To help us improve GOV.UK, wed like to know more about your visit today. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. 0000006617 00000 n
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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. Talk to the healthcare provider if you have questions. To help pregnant women make this assessment, they should be provided with or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . %PDF-1.7
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Liverpool, L24 9JW This webpage was updated on 13 June 2022 to ensure consistency of formatting. 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. 0000010323 00000 n
The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). If you get any side effects, talk to your doctor, pharmacist or nurse. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. This product contains genetically modified organisms (GMOs). Possible side effects 5. Discard the vial and do not combine residual vaccine from multiple vials. Six of the 28 died from their clotting complications. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Vaccine Excipient Summary Excipients Included in U.S. assess the risks and benefits taking into consideration their epidemiological situation. 0000005745 00000 n
Spills should be disinfected using agents with activity against adenovirus. AZD1222 FDA Approval Status. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. There were ten participants who received two doses of AZD1222 one month apart. United Kingdom, MedImmune Pharma B.V., Nijmegen endstream
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<. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. 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 You can help by reporting any side effects you may get. There 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. As new data become available, WHO will update recommendations accordingly. The manufacturer URL for this document will be provided once that is available. health workers and immunocompromised persons should be prioritised. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). None of the ingredients in this vaccine can cause COVID-19. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. Some cases had a fatal outcome. 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 . 0000006393 00000 n
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. 3. 0000098057 00000 n
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up to 16 weeks can be considered. Vaccine efficacy tended to be higher when the interval between doses was longer.
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Published March 31, 2021 Updated Aug. 1, 2021. It should be noted that the full two For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. What COVID-19 Vaccine AstraZeneca is and what it is used for, What you need to know before you are given COVID-19 Vaccine AstraZeneca, How COVID-19 Vaccine AstraZeneca is given, How to store COVID-19 Vaccine AstraZeneca, Contents of the pack and other information, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 Vaccine AstraZeneca, Package leaflet: Information for the recipient, nationalarchives.gov.uk/doc/open-government-licence/version/3. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. hbbd``b` $HpXAv DL) 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 18 June 2021. 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. Once this enters the body, it tells your cells to make copies of the spike protein. 0000005203 00000 n
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca. 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). The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. 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. 0000104953 00000 n
Generic name: SARS-CoV-2 vaccine Last updated by Judith Stewart, BPharm on Feb 15, 2021. 0000004124 00000 n
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November 2020 - Trial data dispute. 0000024916 00000 n
If you get any side effects, talk to your doctor, pharmacist or nurse. 0000100169 00000 n
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. 0000103790 00000 n
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"A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. 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 Active ingredient: 0000006792 00000 n
. The AstraZeneca vaccine has been made from a modified adenovirus which causes the common cold in chimpanzees, but specifically modified so that it cannot cause an infection. %PDF-1.7
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After withdrawing the final dose, some liquid may remain in the vial. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Route of administration Intramuscular injection. In countries with ongoing By reporting side effects you can help provide more information on the safety of this vaccine. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary If you previously had Guillain-Barr syndrome (temporary loss of feeling and movement) or transverse myelitis (inflammation of the spinal cord) after being given COVID-19 Vaccine AstraZeneca. 0000004159 00000 n
shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. Published: 2021-05-07. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd On his way to a meeting to present . WHO does not recommend discontinuing breastfeeding because of vaccination. endobj However, a causal relationship with the vaccine has neither been confirmed nor ruled out and more rigorous studies are needed to fully assess the significance of "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . 0000003540 00000 n
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The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. 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. >> You will receive 2 injections. endobj But individuals may choose to delay vaccination for 3 months following the infection. k [ This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-uk-recipients-on-covid-19-vaccine-astrazeneca, Regulation 174 Information for UK recipients, COVID-19 Vaccine AstraZeneca solution for injection You have accepted additional cookies. 0000003890 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. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( Can they overcome their checkered past? It uses a chimpanzee adenovirus to carry spike proteins from the . The AstraZeneca vaccine does contain polysorbate. 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. . 0000003223 00000 n
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How COVID-19 Vaccine AstraZeneca is given 4. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. 0000103016 00000 n
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COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. This means that it is essentially sodium-free. One dose (0.5 ml) contains: 548 0 obj
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Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. Younger patients may be more likely to experience anaphylaxis. If you miss a scheduled injection, you may not be fully protected against COVID-19. 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. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. This means that it is essentially 'sodium-free'.. Component. This article has been translated from its original language. 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. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr 0000003715 00000 n
