0000004648 00000 n Each vial contains 8 doses of 0.5 ml. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. 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. Produced in genetically modified human embryonic kidney (HEK) 293 cells. Article number: 33474. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. %PDF-1.7 % 0000054470 00000 n b t@f&!+:eez8YY8.j 7 54 0 obj 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. k [ 57 40 In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. 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. endobj shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. As new data become available, WHO will update recommendations accordingly. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. 0000098877 00000 n This includes any possible side effects not listed in this leaflet. ____________________________________________________________________________________. 0000104953 00000 n xVN@}W#E{I HTJB+!`)m;:KQyX99se 0000006792 00000 n A court in Belgium . 0000011249 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. 3. . Neither Pfizer nor Moderna . 818 0 obj <> endobj 0000107012 00000 n Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. You may need to read it again. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. 0000001596 00000 n This will help to protect you against COVID-19 in the future. There endstream endobj 780 0 obj <. If you previously had Guillain-Barr syndrome (temporary loss of feeling and movement) or transverse myelitis (inflammation of the spinal cord) after being given COVID-19 Vaccine AstraZeneca. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 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 endstream 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. It will take only 2 minutes to fill in. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX 346 65 Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. 0000100169 00000 n COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). Seek immediate medical attention if you develop these symptoms in the days following vaccination. 0000098749 00000 n Solution for injection. endobj Health information in your inbox, every other week. Some cases had a fatal outcome. brain, liver, bowel, spleen). 5. 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. 11 Apr 2021. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. If you have any further questions, ask your doctor, pharmacist or nurse. 0000003715 00000 n 0000015824 00000 n If you get any side effects, talk to your doctor, pharmacist or nurse. Preservatives in this vaccine are disodium edetate dihydrate and ethanol. Published March 31, 2021 Updated Aug. 1, 2021. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. Six of the 28 died from their clotting complications. 967 0 obj <>stream During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 0000004159 00000 n Wait until any effects of the vaccine have worn off before you drive or use machines. 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. Consumer Information. If you get any side effects, talk to your doctor, pharmacist or nurse. (see section 2. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. . How to store COVID-19 Vaccine AstraZeneca 6. Dont worry we wont send you spam or share your email address with anyone. It is a proven, safe and relatively old approach. Possible side effects 5. 0000012641 00000 n AstraZeneca vs. Sinovac side effects. 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. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 53 0 obj 0 Efficacy. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. 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. 0000009283 00000 n . 0000000016 00000 n 0000054208 00000 n The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. 3.What if I am taking, have recently taken or might take other medicinesor 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. Vaccine Excipient Summary Excipients Included in U.S. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream Discard the vial and do not combine residual vaccine from multiple vials. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. This product contains genetically modified organisms (GMOs). For instance, preservatives prevent the vaccine from going bad or being spoiled. Like all medicines, this vaccine can cause side effects, although not everybody gets them. syndrome [GBS]), rapid swelling under the skin in areas such as the face, lips, mouth and throat (which may cause difficulty in swallowing or breathing) (angioedema), capillary leak syndrome (a condition causing fluid leakage from small blood vessels), very low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, Blood disorders), blood clots in the brain, not associated with low level of blood platelets (see section 2, Blood disorders), inflammation of the spinal cord which may cause muscle weakness, localised or radiating back pain, bladder and bowel symptoms and changes in sensation (transverse myelitis). When autocomplete results are available use up and down arrows to review and enter to select. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 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 . The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. 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. 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. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. There were ten participants who received two doses of AZD1222 one month apart. 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 You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. 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. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Store in a refrigerator (2C to 8C). 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. 0000083589 00000 n 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. 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 final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. During use it can be stored from 2C to 25C. <]/Prev 553136>> Page last updated Thursday, May 26, 2022 0000104331 00000 n }wfydUj_mr\]]s=']O_Od>MdD.PHTpo We comply with the HONcode standard for trustworthy health information. 0000082376 00000 n Dosage level (s) 5 1010 vp (nominal). See section 4. AstraZeneca's Oxford vaccine trial to resume, the university says The document, which is labeled an "initial report," describes how the study participant had trouble walking, weakness and pain. 0000021326 00000 n %PDF-1.7 % Any unused vaccine or waste material should be disposed of in accordance with local requirements. A vaccine is tested on humans, in the UK, Brazil, South Africa and the US 0000003715 n! The US storing this vaccine and disposing of any unused product correctly as new data become available, will... [ recombinant ] ) [ COVID-19 vaccine AstraZeneca ] with other vaccines have not been evaluated waste material should in! 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