346 0 obj <> endobj << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> It uses a chimpanzee adenovirus to carry spike proteins from the . This webpage was updated on 13 June 2022 to ensure consistency of formatting. This will help to protect you against COVID-19 in the future. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. 0000004648 00000 n Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 0000102152 00000 n SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. 346 65 0000132090 00000 n This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). This means that it is essentially sodium-free. 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. %%EOF _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 0000003094 00000 n 0000005805 00000 n 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 <. Previous Name: ChAdOx1 nCoV-19 If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). hb```(1A;B% Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. This means that a COVID-19 vaccine cannot make you sick with COVID-19. 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. Cayman Chemical. Epub 2020 Dec 8. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. 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. 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.' COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). {zzZ`ntK?D6r|D#T$* TGBKz. Organization: Public Health Agency of Canada. 0000002028 00000 n If you are allergic to any of the active substances or any of the other ingredients listed in section 6. In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, 0000006617 00000 n xref i; "32tBa;CC'd&@u^?^02/g`8Ea?U Function. 0000012193 00000 n 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. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. Unit dose strength (s) > 0.7 1011 vp/mL. You have accepted additional cookies. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 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. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. 0000003890 00000 n M Ms CZHto ) are no data yet for Omicron. AstraZeneca vs. Sinovac side effects. Contents of the pack and other information 1. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 0000004413 00000 n Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000099076 00000 n WHO recommends the use of the ChAdOx1-S [recombinant] COVID-19 vaccine in pregnant women only when the benefits of vaccination to the pregnant woman outweigh the potential risks. 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). endstream For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. 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 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. Get urgent medical attention if you get symptoms of a severe allergic reaction. 3. 57 0 obj <> endobj xref Keep this leaflet. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: How to store COVID-19 Vaccine AstraZeneca 6. 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 . COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). 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. 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. 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. The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: 0000004761 00000 n These include: y 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. O'`` r/ RV"Lj~=n%8w?C * But individuals may choose to delay vaccination for 3 months following the infection. endobj 2020 has been a difficult year for all, but has seen 58 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) be developed and in clinical trials,1 with some vaccines reportedly having more than 90% efficacy against COVID-19 in clinical trials. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr 0000102287 00000 n However, it is not confirmed whether these events were due to the vaccine. If you get any side effects, talk to your doctor, pharmacist or nurse. This means that it is essentially 'sodium-free'.. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for It will take only 2 minutes to fill in. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. 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. If you are not sure, talk to your doctor, pharmacist or nurse. Some affected patients had a previous diagnosis of CLS. It causes the body to produce its own protection (antibodies) against the virus. Keep this medicine out of the sight and reach of children. You can help by reporting any side effects you may get. In countries with ongoing This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. Efficacy. The manufacturer URL for this document will be provided once that is available. Dont worry we wont send you spam or share your email address with anyone. 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. 0000001096 00000 n 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. hb```b``9 |Abl,=@00M(P~. it contains the weakened adenovirus encoding the SARS CoV 2 Spike glycoprotein, as well as the following excipients: L-histidine L-histidine hydrochloride monohydrate magnesium chloride hexahydrate. impact. Download PDF. 0000009283 00000 n Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd endstream endobj 76 0 obj <> stream See section 4. An email has been sent to you to confirm your subscription. Safety data sheet. stream Contact your doctor or pharmacist if you have any questions about . Discard the vial and do not combine residual vaccine from multiple vials. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. %PDF-1.7 The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. It is a summary of information about the drug and will not tell you everything about the drug. 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. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. xVN@}W#E{I HTJB+!`)m;:KQyX99se When these blood clots do occur, they may be in unusual or atypical locations (e.g. Updated on 13 June 2022 to ensure consistency of formatting. Please reach out if you have any feedback on the translation. 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