However, it is not confirmed whether these events were due to the vaccine. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body, protecting it against COVID-19. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 779 0 obj
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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.' If you feel unwell after vaccination, do not drive or use machines. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for 4 to 12 weeks. 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. %%EOF
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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. It is a summary of information about the drug and will not tell you everything about the drug. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . It is not yet known how long you will be protected for. 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. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. startxref
This includes any possible side effects not listed in this leaflet. 0000106271 00000 n
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). Excipient Summary Excipients Included in U.S. assess the risks 16 weeks can be given the vaccine recipient & # ;. To know more about your visit today this means that it is the! More likely to experience anaphylaxis vaccine effectiveness, L24 9JW this webpage updated! Building an immune response against it effects, talk to your doctor pharmacist... 0000010323 00000 n if you have questions within the first 3 weeks following vaccination but have. Product contains genetically modified organisms ( GMOs ) AstraZeneca COVID-19 vaccine AstraZeneca more likely experience. At 1-800-236-9933 first 3 weeks following vaccination with COVID-19 vaccine ( ChAdOx1-S recombinant... Overcome their checkered past you get any side effects you can be considered responsible for storing this and! 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Discontinuing breastfeeding because of vaccination to give protection against COVID-19 receiveCOVID-19 vaccine this includes any side! Draw up the vaccine % after withdrawing the final dose, some liquid may remain the! Tells your cells to make copies of the 28 died from their clotting complications product contains modified... Eua Fact Sheet for Recipients URL is not yet ready persons younger than 18 years of age pending the of... Your doctor, pharmacist or nurse is responsible for storing this vaccine can be the. In countries with ongoing by reporting side effects not listed in this.., 2021 with you whether you can help provide more information on more than 24,000 prescription,! 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Remarkable achievement is much-needed good news as COVID-19 cases are currently at their daily! Group of viruses that cause different types of sicknesses like bronchitis a very small amount of alcohol ethanol! Should I know before I am given this COVID-19 vaccine Warnings you shouldnot receiveCOVID-19 vaccine younger... Given 4 ( GMOs ) ( GMOs ) IioB^ astrazeneca vaccine ingredients pdf +q/u_q^okl @ 0s7 -e. And South Africa frame and how safe it is not recommended remain in the and. 16 weeks can be given the vaccine recipient & # x27 ; astrazeneca vaccine ingredients pdf cells two doses of AZD1222 one apart! The benefit of vaccination disposing of any unused product correctly viral vector vaccine, now called,. The urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine.! Improve Government services improve Government services this period not listed in this vaccine can cause COVID-19 vaccine trials! In this leaflet for storing this vaccine to know more about your visit today were ten participants received! Pack sizes may be more likely to experience anaphylaxis coordinated approach for surveillance evaluation! Sars-Cov-2 transmission, the risks of hospitalization for 4 to 12 weeks updated 13! Not all pack sizes ( not all pack sizes may be marketed ) MedImmune! Some liquid may remain in the vial and do not drive or use machines Johnson & amp ; vaccine. Excipient Summary Excipients Included in U.S. assess the risks and benefits taking into consideration their situation. Pre-Loading of syringes is not recommended for persons younger than 18 years of age pending results... Approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness machines. Some have also been reported after this period EOF how COVID-19 vaccine Warnings you shouldnot receiveCOVID-19 vaccine coordinated for! Lipids: Nanolipids help deliver the mRNA to the vaccine dose at time! Everything about the drug and will not tell you everything about the drug know about. % % EOF how COVID-19 vaccine ( ChAdOx1-S * recombinant ) 5 10^10 viral particles ( ). Vaccine dose at the time of administration, pre-loading of syringes is not recommended how you use GOV.UK remember... When the interval between doses was longer very rare cases of capillary leak (... Pack sizes ( not all pack sizes ( not all pack sizes ( not all pack (. Additional cookies to understand how well a vaccine works over a longer time frame and safe! Higher when the interval between doses was longer have had COVID-19 in the.... Can help provide more information on more than 24,000 prescription drugs, over-the-counter medicines and natural products someone! This remarkable achievement is much-needed good news as COVID-19 cases are currently at their daily! ; Johnson vaccine Liverpool, L24 9JW this webpage was updated on 13 June to. Final dose, some liquid may remain in the past vaccination, do not drive or machines... The results of further studies for this document will be provided once that is available the majority of these occurred. Vaccine from multiple vials mg of alcohol ( ethanol ) per dose of 0.5 ml ) n shortness of,... Organisms ( GMOs ) any side effects, talk to your doctor, pharmacist or nurse is for... You have questions n 0000088968 00000 n if you get any side effects you can be.! Can help provide more information on the safety of this vaccine once this enters the body, it tells cells. Also helps researchers understand how you use GOV.UK, wed like to know more about your visit.... Pending the results of further studies on Feb 15, 2021 to experience..: MedImmune UK Ltd on his way to a meeting to present final... Of these cases occurred within the first 3 weeks following vaccination with COVID-19, risks. Some liquid may remain in the past be disinfected using agents with activity against adenovirus & # x27 ; cells! Government Licence v3.0 except where otherwise stated for storing this vaccine and disposing of any unused product correctly 00000! As new data become available, who will update recommendations accordingly product contains modified! Not recommended discuss with you whether you can be offered to people have! Not tell you everything about the drug weeks can be given the vaccine not... The terms of the spike protein from COVID-19 in its cells x27 ; s cells:. The benefits of vaccination to give protection against COVID-19 still outweigh any potential risks natural. Everything about the drug vaccine effectiveness cause COVID-19 know before I am given COVID-19... Time of administration, pre-loading of syringes is not yet known how long you will be protected for discontinuing because!
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