This includes any possible side effects not listed in this leaflet. Can they overcome their checkered past? The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. WHO does not recommend discontinuing breastfeeding because of vaccination. Article number: 33474. The AstraZeneca vaccine has been made from a modified adenovirus which causes the common cold in chimpanzees, but specifically modified so that it cannot cause an infection. 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. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. AstraZeneca vs. Sinovac side effects. 0000002484 00000 n We use some essential cookies to make this website work. 0000132090 00000 n 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. 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. Vaccines, by Vaccine In addition to weakened or killed disease antigens (such as weakened, killed, or parts of viruses or bacteria), vaccines contain very small amounts of other ingredients - excipients. What COVID-19 Vaccine AstraZeneca is and what it is used for COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2). In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. In . 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. The vaccine is safe and effective for all individuals aged 18 and above. &Va(f+0&+FIcDHoL 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. 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. One dose (0.5 ml) contains: Success! 346 65 0000082759 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. xcbd```b``A$c0{.fH "uAY@1bFg210MW Consumer Information. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. Getty Images. 0000004240 00000 n This product contains genetically modified organisms (GMOs). The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 0000093244 00000 n 2. Talk to the healthcare provider if you have questions. If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms. None of the ingredients in this vaccine can cause COVID-19. 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. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 0000001096 00000 n LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T 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. Vaccines are generally very safe and their study involves a rigorous process. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. The Anglo-Swedish firm has . 0000011249 00000 n 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. How to store COVID-19 Vaccine AstraZeneca 6. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. 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.. M Ms CZHto ) endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream Most people have been exposed to them in their lives. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000004124 00000 n COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). For instance, preservatives prevent the vaccine from going bad or being spoiled. information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. Any unused vaccine or waste material should be disposed of in accordance with local requirements. xc```b``g`a```d@ A+s4@s60J:Up95PA? x P^0^N&8:Cssfo"E$hq(#^G78@ 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. 0000100169 00000 n What is the evidence for vaccine efficacy and safety in adults (18-59 years)? 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. EDTA is not listed as an ingredient in the Johnson &. The expiry date refers to the last day of that month. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 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. 0000013285 00000 n No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. i; "32tBa;CC'd&@u^?^02/g`8Ea?U 0000025064 00000 n You may need to read it again. %PDF-1.3 % 4 to 12 weeks. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Generic name: SARS-CoV-2 vaccine Some of the information might be out of date or no longer relevant. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. Published: 2021-05-07. 0000003223 00000 n Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. 11 Apr 2021. . 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. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. 0000083589 00000 n 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. 0000107040 00000 n 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. 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 It causes the body to produce its own protection (antibodies) against the virus. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 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 . This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w endstream endobj startxref 0000004159 00000 n endstream November 2020 - Trial data dispute. 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. Use all vaccine in the vial within 6 hours after first puncture. The second injection can be given between 4 and 12 weeks after the first injection. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. 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. Spills should be disinfected using agents with activity against adenovirus. You have rejected additional cookies. 0000006540 00000 n 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). Epub 2020 Dec 8. 0 Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. %%EOF These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. Previous Name: ChAdOx1 nCoV-19 , ,p This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. k [ 0000106271 00000 n 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. 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. However, a causal relationship with the vaccine has neither been confirmed nor ruled out and more rigorous studies are needed to fully assess the significance of With Australia's COVID vaccine rollout slowly getting underway, what's inside the Pfizer and Astrazeneca jabs is the question now front and centre for a growing number of people hesitant about getting the vaccination.. Understanding the ingredients of the vaccines being offered in Australia requires a basic understanding of how vaccines work in general. 0000000016 00000 n are no data yet for Omicron. 0000006617 00000 n 0000012641 00000 n In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for During use it can be stored from 2C to 25C. 0000102287 00000 n endstream endobj 347 0 obj <>/Metadata 343 0 R/Outlines 30 0 R/OutputIntents[<>]/Pages 342 0 R/StructTreeRoot 38 0 R/Type/Catalog>> endobj 348 0 obj <>/Font<>>>/Fields[]>> endobj 349 0 obj <. endstream endobj 780 0 obj <. It uses a dead version of the SARS -CoV-2 virus so that it cannot replicate, but it keeps the surface spike protein intact to trigger the body's immune system. Vaccine AstraZeneca and those who received control. 0000006590 00000 n 0000007733 00000 n 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. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Summary. Route of administration Intramuscular injection. Liverpool, L24 9JW This means that it is essentially 'sodium-free'.. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . The average age of those who have experienced severe allergic reactions so far is . Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine, Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Novavax vaccine against COVID-19: What you need to know, The Bharat Biotech BBV152 COVAXIN vaccine against COVID-19: What you need to know, Independent Oversight and Advisory Committee, WHO Strategic Advisory Group of Experts on Immunization (SAGE), Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the ChAdOx1-S [recombinant] vaccine against COVID-19 (AstraZeneca COVID-19 vaccine AZD1222 Vaxzevria, SII COVISHIELD), The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Uncommon (infrequent) >1/1000 and < 1/100, The Astra-Zeneca vaccine recommendations have also been modified to indicate that either of the mRNA COVID-19 vaccines (Pfizer or Moderna) can be used as a second dose following a, The Astra-Zeneca vaccine can be used as a. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). If you miss a scheduled injection, you may not be fully protected against COVID-19. 0000005203 00000 n The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. If you are not sure, talk to your doctor, pharmacist or nurse. <>/Metadata 30 0 R>> 0000081617 00000 n Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: 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 . 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. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. endobj %PDF-1.7 % COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). Oops! This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. "It can't give you an infection. 0000004761 00000 n trailer Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000003465 00000 n >!V9j5LYHCz. ;BV py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( 18 June 2021. Countries should SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. The AstraZeneca vaccine is made up of a number of ingredients, including an active ingredient called an 'antigen' and several other non-active ingredients called 'excipients.' 0000001605 00000 n Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. 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. The vaccine does not contain any preservative and should be administered by a healthcare professional. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. None of the ingredients in this vaccine can cause COVID-19. $x >HdA@; 0000103016 00000 n 0000018147 00000 n Moderna COVID-19 vaccine. 346 0 obj <> endobj The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. (, 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? 0000003094 00000 n 0000003743 00000 n 0000097826 00000 n 0 0000104953 00000 n Safety data sheet. /Root 55 0 R Dosage level (s) 5 1010 vp (nominal). 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. Published March 31, 2021 Updated Aug. 1, 2021. Company: AstraZeneca COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). 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. Once the vaccine has undergone Phase 3 testing, the manufacturer can apply for a license from regulatory authorities (like the FDA in the US) to make the vaccine available for public use. Once this enters the body, it tells your cells to make copies of the spike protein. 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. 0000003715 00000 n 0 Page last updated Thursday, May 26, 2022 0000005805 00000 n trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. For countries that have not yet achieved high vaccine coverage rates in the high-priority groups and that are experiencing high incidence of COVID-19 cases combined with vaccine supply constraints, longer intervals i.e. 0000012193 00000 n SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. To help us improve GOV.UK, wed like to know more about your visit today. "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary <]/Prev 553136>> Organization: Public Health Agency of Canada. Once approved, the drugmaker will work with national governments and international health organizations to monitor vaccine recipients for potential side effects from the vaccine that were not seen in clinical trials (this is called surveillance). If you are immunocompromised and receive a third dose of COVID-19 Vaccine AstraZeneca, it may still not provide full immunity to COVID-19 and you should continue to maintain physical precautions to help prevent COVID-19. 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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