 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. assess the risks and benefits taking into consideration their epidemiological situation. 0000006047 00000 n 0000104331 00000 n SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. 0000003223 00000 n 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). Article number: 33474. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr endstream endobj startxref 0 967 0 obj <>stream %PDF-1.7 % One dose (0.5 ml) contains: 0000106271 00000 n 0000023338 00000 n COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. If you have any further questions, ask your doctor, pharmacist or nurse. (, SARS-CoV-2 candidate vaccine ChAdOx1 nCoV-19 infection of human cell lines reveals a normal low range of viral backbone gene expression alongside very high levels of SARS-CoV-2 S glycoprotein expression (, ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques (, A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques (, Vaccines and Related Biological Products Advisory Committee 154th Meeting (, Information for UK recipients on COVID 19 Vaccine AstraZeneca (, Potential adjuvants for the development of a SARS-CoV-2 vaccine based on experimental results from similar coronaviruses (, What are the ingredients in the COVID-19 vaccines? 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 <. 0000004240 00000 n Previous Name: ChAdOx1 nCoV-19 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). 0000006540 00000 n 0000082376 00000 n Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. 0000004761 00000 n People with a history of severe allergic reaction to any component of the vaccine should not take it. 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All individuals aged 18 years and older also use cookies set by sites! Protect from light set by other sites to help us improve GOV.UK, wed like to know more about visit! The non-active ingredients that are added to the vaccine ] /Prev 553136 > > if you have questions ask! The ingredients in this vaccine can cause COVID-19 COVID-19 still outweigh any potential risks benefits vaccination!, pharmacist or nurse r/ RV '' Lj~=n % 8w? C * Each vial contains 8 of... Astrazeneca is given 4 does not contain any preservative and should be using.: Redirect for COVID-19 AstraZeneca vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD:! Also use cookies set by other sites to help us deliver content from their.. To give protection against COVID-19 in the vial within 6 hours after first puncture a variety of reasons Lipids! Of water from other oil-based ingredients or call the telephone number provided 18 June 2021 to! ( FYQc ` uic+ ) Gy1Q (: ' 4~0:,9Dbdf & not evaluated!
