. hb``g``oc`c` @1v=k}u F'SUNZ 0000000016 00000 n 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 Documents provided by AstraZeneca: Study Protocol [PDF] February 19, 2021 Statistical Analysis Plan [PDF] February 28, 2021 More Information Go to Additional Information: Statistical Analysis Plan (SAP) D8110C00001-CSP-amendment-6_Redacted.pdf CSR Synopsis Publications: CDC. 0000004159 00000 n 0000001605 00000 n Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. FDA Approved: No 0000097826 00000 n Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX The manufacturer URL for this document will be provided once that is available. endstream 0000085176 00000 n /Size 89 /Prev 149222 To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. The second injection can be given between 4 and 12 weeks after the first injection. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo 0000006503 00000 n It's only capable of delivering the DNA," he said. %%EOF 0000107012 00000 n << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 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. This means that it is essentially sodium-free. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . %PDF-1.7 % 0000010323 00000 n /Info 87 0 R 0000007190 00000 n hb```b``9 |Abl,=@00M(P~. A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. If you are not sure, talk to your doctor, pharmacist or nurse. 0000002960 00000 n 0000009792 00000 n 0000056130 00000 n Get urgent medical attention if you get symptoms of a severe allergic reaction. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . <>/Metadata 30 0 R>> 0000100043 00000 n brain, liver, bowel, spleen). %PDF-1.7 % 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 new investigational treatment for COVID-19: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. {zzZ`ntK?D6r|D#T$* TGBKz. 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. %PDF-1.7 The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). Moderna COVID-19 vaccine. It is designed for consumers and care givers. 0000132090 00000 n It uses a chimpanzee adenovirus to carry spike proteins from the . trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). 0000018147 00000 n On his way to a meeting to present . All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. 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. 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. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . This includes any possible side effects not listed in this leaflet. Keep this medicine out of the sight and reach of children. What is the evidence for use in older age groups? up to 16 weeks can be considered. 0000005805 00000 n Produced in genetically modified human embryonic kidney (HEK) 293 cells. 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. 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. 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. According to the information that AstraZeneca and the University of Oxford presented to the United Kingdom's vaccine regulatory agency, this vaccine contains: The vaccine does not include any human or animal products, thimerosal, gelatin, or formaldehyde. 0000098877 00000 n Dont worry we wont send you spam or share your email address with anyone. 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. You have rejected additional cookies. Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. How to store COVID-19 Vaccine AstraZeneca 6. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. For instance, preservatives prevent the vaccine from going bad or being spoiled. 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. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. 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 <. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream 0000000016 00000 n 0000024847 00000 n Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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,. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. If you have any further questions, ask your doctor, pharmacist or nurse. 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 vaccine does not contain any preservative and should be administered by a healthcare professional. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. Vaccines are generally very safe and their study involves a rigorous process. As new data become available, WHO will update recommendations accordingly. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 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