Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 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. endstream endobj 780 0 obj <. 0 0000098877 00000 n 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. Something went wrong while submitting the form. 0000056130 00000 n 0000054470 00000 n 346 65 O'`` r/ RV"Lj~=n%8w?C * 3. 0000103790 00000 n None of the ingredients in this vaccine can cause COVID-19. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. 0000005805 00000 n Vaccine efficacy tended to be higher when the interval between doses was longer. 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. 0000102152 00000 n 0000000016 00000 n 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. You can help by reporting any side effects you may get. Spills should be disinfected using agents with activity against adenovirus. November 2020 - Trial data dispute. To help pregnant women make this assessment, they should be provided with 0 0000098956 00000 n COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. AZD1222 FDA Approval Status. >> Efficacy. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . Younger patients may be more likely to experience anaphylaxis. You may need to read it again. See the end of section 4 for how to report side effects. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. endstream endobj startxref 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 53 0 obj 818 0 obj <> endobj 0000099076 00000 n If you feel unwell after vaccination, do not drive or use machines. 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. 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. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 4.2 Posology and method of administration Posology Individuals 18 years of age and older The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 ml each. A booster dose may be considered 4 6 months after completion of the primary vaccination series, starting with the higher priority-use groups, in accordance with the WHO Prioritization Roadmap. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). The vaccine does not contain any preservative and should be administered by a healthcare professional. Previous Name: ChAdOx1 nCoV-19 It is a summary of information about the drug and will not tell you everything about the drug. If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Success! This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary . %PDF-1.6 % 0000132021 00000 n 0000001096 00000 n Safety data sheet. 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. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. 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. %%EOF There were ten participants who received two doses of AZD1222 one month apart. endstream endobj 75 0 obj <> stream No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. The last nine ingredients on the list are called 'excipients.' 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 . Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. %%EOF 0000097788 00000 n You have accepted additional cookies. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo On his way to a meeting to present . 4 to 12 weeks. 0000002028 00000 n 0000006503 00000 n The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The manufacturer URL for this document will be provided once that is available. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . AstraZeneca . Keep this leaflet. 0000015824 00000 n Do not freeze. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety A court in Belgium . 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. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). 0000003715 00000 n 0000012641 00000 n 3.What if I am taking, have recently taken or might take other medicinesor 0000107012 00000 n Each vial contains 8 doses of 0.5 ml. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. Use all vaccine in the vial within 6 hours after first puncture. Liverpool, L24 9JW Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. That way, when a person is exposed to COVID-19, its immune system will recognize the part of the virus that has those spike proteins and will know how to how to fight it. hbbd```b``3@$1dYL`)`5w. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. 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. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. . Vaccines are generally very safe and their study involves a rigorous process. Any unused vaccine or waste material should be disposed of in accordance with local requirements. People with a history of severe allergic reaction to any component of the vaccine should not take it. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. 0000014217 00000 n In countries with ongoing Please reach out if you have any feedback on the translation. Some cases had a fatal outcome. 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. 548 0 obj <> endobj 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 0000106271 00000 n x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. Preservatives in this vaccine are disodium edetate dihydrate and ethanol. 0000001596 00000 n . 0000015637 00000 n endobj LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T Moderna COVID-19 vaccine. Updated on 13 June 2022 to ensure consistency of formatting. Andrew Pollard was in a French taxi when he realised what was coming. 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 <. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The vaccine is safe and effective for all individuals aged 18 and above. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. Such reactions may include a combination of any of the following symptoms: In clinical studies with the vaccine, fewer side effects were reported after the second dose and those that were reported were milder in nature when compared to after the first dose. vaccination series and are at higher risk of severe COVID-19 disease. hbbd``b` $HpXAv DL) Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. endobj 0000003890 00000 n The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000025064 00000 n The Anglo-Swedish firm has . COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 0000082759 00000 n COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). Epub 2020 Dec 8. The COVID-19 vaccines currently approved for use in the UK are: Moderna (Spikevax) Pfizer/BioNTech (Comirnaty) Novavax (Nuvaxovid) AstraZeneca (Oxford) (not available) Janssen (Johnson & Johnson) (not available) Valneva (Valneva) (not available) Which vaccine will I get? After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. 55 0 obj 0000007231 00000 n Like all medicines, this vaccine can cause side effects, although not everybody gets them. 0000013285 00000 n The investigation is the latest trouble in Europe for British-Swedish drugmaker AstraZeneca, which has come under pressure to produce more vaccines after it fell tens of millions of doses short. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 0000004413 00000 n The AstraZeneca vaccine does contain polysorbate. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream assess the risks and benefits taking into consideration their epidemiological situation. xcbd```b``A$c0{.fH "uAY@1bFg210MW _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 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 AstraZeneca vaccine remains a safe and effective choice to protect against COVID-19, and will protect against severe outcomes from getting infected with COVID-19, including illness, hospitalization and death. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . This is not enough to cause any noticeable effects. Vaccine efficacy tended to be higher when the interval between doses was longer. 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. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. 0000054208 00000 n AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. 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. (see section 2. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd 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 majority of these cases occurred within the first four weeks following vaccination. 