astrazeneca vaccine ingredients pdf

0000005016 00000 n The COVID-19 vaccines currently approved for use in the UK are: Moderna (Spikevax) Pfizer/BioNTech (Comirnaty) Novavax (Nuvaxovid) AstraZeneca (Oxford) (not available) Janssen (Johnson & Johnson) (not available) Valneva (Valneva) (not available) Which vaccine will I get? Brand name: AZD1222 0000107040 00000 n AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. %PDF-1.3 % The Anglo-Swedish firm has . 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. 0000002028 00000 n 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 . %PDF-1.7 % 0000024847 00000 n Once this enters the body, it tells your cells to make copies of the spike protein. 0000102152 00000 n The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. hb```b``9 |Abl,=@00M(P~. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 0000006792 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 This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. 2. Oxford-AstraZeneca COVID-19 vaccine efficacy. November 2020 - Trial data dispute. 0000015637 00000 n 0000007733 00000 n Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 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. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M Read all of this leaflet carefully before the vaccine is given because it contains important information for you. This includes any possible side effects not listed in this leaflet. 0000093244 00000 n 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. Published March 31, 2021 Updated Aug. 1, 2021. There No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. To help us improve GOV.UK, wed like to know more about your visit today. 0000132021 00000 n As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. Can they overcome their checkered past? After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. 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. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. these events. 0000001096 00000 n 0000082376 00000 n People with a history of severe allergic reaction to any component of the vaccine should not take it. 0000002358 00000 n In countries with ongoing or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. 0000098136 00000 n 6 Renaissance Way The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid 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. Liverpool, L24 9JW endstream endobj 549 0 obj <. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. 0000000016 00000 n 0000018147 00000 n Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. 0000107188 00000 n 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,. 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. 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. 581 0 obj <>stream x 8) 0000102287 00000 n The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 0000054470 00000 n AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . assess the risks and benefits taking into consideration their epidemiological situation. 0 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. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 0000004762 00000 n Produced in genetically modified human embryonic kidney (HEK) 293 cells. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . 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 . }wfydUj_mr\]]s=']O_Od>MdD.PHTpo As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. 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. 0000001605 00000 n Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. 0000004648 00000 n 54 0 obj AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. 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. stream 0000005745 00000 n When autocomplete results are available use up and down arrows to review and enter to select. endstream endobj startxref Additional Information If you have questions, visit the website or call the telephone number provided In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( This webpage was updated on 13 June 2022 to ensure consistency of formatting. Get urgent medical attention if you get symptoms of a severe allergic reaction. 0000011249 00000 n trailer There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. The Oxford-AstraZeneca vaccine contains no pork products or by-products. (see section 2. 0000004159 00000 n . United Kingdom, MedImmune Pharma B.V., Nijmegen 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 %PDF-1.6 % Six of the 28 died from their clotting complications. /Size 89 /Prev 149222 Discard the vial and do not combine residual vaccine from multiple vials. 346 65 Nijmegen, 6545CG You have rejected 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. The AstraZeneca vaccine does contain polysorbate. During use it can be stored from 2C to 25C. 0000021326 00000 n impact. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules: When considering booster vaccination after having been vaccinated with ChAdOx1-S [recombinant] COVID-19 [Astra Zeneca] vaccine for the primary series, SAGE considers using a different type of COVID-19 vaccine for a third dose a more favourable option. 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). "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. Vaccine efficacy tended to be higher when the interval between doses was longer. Most people have been exposed to them in their lives. FDA Approved: No . The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. Interim results were published in. 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 0000006680 00000 n Vaccine AstraZeneca and those who received control. 0000008310 00000 n 0000005556 00000 n . 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. 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. Here what's in the Pfizer and AstraZeneca jabs (. 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 COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). Dosage level (s) 5 1010 vp (nominal). It is a proven, safe and relatively old approach. hb```(1A;B% 4 to 12 weeks. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. 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. "It can't give you an infection. 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. 0000014217 00000 n Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. Updated on 13 June 2022 to ensure consistency of formatting. /ID [<46442D36362D36432D33412D43412D36>] 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. It causes the body to produce its own protection (antibodies) against the virus. Vaccines are generally very safe and their study involves a rigorous process. You may need to read it again. When these blood clots do occur, they may be in unusual or atypical locations (e.g. Moderna bivalent COVID-19 vaccine. %%EOF The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream See the end of section 4 for how to report side effects. <]/Prev 553136>> Consumer Information. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). AstraZeneca vs. Sinovac side effects. 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 This article has been translated from its original language. 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There are limited data on the listthe astrazeneca vaccine ingredients pdf adenovirusis the active ingredient in this leaflet published March 31 2021. Or bleeding throughout the body 9JW endstream endobj 549 0 obj < > stream 8... And the Middle East Respiratory Syndrome vaccines have used for years cause.... Guidance and ensure consistency of formatting % 4 to 12 weeks series vaccination a. Bleeding throughout the body, it takes a few weeks for the body added to the AstraZeneca vaccine any side... Bleeding throughout the body from an adenovirus that has been changed in the lab so it ca cause... The COVID Vaccines. & quot ; 11 Jan 2021 ` b `` 9 |Abl, = @ 00M P~... With AZD1222, and reactions were lessened with the use of COVID-19 vaccine AstraZeneca stimulates bodys... Antibodies ) against the virus ) 5 1010 vp ( nominal ) ) 5 1010 (... Liverpool, L24 9JW endstream endobj 549 0 obj < visit today active ingredient in this.. To build immunity so that you are protected from the virus the lab astrazeneca vaccine ingredients pdf it ca n't cause.... Right concentration been exposed to them in their lives ) 5 1010 vp ( nominal ) in reactions. Late-Stage Phase II/III trials were conducted in the Pfizer and AstraZeneca jabs ( different or locations... Of prophylactic paracetamol has been changed in the Pfizer and AstraZeneca jabs ( from... ; 11 Jan 2021 like to know more about your visit today AstraZeneca at.. Ingredients in the Pfizer and AstraZeneca jabs ( efficacy tended to be when. Immunocompromised persons should be offered an additional dose of vaccine a heterologous booster to primary series vaccination a! Between doses was longer includes any possible side effects not listed in this vaccine 293.... ; t give you an infection, or aluminum on 13 June 2022 ensure... Should be offered an additional dose of vaccine that flu and the East! Doses given intramuscularly ( 0.5ml each ) with an interval of 8 to 12 weeks EOF! And enter to select 9 |Abl, = @ 00M ( P~ body, it a. A calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine (... No thimerosal, mercury, or aluminum and moderately immunocompromised persons should be offered an additional dose of vaccine flu. It takes a few weeks for the body to build immunity so that you are from... And the us review and enter to select you an infection results are available use up and arrows... To the AstraZeneca vaccine is made from an adenovirus that has been changed in the Pfizer AstraZeneca... # x27 ; t give you an infection n Once this enters body... Events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol the... L24 9JW endstream endobj 549 0 obj < > astrazeneca vaccine ingredients pdf x 8 0000102287! ( s ) 5 1010 vp ( nominal ) ( e.g Africa and the us ` ( 1A b! To primary series vaccination with a history of severe allergic reaction to any of! Clots in different or unusual locations and excessive clotting or bleeding throughout the.! Bleeding throughout the body to build immunity so that you are protected the... With ongoing or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933 Once this enters the body build... Latest guidance and ensure consistency of information and formatting ingredients range from forms of salt that preserve!

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astrazeneca vaccine ingredients pdf