0000006503 00000 n Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. Known to be a potential allergen. Netherlands. You will receive 2 injections. . 0000025064 00000 n 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. A new investigational treatment for COVID-19: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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). The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Epub 2020 Dec 8. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj these events. 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. 0000004648 00000 n EVIDENCE ASSESSMENT: BBIBP COVID-19 vaccine (BBIBP-CorV) Key evidence to inform policy recommendations on the use of BBIBP-CorV The SAGE Working Group specifically considered the following questions: 1. 0000093244 00000 n Providing this There were ten participants who received two doses of AZD1222 one month apart. 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. 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. If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. 0000003540 00000 n xref Download PDF. You may need to read it again. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. 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. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. endstream 0000003094 00000 n 0000006617 00000 n Seek immediate medical attention if you develop these symptoms in the days following vaccination. You can help by reporting any side effects you may get. 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. 0000054208 00000 n Each vial contains 8 doses of 0.5 ml. 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. 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. 0000100043 00000 n /Size 89 /Prev 149222 Previous Name: ChAdOx1 nCoV-19 Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. 0000011249 00000 n Some excipients are added to a vaccine for a specific purpose. The manufacturer URL for this document will be provided once that is available. [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 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. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. However, it is not confirmed whether these events were due to the vaccine. %PDF-1.7 % (Centers for Disease Control and Prevention). Oxford-AstraZeneca COVID-19 vaccine efficacy. 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. Last updated by Judith Stewart, BPharm on Feb 15, 2021.. FDA Approved: No Brand name: AZD1222 Generic name: SARS-CoV-2 vaccine Previous Name: ChAdOx1 nCoV-19 Company: AstraZeneca Treatment for: Prevention of COVID-19 AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. %PDF-1.7 % 0000001096 00000 n WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. &Va(f+0&+FIcDHoL 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. 0000024916 00000 n - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. Any unused vaccine or waste material should be disposed of in accordance with local requirements. 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. 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. It uses a chimpanzee adenovirus to carry spike proteins from the . COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). %%EOF 0000003715 00000 n 0000019840 00000 n 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. startxref In . The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. If you have any further questions, ask your doctor, pharmacist or nurse. hb```Y@(&(fL(aW$Xz$7 0000002484 00000 n 0000013285 00000 n 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). << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] You have accepted additional cookies. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. . Interim results were published in. 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. 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. 0000098749 00000 n Vaccines are generally very safe and their study involves a rigorous process. 0000015824 00000 n %%EOF or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. %PDF-1.6 % For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . FDA Approved: No i; "32tBa;CC'd&@u^?^02/g`8Ea?U 0000005203 00000 n This means that a COVID-19 vaccine cannot make you sick with COVID-19. The vaccine is safe and effective for all individuals aged 18 and above. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. 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. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. You may access the guidance document here. Please reach out if you have any feedback on the translation. 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. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream It is designed for consumers and care givers. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. WHO does not recommend pregnancy testing prior to vaccination. 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. With Australia's COVID vaccine rollout slowly getting underway, what's inside the Pfizer and Astrazeneca jabs is the question now front and centre for a growing number of people hesitant about getting the vaccination.. Understanding the ingredients of the vaccines being offered in Australia requires a basic understanding of how vaccines work in general. 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