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. 0000006540 00000 n Moderna bivalent COVID-19 vaccine. 0000006680 00000 n 3. 0 endstream endobj startxref 0000012193 00000 n 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. What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Some of the information might be out of date or no longer relevant. 0000006393 00000 n WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. hbbd``b` $HpXAv DL) /Info 87 0 R This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. Component. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). 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. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000023338 00000 n Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. CoronaVac is an inactivated vaccine. 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. 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. This article has been translated from its original language. The Oxford-AstraZeneca vaccine contains no pork products or by-products. >> Spills should be disinfected using agents with activity against adenovirus. It is a proven, safe and relatively old approach. . Netherlands. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca 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. 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). It should be noted that the full two 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. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid If you get any side effects, talk to your doctor, pharmacist or nurse. 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.' The manufacturer URL for this document will be provided once that is available. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. 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. up to 16 weeks can be considered. In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 548 0 obj <> endobj Solution for injection. Once this enters the body, it tells your cells to make copies of the spike protein. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. Function. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: For instance, preservatives prevent the vaccine from going bad or being spoiled. endobj AstraZeneca vs. Sinovac side effects. It is designed for consumers and care givers. 346 65 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). Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. ]0[ AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . endobj 0000003890 00000 n It's only capable of delivering the DNA," he said. 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 b t@f&!+:eez8YY8.j 7 x P^0^N&8:Cssfo"E$hq(#^G78@ 0000003094 00000 n Published March 31, 2021 Updated Aug. 1, 2021. Available for Android and iOS devices. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 0000006792 00000 n This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). 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. Seek immediate medical attention if you develop these symptoms in the days following vaccination. endstream endobj 75 0 obj <> stream Download PDF. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. 0000019840 00000 n Younger patients may be more likely to experience anaphylaxis. 0000132021 00000 n Efficacy. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. 0000005016 00000 n The vaccine is safe and effective for all individuals aged 18 and above. The Anglo-Swedish firm has . For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. However, maintaining a homologous schedule is still acceptable. 0000093244 00000 n In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for Cayman Chemical. 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. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. 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. Liverpool, L24 9JW 0000097826 00000 n Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. Vaccine AstraZeneca and those who received control. This includes any possible side effects not listed in this leaflet. Getty Images. Please reach out if you have any feedback on the translation. Lagelandseweg 78 %%EOF United Kingdom, MedImmune Pharma B.V., Nijmegen 0000009792 00000 n 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. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. 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 . xcbd```b``A$c0{.fH "uAY@1bFg210MW Oops! 0000004124 00000 n Success! Health information in your inbox, every other week. 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 <. Consumer Information. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 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. 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). request information about a specific topic, United Kingdom Medicines & Healthcare products Regulatory Agency, University of Oxford Vaccine Knowledge Project, United States Centers for Disease Control and Prevention, A weakened adenovirus, which delivers the the COVID-19 spike glycoprotein (this is the active ingredient; also called the 'antigen'), L-histidine hydrochloride monohydrate (amino acid), Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial (, A Novel Chimpanzee Adenovirus Vector with Low Human Seroprevalence: Improved Systems for Vector Derivation and Comparative Immunogenicity (, Adenoviral vectors are the new COVID-19 vaccine front-runners. You have accepted additional cookies. 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. The solution is colourless to slightly brown, clear to slightly opaque. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Last updated by Judith Stewart, BPharm on Feb 15, 2021. The vaccine does not contain any preservative and should be administered by a healthcare professional. 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. health workers and immunocompromised persons should be prioritised. 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. 0000107040 00000 n <]/Prev 553136>> 0000002028 00000 n << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 0000093171 00000 n As new data become available, WHO will update recommendations accordingly. 6 Renaissance Way This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. Article number: 33474. This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. The second injection can be given between 4 and 12 weeks after the first injection. . Some affected patients had a previous diagnosis of CLS. . Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. 0000055209 00000 n Organization: Public Health Agency of Canada. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. 0000007231 00000 n Keep this medicine out of the sight and reach of children. 818 0 obj <> endobj Some cases were life-threatening or had a fatal outcome. 0000014217 00000 n 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. If you feel unwell after vaccination, do not drive or use machines. 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. Brand name: AZD1222 This means that a COVID-19 vaccine cannot make you sick with COVID-19. 0000099076 00000 n That way, when a person is exposed to COVID-19, its immune system will recognize the part of the virus that has those spike proteins and will know how to how to fight it. are no data yet for Omicron. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. %PDF-1.7 % This means that it is essentially 'sodium-free'.. Some excipients are added to a vaccine for a specific purpose. Any unused vaccine or waste material should be disposed of in accordance with local requirements. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). A booster dose may be considered 4 6 months after completion of the primary vaccination series, starting with the higher priority-use groups, in accordance with the WHO Prioritization Roadmap. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). Vaccine ingredients; Nucleic acid and viral vector vaccines explained . Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. 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). /Root 55 0 R 0000083589 00000 n 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 . 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)). None of the ingredients in this vaccine can cause COVID-19. After withdrawing the final dose, some liquid may remain in the vial. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. Interim results were published in. You can change your cookie settings at any time. 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 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. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- 0000098877 00000 n 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). As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 0000103790 00000 n 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. O'`` r/ RV"Lj~=n%8w?C * Possible side effects 5. Dosage level (s) 5 1010 vp (nominal). 0000097788 00000 n If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. hb```Y@(&(fL(aW$Xz$7 When autocomplete results are available use up and down arrows to review and enter to select. 0000007733 00000 n AstraZeneca is a member of Covax, a global initiative aiming to distribute two billion vaccine doses to 92 low- and middle-income countries at no more than $3 a dose. startxref 0000000016 00000 n We use some essential cookies to make this website work. 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