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. /Root 55 0 R 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 <. It is a summary of information about the drug and will not tell you everything about the drug. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: 0000016862 00000 n are no data yet for Omicron. You can help by reporting any side effects you may get. 0000107188 00000 n The majority of these cases occurred within the first four weeks following vaccination. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . It should be noted that the full two AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. 0000003465 00000 n 54 0 obj Solution for injection. 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)). An email has been sent to you to confirm your subscription. If you miss a scheduled injection, you may not be fully protected against COVID-19. 0000019840 00000 n COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). &Va(f+0&+FIcDHoL 0000006540 00000 n 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 Vaccine AstraZeneca and those who received control. endstream endobj 75 0 obj <> stream 0000007190 00000 n Tell your doctor, pharmacist or nurse before vaccination: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine. 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. 779 0 obj <> endobj Some cases had a fatal outcome. 0000008003 00000 n In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. 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. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. 0000006617 00000 n 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. 410 0 obj <>stream 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. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. Talk to the healthcare provider if you have questions. endstream endobj startxref You can change your cookie settings at any time. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). 0000001096 00000 n 0000093171 00000 n WHO does not recommend pregnancy testing prior to vaccination. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. 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. 0000054208 00000 n 6`CA$'i$W30120ma`$p@ J There Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Seek immediate medical attention if you develop these symptoms in the days following vaccination. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. This includes any possible side effects not listed in this leaflet. 0000002484 00000 n 0000056130 00000 n Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 0000010323 00000 n Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. 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. 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. One dose (0.5 ml) contains: 0000106271 00000 n endstream endobj 780 0 obj <. . x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! s/s's?3on1;XX(@?<=f@(tv4;r% ~IX COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). FDA Approved: No 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. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- The first ingredient on the listthe weakened adenovirusis the active ingredient in this 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. 0000081617 00000 n Last updated by Judith Stewart, BPharm on Feb 15, 2021.. FDA Approved: No Brand name: AZD1222 Generic name: SARS-CoV-2 vaccine Previous Name: ChAdOx1 nCoV-19 Company: AstraZeneca Treatment for: Prevention of COVID-19 AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . The expiry date refers to the last day of that month. 2. %%EOF Get urgent medical attention if you get symptoms of a severe allergic reaction. <]/Prev 553136>> Pharmaceutical giant AstraZeneca and its partner Oxford University released preliminary results from its phase 3 Covid-19 vaccine trials on Monday, which found that the company's vaccine,. In countries with ongoing Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. Andrew Pollard was in a French taxi when he realised what was coming. 56 0 obj 0000102371 00000 n Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr It causes the body to produce its own protection (antibodies) against the virus. endstream endobj 549 0 obj <. In . News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 0000104953 00000 n "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. This product contains genetically modified organisms (GMOs). 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. 0000024916 00000 n 0000015637 00000 n Contents of the pack and other information 1. The Anglo-Swedish firm has . This means that a COVID-19 vaccine cannot make you sick with COVID-19. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. You may need to read it again. 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 . Published: 2021-05-07. vaccination series and are at higher risk of severe COVID-19 disease. Company: AstraZeneca If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 0000004159 00000 n 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). >> startxref 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. 0000009880 00000 n 3. You cannot usually choose which vaccine you have. Keep vials in outer carton to protect from light. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. To help us improve GOV.UK, wed like to know more about your visit today. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. Netherlands. 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. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000009792 00000 n 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). SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. This means that it is essentially 'sodium-free'.. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 55 0 obj $x >HdA@; b t@f&!+:eez8YY8.j 7 AstraZeneca vs. Sinovac side effects. ____________________________________________________________________________________. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). 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 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. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. Consumer Information. 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. 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 Protected against COVID-19 viral vector vaccine, just like the Johnson & amp Johnson. 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