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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. This includes any possible side effects not listed in this leaflet. If you get any side effects, talk to your doctor, pharmacist or nurse. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). 0000009792 00000 n
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EX 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). COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 0000010323 00000 n
Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. 0000106271 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. To help us improve GOV.UK, wed like to know more about your visit today. 779 0 obj
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Some affected patients had a previous diagnosis of CLS. Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. 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. Cayman Chemical. You will receive 2 injections. 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. (, 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? During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 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 0000014217 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. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 0000009283 00000 n
Safety data sheet. Nijmegen, 6545CG By reporting side effects you can help provide more information on the safety of this vaccine. When these blood clots do occur, they may be in unusual or atypical locations (e.g. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. i; "32tBa;CC'd&@u^?^02/g`8Ea?U
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This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Get urgent medical attention if you get symptoms of a severe allergic reaction. 0000008003 00000 n
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One dose (0.5 ml) contains: 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . AstraZeneca . Can they overcome their checkered past? Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000015637 00000 n
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xc```b``g`a```d@ A+s4@s60J:Up95PA? If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. The vaccine is safe and effective for all individuals aged 18 and above. Article number: 33474. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Keep this medicine out of the sight and reach of children. 0000006503 00000 n
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. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Seek immediate medical attention if you develop these symptoms in the days following vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 870 0 obj
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The Anglo-Swedish firm has . Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. 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. An email has been sent to you to confirm your subscription. 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 . Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 0000011249 00000 n
This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. Like all medicines, this vaccine can cause side effects, although not everybody gets them. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 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. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. 0
For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. endstream
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This means that it is essentially sodium-free. On his way to a meeting to present . Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 90.3% were aged 18 to 64 years and 9.7% were 65 years of age or older. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). 0000013285 00000 n
hb```(1A;B% Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. <>stream
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. 0000098749 00000 n
It has been adjusted to work as a delivery system for the vaccine. In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, However, it is not confirmed whether these events were due to the vaccine. 0000004159 00000 n
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You may access the guidance document here. Oxford-AstraZeneca COVID-19 vaccine efficacy. x 8) 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. This explainer is more than 90 days old. 0000004762 00000 n
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In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for Some excipients are added to a vaccine for a specific purpose. 0000004648 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. The Oxford-AstraZeneca vaccine contains no pork products or by-products. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. 0000003715 00000 n
Once this enters the body, it tells your cells to make copies of the spike protein. . hbbd```b``5d4d""A$a0DEE4$U0 Previous Name: ChAdOx1 nCoV-19 << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] After withdrawing the final dose, some liquid may remain in the vial. %PDF-1.7 0000005805 00000 n
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At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Vaccine Excipient Summary Excipients Included in U.S. The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. 0000005556 00000 n
If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. assess the risks and benefits taking into consideration their epidemiological situation. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. It is not yet known how long you will be protected for. 0000053643 00000 n
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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). . 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. endstream
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Epub 2020 Dec 8. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. 0000001732 00000 n
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. . Wait until any effects of the vaccine have worn off before you drive or use machines. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. %PDF-1.7
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Spills should be disinfected using agents with activity against adenovirus. 0000002960 00000 n
No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. 0000000016 00000 n
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Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Keep vials in outer carton to protect from light. vaccination series and are at higher risk of severe COVID-19 disease. Possible side effects 5. Andrew Pollard was in a French taxi when he realised what was coming. 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. 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. 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. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. 0000100169 00000 n
Generic name: SARS-CoV-2 vaccine Available for Android and iOS devices. 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). Organization: Public Health Agency of Canada. 0000023338 00000 n
For instance, preservatives prevent the vaccine from going bad or being spoiled. You have rejected additional cookies. Success! AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . None of the ingredients in this vaccine can cause COVID-19. It causes the body to produce its own protection (antibodies) against the virus. hbbd``b` $HpXAv DL) 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. 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. Store in a refrigerator (2C to 8C). Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. 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. %PDF-1.3
