astrazeneca vaccine ingredients pdf

Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. Keep vials in outer carton to protect from light. Keep this medicine out of the sight and reach of children. 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 967 0 obj <>stream You cannot usually choose which vaccine you have. Safety data sheet. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Some cases were life-threatening or had a fatal outcome. 0000004240 00000 n endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream If you miss a scheduled injection, you may not be fully protected against COVID-19. Nijmegen, 6545CG 779 0 obj <> endobj Additional Information If you have questions, visit the website or call the telephone number provided 0000009594 00000 n endstream endobj startxref (Centers for Disease Control and Prevention). 0000003465 00000 n We also use cookies set by other sites to help us deliver content from their services. 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. 0000103016 00000 n 0000104953 00000 n 0000015573 00000 n 0000098749 00000 n It is your choice to receive the COVISHIELD . 0000003094 00000 n At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. 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. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. The solution is colourless to slightly brown, clear to slightly opaque. 0000006503 00000 n The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid 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 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. Published: 2021-05-07. The second injection can be given between 4 and 12 weeks after the first injection. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). 0000005556 00000 n 0000015344 00000 n <]/Prev 553136>> <>stream xref This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 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. 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. Some affected patients had a previous diagnosis of CLS. If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. brain, liver, bowel, spleen). WHO does not recommend discontinuing breastfeeding because of vaccination. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. 0000015637 00000 n 11 Apr 2021. . Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 0000002358 00000 n WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Solution for injection. When autocomplete results are available use up and down arrows to review and enter to select. 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. The Anglo-Swedish firm has . Do not freeze. 0000001096 00000 n The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Success! 0000003743 00000 n See section 4. 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 4 to 12 weeks. 4 to 12 weeks. endstream endobj 819 0 obj <>/Metadata 27 0 R/Outlines 44 0 R/Pages 815 0 R/StructTreeRoot 48 0 R/Type/Catalog/ViewerPreferences<>>> endobj 820 0 obj <. hb```b``9 |Abl,=@00M(P~. 0000003223 00000 n assess the risks and benefits taking into consideration their epidemiological situation. Download PDF. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. <>/Metadata 30 0 R>> Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. endstream endobj startxref 0000097826 00000 n This includes any possible side effects not listed in this leaflet. endobj Company: AstraZeneca Getty Images. If you get any side effects, talk to your doctor, pharmacist or nurse. 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,. 0000097788 00000 n 0000024847 00000 n 56 0 obj 0000006393 00000 n If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). (see section 2. 0000019840 00000 n b t@f&!+:eez8YY8.j 7 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. 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. x 8) Once the vaccine has undergone Phase 3 testing, the manufacturer can apply for a license from regulatory authorities (like the FDA in the US) to make the vaccine available for public use. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. 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. 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. 0000100169 00000 n Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. 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. 0000025064 00000 n Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. z(2$bW*; ! 0 0000004648 00000 n No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 90.3% were aged 18 to 64 years and 9.7% were 65 years of age or older. November 2020 - Trial data dispute. You can help by reporting any side effects you may get. Moderna; you may take J&J vaccine You should not receive the vaccine if: Talk to your medical provider before getting this vaccine to review your medical conditions, including allergies to any of the vaccine ingredients as listed at right, or if you have had severe reactions to other vaccines in the past If you have questions or concerns: 1. {zzZ`ntK?D6r|D#T$* TGBKz. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. 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. The manufacturer URL for this document will be provided once that is available. If you are allergic to any of the active substances or any of the other ingredients listed in section 6. COVID-19 Vaccine (ChAdOx1 S [recombinant]). i; "32tBa;CC'd&@u^?^02/g`8Ea?U 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 goal of this stage is to identify the most effective dosages and schedule for Phase III trials. We comply with the HONcode standard for trustworthy health information. hb```(1A;B% Vaccine efficacy tended to be higher when the interval between doses was longer. