The AstraZeneca vaccine is based on time-tested technology that employs a harmless cold virus (called adenovirus) that has been genetically modified to stimulate an immune response against the coronavirus. The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. This will help to protect you against COVID-19 in the future. 0000100043 00000 n 0000006047 00000 n Generic name: SARS-CoV-2 vaccine 0000003890 00000 n ]0[ 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. /ID [<46442D36362D36432D33412D43412D36>] 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)). Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. 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. hbbd```b``3@$1dYL`)`5w. The AstraZeneca vaccine is made up of a number of ingredients, including an active ingredient called an 'antigen' and several other non-active ingredients called 'excipients.' x P^0^N&8:Cssfo"E$hq(#^G78@ Any unused vaccine or waste material should be disposed of in accordance with local requirements. You have rejected additional cookies. 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. Like any vaccine, the COVID-19 vaccines do come with potential side effects. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 0000001096 00000 n 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. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . startxref x 8) We comply with the HONcode standard for trustworthy health information. Known to be a potential allergen. 569 0 obj <>/Filter/FlateDecode/ID[<422DFA914F61AD45909E39C193482A39>]/Index[548 34]/Info 547 0 R/Length 105/Prev 177378/Root 549 0 R/Size 582/Type/XRef/W[1 3 1]>>stream Talk to the healthcare provider if you have questions. Possible side effects 5. 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. >!V9j5LYHCz. ;BV 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). 0000083589 00000 n A court in Belgium . 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. b t@f&!+:eez8YY8.j 7 6. 0000002484 00000 n One dose (0.5 ml) contains: No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. Safety data sheet. 0 0000103790 00000 n The vaccine is safe and effective for all individuals aged 18 and above. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. /Size 89 /Prev 149222 Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. 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). The shot gives the body instructions to create the spike protein from COVID-19 in its cells. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary Component. 0000000016 00000 n <>/Metadata 30 0 R>> %%EOF None of the ingredients in this vaccine can cause COVID-19. xc```b``g`a```d@ A+s4@s60J:Up95PA? Download PDF. . Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. 0000132090 00000 n 0000025064 00000 n 4 to 12 weeks. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( WHO does not recommend discontinuing breastfeeding because of vaccination. Liverpool, L24 9JW The expiry date refers to the last day of that month. 11 Apr 2021. United Kingdom, MedImmune Pharma B.V., Nijmegen Previous Name: ChAdOx1 nCoV-19 Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety 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. 0000004240 00000 n Published: 2021-05-07. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! Dosage level (s) 5 1010 vp (nominal). 0000104331 00000 n xref 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. 56 0 obj The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 0 Please reach out if you have any feedback on the translation. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). 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). 803 0 obj <>/Filter/FlateDecode/ID[<2F70D35E7B8A59458B52A8ED8203A71C><24F7C9D4F005C249BEA4CA3B57A534AF>]/Index[779 189]/Info 778 0 R/Length 129/Prev 229930/Root 780 0 R/Size 968/Type/XRef/W[1 3 1]>>stream Do not freeze. 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 ____________________________________________________________________________________. endobj %PDF-1.7 0000054208 00000 n 3. For instance, preservatives prevent the vaccine from going bad or being spoiled. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. k [ WHO does not recommend pregnancy testing prior to vaccination. 410 0 obj <>stream Page last updated Thursday, May 26, 2022 hb```(1A;B% Consumer Information. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 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 <. 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. RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H 0000006590 00000 n 0000012641 00000 n 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. 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. 0000012193 00000 n Updated on 13 June 2022 to ensure consistency of formatting. . 0000024916 00000 n 0000055209 00000 n 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. 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. 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). 0000001605 00000 n 0000015824 00000 n WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T $x >HdA@; What is the evidence for use in older age groups? 0000106271 00000 n COVID-19 Vaccine (ChAdOx1 S [recombinant]). 0000107040 00000 n Store in a refrigerator (2C to 8C). 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. %PDF-1.7 % Well send you a link to a feedback form. 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. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. 0 0000082376 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. endstream endobj startxref Andrew Pollard was in a French taxi when he realised what was coming. Function. 0000011249 00000 n 0000098057 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 . s/s's?3on1;XX(@?<=f@(tv4;r% ~IX xVN@}W#E{I HTJB+!`)m;:KQyX99se Additional Information If you have questions, visit the website or call the telephone number provided If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Contents of the pack and other information 1. Wait until any effects of the vaccine have worn off before you drive or use machines. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. endobj 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. 0000007231 00000 n 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. [recombinant]) [COVID-19 Vaccine AstraZeneca] with other vaccines have not been evaluated. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Six of the 28 died from their clotting complications. You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. If you have any further questions, ask your doctor, pharmacist or nurse. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. 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 This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . 0000088968 00000 n Interim results were published in. "It can't give you an infection. Article number: 33474. hbbd``b` $HpXAv DL) Getty Images. 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 In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M Cayman Chemical. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. ( 2C to 8C ) as practically possible and within 6 hours preservatives prevent the vaccine should be as. 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