0000001596 00000 n For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. health workers and immunocompromised persons should be prioritised. 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.' This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. Get urgent medical attention if you get symptoms of a severe allergic reaction. Vaccine AstraZeneca in children and adolescents younger than 18 years of age. WHO does not recommend pregnancy testing prior to vaccination. Previous Name: ChAdOx1 nCoV-19 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. 0000009880 00000 n 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. /Size 89 /Prev 149222 Cayman Chemical. 0000010323 00000 n 0000098749 00000 n 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. 0000014217 00000 n ]0[ assess the risks and benefits taking into consideration their epidemiological situation. An email has been sent to you to confirm your subscription. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . 0000081617 00000 n 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. 0000004124 00000 n xcbd```b``A$c0{.fH "uAY@1bFg210MW See section 4. 0000004240 00000 n On his way to a meeting to present . << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 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. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T %PDF-1.3 % Brand name: AZD1222 The vaccine does not contain any preservative and should be administered by a healthcare professional. Seek immediate medical attention if you develop these symptoms in the days following vaccination. %PDF-1.7 % 0000100169 00000 n The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 2. If you get any side effects, talk to your doctor, pharmacist or nurse. 0000132021 00000 n endstream endobj 75 0 obj <> stream It's only capable of delivering the DNA," he said. 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 . SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 18 June 2021. 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 Liverpool, L24 9JW 0000083589 00000 n COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). Safety data sheet. In countries with ongoing endstream 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. Younger patients may be more likely to experience anaphylaxis. 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. 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. Active ingredient: 0000093244 00000 n 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. 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. Side effects for many of the vaccines currently available for COVID-19 are similar, with injection site pain and soreness leading the most common reactions . startxref /Root 55 0 R 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). Generic name: SARS-CoV-2 vaccine Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. these events. Updated on 13 June 2022 to ensure consistency of formatting. 0000002358 00000 n {zzZ`ntK?D6r|D#T$* TGBKz. This means that it is essentially sodium-free. The Anglo-Swedish firm has . 0000004761 00000 n Some excipients are added to a vaccine for a specific purpose. 3. The manufacturer URL for this document will be provided once that is available. 3. 11 Apr 2021. 0000019840 00000 n 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. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w We also use cookies set by other sites to help us deliver content from their services. Vaccine AstraZeneca and those who received control. endstream endobj startxref Article number: 33474. stream 0000004648 00000 n "It can't give you an infection. 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). 0000006617 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. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. Like all medicines, this vaccine can cause side effects, although not everybody gets them. Vaccines are generally very safe and their study involves a rigorous process. Providing this Health information in your inbox, every other week. Vaccine efficacy tended to be higher when the interval between doses was longer. Nijmegen, 6545CG The last nine ingredients on the list are called 'excipients.' 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. Dosage level (s) 5 1010 vp (nominal). 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. 0000005016 00000 n Read all of this leaflet carefully before the vaccine is given because it contains important information for you. 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. 0000001732 00000 n FDA Approved: No trailer 0000004159 00000 n At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. The vaccine is safe and effective for all individuals aged 18 and above. endobj 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. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. 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. . $x >HdA@; It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. You can change your cookie settings at any time. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. Each vial contains 10 doses of 0.5 ml. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. It is a summary of information about the drug and will not tell you everything about the drug. 0000003715 00000 n Dont worry we wont send you spam or share your email address with anyone. Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. WHO does not recommend discontinuing breastfeeding because of vaccination. 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. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 56 0 obj This is not enough to cause any noticeable effects. endobj 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. 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 This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 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. 870 0 obj <>stream No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. 0000007733 00000 n 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. One dose (0.5 ml) contains: s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 0000015824 00000 n This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. Most people have been exposed to them in their lives. To help pregnant women make this assessment, they should be provided with AstraZeneca . endstream endobj 76 0 obj <> stream COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, This product contains genetically modified organisms (GMOs). Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Keep this medicine out of the sight and reach of children. Route of administration Intramuscular injection. 0 Moderna bivalent COVID-19 vaccine. 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. Some cases had a fatal outcome. Published: 2021-05-07. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. Spills should be disinfected using agents with activity against adenovirus. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. AstraZeneca-Oxford vaccine was 76% effective at preventing symptomatic COVID-19 two weeks after the second dose and was 100% effective in stopping severe disease and hospitalization in a. This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. i; "32tBa;CC'd&@u^?^02/g`8Ea?U This type of vaccine development technology has been tested for many other diseases such as influenza (flu) and Middle East respiratory syndrome coronavirus (MERS-CoV). Known to be a potential allergen. After withdrawing the final dose, some liquid may remain in the vial. Page last updated Thursday, May 26, 2022 If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. 0000003223 00000 n Epub 2020 Dec 8. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. 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). Solution for injection. %%EOF How to store COVID-19 Vaccine AstraZeneca 6. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. By reporting side effects you can help provide more information on the safety of this vaccine. A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. There If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. <>/Metadata 30 0 R>> 0 57 0 obj <> endobj xref Browse our homepage for up to date content or request information about a specific topic from our team of scientists. (see section 2. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream &Va(f+0&+FIcDHoL The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for use of the Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1-S [recombinant] vaccine). The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. 0000107012 00000 n M Ms CZHto ) Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. vaccination series and are at higher risk of severe COVID-19 disease. Produced in genetically modified human embryonic kidney (HEK) 293 cells. 0000055862 00000 n %%EOF The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. See the end of section 4 for how to report side effects. 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. Consumer Information. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . This article has been translated from its original language. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. . Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 0000006792 00000 n (Centers for Disease Control and Prevention). hb``g``oc`c` @1v=k}u F'SUNZ COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 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. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 0000006540 00000 n The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 0000003094 00000 n During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 0000001096 00000 n ____________________________________________________________________________________. Any unused vaccine or waste material should be disposed of in accordance with local requirements. %%EOF 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). 0000023338 00000 n This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. None of the ingredients in this vaccine can cause COVID-19. 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 0000000016 00000 n %PDF-1.7 % Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. It is a proven, safe and relatively old approach. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 0000088968 00000 n As new data become available, WHO will update recommendations accordingly. 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June 2022 to ensure consistency of formatting you return for your second injection of COVID-19 vaccine Lancet! Vaccination in protecting against COVID-19 far outweighs the risks and benefits taking into consideration their epidemiological situation are called.!

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