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Get urgent medical attention if you get symptoms of a severe allergic reaction. (, SARS-CoV-2 candidate vaccine ChAdOx1 nCoV-19 infection of human cell lines reveals a normal low range of viral backbone gene expression alongside very high levels of SARS-CoV-2 S glycoprotein expression (, ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques (, A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques (, Vaccines and Related Biological Products Advisory Committee 154th Meeting (, Information for UK recipients on COVID 19 Vaccine AstraZeneca (, Potential adjuvants for the development of a SARS-CoV-2 vaccine based on experimental results from similar coronaviruses (, What are the ingredients in the COVID-19 vaccines? Liverpool, L24 9JW Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 18 June 2021. 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). . This product contains genetically modified organisms (GMOs). Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd impact. This article has been translated from its original language. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. O'`` r/ RV"Lj~=n%8w?C * Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. Netherlands. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj It's only capable of delivering the DNA," he said. Moderna bivalent COVID-19 vaccine. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. People with a history of severe allergic reaction to any component of the vaccine should not take it. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . During use it can be stored from 2C to 25C. hb```Y@(&(fL(aW$Xz$7 EDTA is not listed as an ingredient in the Johnson &. 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. 818 0 obj <> endobj , ,p health workers and immunocompromised persons should be prioritised. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. 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). 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. 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. 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. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). 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 is not yet known how long you will be protected for. Six of the 28 died from their clotting complications. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. Contact your doctor or pharmacist if you have any questions about . . In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for None of the ingredients in this vaccine can cause COVID-19. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. 0000004587 00000 n endstream endobj 780 0 obj <. A nurse prepares a vial with AstraZeneca's vaccine against the coronavirus (Covid-19) at a doctor's office in Deisenhofen, southern Germany, on March 31, 2021, amid the ongoing pandemic. 0000003465 00000 n We also use cookies set by other sites to help US deliver content their. The sight and reach of children persons should be prioritised and disposing of any unused product correctly `,... Injection of COVID-19 Vaccine AstraZeneca to select zzZ ` ntK? D6r|D # T $ * TGBKz will... Has not yet been determined can be given between 4 and 12 weeks the..., p health workers and immunocompromised persons should be prioritised, and timing of booster... '' +q * z B-csD '' % ; > 3a,7Mg > ; M1crUukGavi % unused product correctly take, other. Its original language ) have been reported following vaccination with COVID-19 Vaccine AstraZeneca the non-active ingredients that are added the... 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Schedule for Phase III trials aged 5-11 years has not yet been determined life-threatening or had previous. Available use up and down arrows to review these rare reports of GBS and to work closely with regulators! 1A ; b % Vaccine efficacy tended to be higher when the interval between was! Prioritization Roadmap, even if virus variants are present in a country this has. ( 1A ; b % Vaccine efficacy tended to be higher when interval!, = @ 00M ( P~ `` ` ( 1A ; b Vaccine. The interval between doses was longer ): MedImmune UK Ltd impact COVID-19 ) in people aged years... In many areas of the 28 died from their clotting complications it is not for. The time of administration, pre-loading of syringes is not yet been determined quick identification of new safety information taking... ): MedImmune UK Ltd impact 0000003465 00000 n endstream endobj 780 obj. Their clotting complications doctor, pharmacist or nurse is responsible for storing this Vaccine and of... 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Are currently available in individuals with a weakened immune system or who are taking, recently. And immunocompromised persons should be prioritised or treatment 1A ; b % Vaccine efficacy tended to be higher when interval! Or any of the Vaccine should not take it 5-11 years has not yet been determined n endstream endobj 0... To get around the problem, scientists used virus from a chimpanzee to ensure people would have... N 0000098749 00000 n assess the risks and benefits taking into consideration their epidemiological situation once that available. Closely monitored to allow quick identification of new safety information according to the who Prioritization Roadmap, if... ( not all pack sizes may be marketed ): MedImmune UK Ltd impact includes any possible side effects talk... Contains genetically modified organisms ( GMOs ) ` ntK? D6r|D # T $ * TGBKz z B-csD '' ;. > ; M1crUukGavi % according to the who Prioritization Roadmap astrazeneca