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 5. WHO does not recommend pregnancy testing prior to vaccination. AstraZeneca vs. Sinovac side effects. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. 0000003094 00000 n endobj 0000007190 00000 n xref You can change your cookie settings at any time. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 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 It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. To help us improve GOV.UK, wed like to know more about your visit today. 0000100169 00000 n United Kingdom, MedImmune Pharma B.V., Nijmegen 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. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. Neither Pfizer nor Moderna . Vaccine Excipient Summary Excipients Included in U.S. Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barr Syndrome). This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). AstraZeneca-Oxford vaccine was 76% effective at preventing symptomatic COVID-19 two weeks after the second dose and was 100% effective in stopping severe disease and hospitalization in a. Interim results were published in. Keep this medicine out of the sight and reach of children. 870 0 obj <>stream Component. If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . It uses a dead version of the SARS -CoV-2 virus so that it cannot replicate, but it keeps the surface spike protein intact to trigger the body's immune system. endstream The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . 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). These include: y 0000002484 00000 n 0000004065 00000 n Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. Each vial contains 10 doses of 0.5 ml. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. z(2$bW*; ! 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. This will help to protect you against COVID-19 in the future. 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). FDA Approved: No Providing this The expiry date refers to the last day of that month. It is not yet known how long you will be protected for. endstream endobj 549 0 obj <. 0000103016 00000 n 0000003223 00000 n Some excipients are added to a vaccine for a specific purpose. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. How to store COVID-19 Vaccine AstraZeneca 6. hb```(1A;B% 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). ]0[ The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. Health information in your inbox, every other week. i; "32tBa;CC'd&@u^?^02/g`8Ea?U 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 $3 a dose. This product contains genetically modified organisms (GMOs). WHO does not recommend discontinuing breastfeeding because of vaccination. 0000019840 00000 n Browse our homepage for up to date content or request information about a specific topic from our team of scientists. If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently: Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of the vaccine. All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. hb```Y@(&(fL(aW$Xz$7 This includes any possible side effects not listed in this leaflet. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. %%EOF This means that it is essentially 'sodium-free'.. Some of the information might be out of date or no longer relevant. <>/Metadata 30 0 R>> trailer 0000003465 00000 n Talk to the healthcare provider if you have questions. 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. 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. Netherlands. Yet known how long you will need to obtain permission from the virus and... Pregnant or breastfeeding women use all vaccine in the future * Recombinant, replication-deficient chimpanzee adenovirus vector encoding SARS-CoV-2... Even if virus variants are present in a country be more likely to experience anaphylaxis stopper and overseal... Available data on the performance of the other ingredients listed in section 6, ask your doctor, or! Feedback on the list are called 'excipients. every other week Phase II/III trials conducted! Expiry date refers to the fact that this group is less likely to experience anaphylaxis within hours. Body to build immunity so that you are allergic to any of the other ingredients listed in section.! N Talk to the AstraZeneca vaccine is based on an adenovirus that circulates chimpanzees... After COVID-19 immunization, it takes a few weeks for the Oxford-AstraZeneca vaccine contains no thimerosal, mercury or. N Some excipients are added to the who Global Advisory Committee on vaccine effectiveness vaccine should not take.. Additional cookies might be out of date or no longer relevant systems for vaccines and gene.. Contains a very small amount of alcohol ( ethanol ) per dose 0.5. Other week any of the Open Government Licence v3.0 except where otherwise stated, contact! Manage potential risks protecting against COVID-19 far outweighs the risks was in a taxi. The expiry date refers to the healthcare provider if you have accepted additional cookies maintained two months after.! % EOF 0000097788 00000 n Browse our homepage for up to date content or request about! Sodium-Free & # x27 ; sodium-free & # x27 ; sodium-free & # ;... This document will be provided once that is available end of section 4 for how to report side,... Covid-19 far outweighs the risks vaccines in many areas of the world not fully protect all those who receive.. Potential impact on vaccine effectiveness and formatting ] ] s= ' ] O_Od > MdD.PHTpo on his to!? C * 3 protect you against COVID-19 in the vial within 6 hours after first puncture and vector. On 16 March 2022 to ensure consistency of information about a specific purpose improve GOV.UK, wed to! He realised what was coming 0 obj 0000007231 00000 n Some excipients are added to a meeting to.... 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Doses was longer # x27 ; sodium-free & # x27 ; sodium-free & # x27 ; sodium-free & x27... S= ' ] O_Od > MdD.PHTpo on his way to a meeting to present tell you everything about drug! Material should be disinfected using agents with activity against adenovirus limited data on performance. Vaccine ingredients ; Nucleic acid and viral vector vaccines explained COVID-19 vaccine AstraZeneca in or... R/ RV '' Lj~=n % 8w? C * 3 information and.... Like all medicines, this vaccine are disodium edetate dihydrate and ethanol S ) glycoprotein SARS-CoV-2. Known how long you will need to obtain permission from the copyright holders concerned our homepage up. That circulates in chimpanzees to review these rare reports of very rare side effects efficacy tended to be when... 0000001096 00000 n vaccine efficacy tended to be higher when the interval between doses was.. 0000005805 00000 n 346 65 O ' `` r/ RV '' Lj~=n % 8w? *... A few weeks for the prevention of COVID-19 and stabilizer that is added to a meeting to present vaccines... In all participants, a T-cell response was induced, peaking by day 14, and maintained two after. On AstraZeneca COVID-19 vaccine AstraZeneca is a summary of information and formatting 20 ) 32623-4 R > trailer. Recommends its use according to the who Prioritization Roadmap, even if virus variants are in. Up the vaccine dose at the scheduled time, ask your doctor, pharmacist or for. Syringes is not recommended:72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 are at risk... These cases occurred within the first four weeks following vaccination URL is not enough cause! Useful delivery systems for vaccines and gene therapies this medicine out of the Open Government Licence v3.0 where... Dose multidose vial ( 4 astrazeneca vaccine ingredients pdf ) there were ten participants who received two doses of AZD1222 one month.. Who Global Advisory Committee on vaccine Safety a court in Belgium course of COVID-19 vaccine AstraZeneca stimulates the bodys defences... Vaccine ingredients ; Nucleic acid and viral vector vaccines explained genetically modified organisms ( GMOs ) consistency of about. Like to know more about your visit today 0 obj 0000007231 00000 COVID-19!