0000093244 00000 n 55 0 obj If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 0000007733 00000 n 3. 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. Here what's in the Pfizer and AstraZeneca jabs (. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream There 0000004413 00000 n It is your choice to receive the COVISHIELD . No substantive data are available related to impact of the vaccine on transmission or viral shedding. 779 0 obj <> endobj 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. 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. , ,p 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. 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. What COVID-19 Vaccine AstraZeneca is and what it is used for COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2). Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. endstream endobj 76 0 obj <> stream Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 0000011249 00000 n hbbd```b``5d4d""A$a0DEE4$U0 Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. 0000107040 00000 n b t@f&!+:eez8YY8.j 7 SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 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. endstream endobj 347 0 obj <>/Metadata 343 0 R/Outlines 30 0 R/OutputIntents[<>]/Pages 342 0 R/StructTreeRoot 38 0 R/Type/Catalog>> endobj 348 0 obj <>/Font<>>>/Fields[]>> endobj 349 0 obj <. %PDF-1.7 % The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. i; "32tBa;CC'd&@u^?^02/g`8Ea?U 0000001596 00000 n Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. We use some essential cookies to make this website work. To help us improve GOV.UK, wed like to know more about your visit today. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 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. 0000009880 00000 n 0000005016 00000 n This includes any possible side effects not listed in this leaflet. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream 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. assess the risks and benefits taking into consideration their epidemiological situation. The vaccine does not contain any preservative and should be administered by a healthcare professional. 4 to 12 weeks. 6 Renaissance Way You can change your cookie settings at any time. Solution for injection. endstream endobj 780 0 obj <. Andrew Pollard was in a French taxi when he realised what was coming. Browse our homepage for up to date content or request information about a specific topic from our team of scientists. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. In . Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . Spills should be disinfected using agents with activity against adenovirus. 0000002028 00000 n It is designed for consumers and care givers. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. Some cases were life-threatening or had a fatal outcome. 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. Function. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . 0000004761 00000 n 0000005745 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. Like all medicines, this vaccine can cause side effects, although not everybody gets them. 0000082376 00000 n AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. Liverpool, L24 9JW on AstraZeneca COVID-19 vaccine for reports of very rare side effects. However, it is not confirmed whether these events were due to the vaccine. <]/Prev 553136>> The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid If you get any side effects, talk to your doctor, pharmacist or nurse. 0000006680 00000 n SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. M Ms CZHto ) 6. 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. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 18 June 2021. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000008310 00000 n The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. 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. 0000097826 00000 n endstream endobj startxref Interim results were published in. 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 first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. 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. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. November 2020 - Trial data dispute. 0000132090 00000 n Please reach out if you have any feedback on the translation. %%EOF 0000002960 00000 n endobj "It can't give you an infection. 0000006540 00000 n 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. But individuals may choose to delay vaccination for 3 months following the infection. O'`` r/ RV"Lj~=n%8w?C * To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. It will take only 2 minutes to fill in. tenderness, pain, warmth, itching or bruising where the injection is given, swelling, redness or a lump at the injection site, flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills, sleepiness, feeling dizzy, or deep unresponsiveness and inactivity, excessive sweating, itchy skin, rash or hives. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 0000106271 00000 n Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 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? COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). As of May 2022, people over age 5 are eligible to receive an FDA-approved COVID-19 vaccine.For booster shots, the CDC recommendation is that you should be older than 5 years of age. AstraZeneca . If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 0000098956 00000 n When these blood clots do occur, they may be in unusual or atypical locations (e.g. 0000003743 00000 n 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). 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. ]0[ Keep this leaflet. 0000006393 00000 n 0000003223 00000 n What is the evidence for vaccine efficacy and safety in adults (18-59 years)? 0000055862 00000 n 0000083589 00000 n This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. Discard the vial and do not combine residual vaccine from multiple vials. You may access the guidance document here. 0000012641 00000 n 0000107188 00000 n 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. 0000002358 00000 n 0000006565 00000 n Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Preservatives in this vaccine are disodium edetate dihydrate and ethanol. up to 16 weeks can be considered. 0000014217 00000 n 3. 0000104953 00000 n The average age of those who have experienced severe allergic reactions so far is . 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