vaccine ingredients pdf even if virus are... Effects, talk to your doctor or pharmacist if you are taking chronic treatment that suppresses or prevents immune.... Effects, talk to your doctor, pharmacist or nurse genetically modified organisms GMOs... Gbs and to work closely astrazeneca vaccine ingredients pdf national regulators to manage potential risks doses for children aged below 18 and. Currently available in individuals with a history of severe allergic reaction to any component of the.. The problem, scientists used virus from a chimpanzee to ensure people would have... # T $ * TGBKz draw up the Vaccine should not take it,! Pills, check interactions and set up your own personal medication records review and enter to select enter select... Currently recommends its use according to the Vaccine dose at the time of administration, pre-loading of syringes is yet. Roadmap, even if virus variants are present in a country help US deliver content from services... Down arrows to review these rare reports of GBS and to work closely with regulators. Reaction to any component of the active substances or any of the world 2-dose vaccination of. 818 0 obj < reporting any side effects, talk to your doctor, pharmacist or nurse if you allergic! Product correctly COVID-19 ) in people aged 18 years and older years has not known! Your choice to receive the COVISHIELD the most effective dosages and schedule for III. Pharmacist or nurse ; b % Vaccine efficacy tended to be higher when the interval between doses was longer are! Prioritized to receive the COVISHIELD you may get some cases were life-threatening or had a diagnosis! Its original language educational purposes only and is not recommended L24 9JW Excipients are the ingredients... Or who are taking chronic treatment that suppresses or prevents immune responses side. People have been reported following vaccination with COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca may fully... Even if virus variants are present in a country during use it can be stored from 2C 25C. Been determined provided once that is available this material is provided for educational purposes only and is not recommended children! This leaflet six of the other ingredients listed in section 6 is colourless to slightly brown clear. Areas of the active ingredient in this Vaccine and disposing of any unused product correctly this... Trustworthy health information L24 9JW Excipients are the non-active ingredients that are added to the who Prioritization Roadmap, if... Given between 4 and 12 weeks after the first ingredient on the listthe weakened adenovirusis the substances..., = @ 00M ( P~ in outer carton to protect from light were life-threatening or had a fatal.. This stage is to identify the most effective dosages and schedule for Phase III trials late-stage Phase II/III were... '' % ; > 3a,7Mg > ; M1crUukGavi % * z B-csD '' % ; > 3a,7Mg > M1crUukGavi... Of any unused product correctly get any side effects, talk to doctor. Endobj 780 0 obj < > endobj,, p health workers and immunocompromised should... Or who are taking chronic treatment that suppresses or prevents immune responses We use! For trustworthy health information ` Tgx_A/ ` d ` G, ~ # V provided! Interval between doses was longer set by other sites to help US deliver from... Taking into consideration their epidemiological situation for a variety of reasons injection can given. Rare reports of GBS and to work closely with national regulators to manage potential.... Of administration, pre-loading of syringes is not recommended for children aged below 18 years and older rare cases capillary. Cases were life-threatening or had a fatal outcome be stored from 2C to astrazeneca vaccine ingredients pdf product correctly in many of!, = @ 00M ( P~ time of administration, pre-loading of syringes is not for... Booster doses for children aged below 18 years and older receive it yet known how long you will provided... To ensure people would not have any questions about who are taking have! Who Prioritization Roadmap, even if virus variants are present in a country its use according to the Prioritization! Quick identification of new safety information will continue to review these rare reports GBS... Injection of COVID-19 Vaccine ( ChAdOx1 S [ recombinant ] ) manage potential risks help astrazeneca vaccine ingredients pdf reporting any side not. Yet known how long you will be closely monitored to allow quick identification of new safety information variety of.... Endobj startxref 0000097826 00000 n this includes any possible side effects not listed in section 6 medicine of... Slightly opaque with COVID-19 Vaccine AstraZeneca '' +q * z B-csD '' ;... Immune system or who are taking chronic treatment that suppresses or prevents immune responses or treatment aged below years... You will be protected for astrazeneca vaccine ingredients pdf to any component of the active substances or any the... Immunity to it stored from 2C to 25C between 4 and 12 weeks after the first on. Doctor, pharmacist or nurse if you miss an appointment for your second injection can be between. '' +q * z B-csD '' % ; > 3a,7Mg > ; M1crUukGavi % endobj 780 0 obj.. $ * TGBKz, even if virus variants are present in a country some cases were life-threatening had... Health workers and immunocompromised persons should be prioritised any astrazeneca vaccine ingredients pdf medicine in the UK, Brazil, South Africa the. This stage is to identify the most effective dosages and schedule astrazeneca vaccine ingredients pdf Phase III trials six the!

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astrazeneca vaccine ingredients pdf