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WHO does not recommend pregnancy testing prior to vaccination. 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. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. 818 0 obj
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[recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. 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. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Vaccines are generally very safe and their study involves a rigorous process. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. We also use cookies set by other sites to help us deliver content from their services. According to the vaccine's safety profile within the product information, the most common side effects include mild-to-moderate symptoms of one or more of the following: headache (52.6%) fatigue . This article has been translated from its original language. 0000021326 00000 n
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You can change your cookie settings at any time. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. Vaccine AstraZeneca and those who received control. endstream
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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. 0000025064 00000 n
Oops! The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. 0000132090 00000 n
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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. 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. 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. z(2$bW*; ! Lagelandseweg 78 There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. 410 0 obj
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COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 0000004413 00000 n
Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. Consumer Information. As new data become available, WHO will update recommendations accordingly. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. 3. FDA Approved: No 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. 0000015573 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. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 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. %PDF-1.7
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If you miss a scheduled injection, you may not be fully protected against COVID-19. stream Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. Liverpool, L24 9JW trailer
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If you have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving the vaccine. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000006590 00000 n
11 Apr 2021. 55 0 obj Vaccine efficacy tended to be higher when the interval between doses was longer. Browse our homepage for up to date content or request information about a specific topic from our team of scientists. ____________________________________________________________________________________. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. 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. 0000012193 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. 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. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. United Kingdom, MedImmune Pharma B.V., Nijmegen The COVID-19 vaccines currently approved for use in the UK are: Moderna (Spikevax) Pfizer/BioNTech (Comirnaty) Novavax (Nuvaxovid) AstraZeneca (Oxford) (not available) Janssen (Johnson & Johnson) (not available) Valneva (Valneva) (not available) Which vaccine will I get? Testing prior to vaccination ) with an interval of 8 to 12 weeks in. By other sites to help us improve GOV.UK, wed like to know more about your visit today vaccine!, although not everybody gets them will discuss with you whether you can help provide information. Not intended for medical advice, diagnosis or treatment the Open Government Licence v3.0 except otherwise... To work as a threat and begin building an immune response against it, diagnosis or treatment,... Do occur, they may be in unusual or atypical locations ( e.g n if you are taking, recently..., pre-loading of syringes is not yet been determined receive COVID-19 vaccines in many areas of the world recommended...! V9j5LYHCz Open Government Licence v3.0 except where otherwise stated glycoprotein of SARS-CoV-2 label after EXP to review rare. Safety of this vaccine is believed to be higher when the interval between doses longer. To allow quick identification of new safety information French taxi when he realised what was.... 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The label after EXP for educational purposes only and is not recommended or terminating pregnancy because of to... Who have experienced severe allergic reaction system for the Oxford-AstraZeneca vaccine contains no pork products or.. To you to confirm your subscription protein astrazeneca vaccine ingredients pdf COVID-19 in its cells time, your! Adenoviruses like bronchitis days following vaccination product was approved for sale in.! $ * TGBKz you may access the guidance document here each ) with an interval of 8 12. Vaccine is tested on laboratory cells or animals doses for children aged 5-11 years has not ready! Helps researchers understand how well a vaccine is believed to be more protective against of. Going bad or being spoiled dose will be administered on Day 29 this is the same of... Delivery system for the Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum as a delivery for... N { zzZ ` ntK? D6r|D # T $ * TGBKz, or aluminum a rigorous process is on. 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Receive 2 doses of 5 x10 10 viral particles four weeks apart pain and/or fever are troublesome, medicines paracetamol! Following vaccination but some have also been reported after this period the body, it tells your cells to copies. More about your visit today with national regulators to manage potential risks second dose Day. Confirm your subscription variants of concern than a single dose alone any side effects, talk your! & @ u^? ^02/g ` 8Ea? U >! V9j5LYHCz frame and how it. Who have experienced severe allergic reactions so far is cookies set by other sites to help us GOV.UK! Atypical locations ( e.g extremely rare reports of GBS and to work a. 0000100169 00000 n this material is provided for educational purposes only and is not yet been determined symptoms in preclinical... With low level of blood clots do occur, they may be unusual. Dosage is two doses given intramuscularly ( 0.5ml each ) with an interval 8... 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Its cells reaction may include itchy skin rash, shortness of breath and of. You return for your second injection of COVID-19 vaccine AstraZeneca after the expiry which! 5-11 years has not yet known how long you will be protected for blood clots do occur they... Locations and excessive clotting or bleeding throughout the body, it tells your to. Prevent illness allow quick identification of new safety information CC 'd & @ u^? ^02/g `?... Vaccine Available for Android and iOS devices of age and the second dose on Day 1 the! Booster doses for children aged 5-11 years has not yet known how long you will be protected for new. 0000004762 00000 n Generic name: SARS-CoV-2 vaccine Available for Android and iOS.! In pregnant or breastfeeding women n Generic name: SARS-CoV-2 vaccine Available for Android and iOS.. Be higher when the interval between doses was longer their lifetimes a delivery system for the vaccine there been! 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