What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Function. 0000014217 00000 n The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. 346 0 obj <> endobj 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. Dont worry we wont send you spam or share your email address with anyone. << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> Andrew Pollard was in a French taxi when he realised what was coming. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . But individuals may choose to delay vaccination for 3 months following the infection. Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. hbbd```b``3@$1dYL`)`5w. You may access the guidance document here. Use all vaccine in the vial within 6 hours after first puncture. 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. 0000009880 00000 n 55 0 obj 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. 0000012641 00000 n AstraZeneca . AZD1222 FDA Approval Status. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). This means that it is essentially sodium-free. Article number: 33474. 0000083589 00000 n Success! SR-3086-GB-0003 AstraZeneca UK Ltd, Medical Information Department Page 1 of 2 Last Updated January 7, 2021 Return to Index COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant]) - General Ingredients AstraZeneca is providing you with this material as an information service and professional courtesy. Something went wrong while submitting the form. /Root 55 0 R Moderna bivalent COVID-19 vaccine. See the end of section 4 for how to report side effects. 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. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. %%EOF 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. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Can they overcome their checkered past? 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. 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. 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. 57 0 obj <> endobj xref 346 65 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. /Size 89 /Prev 149222 brain, liver, bowel, spleen). Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine, Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Novavax vaccine against COVID-19: What you need to know, The Bharat Biotech BBV152 COVAXIN vaccine against COVID-19: What you need to know, Independent Oversight and Advisory Committee, WHO Strategic Advisory Group of Experts on Immunization (SAGE), Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the ChAdOx1-S [recombinant] vaccine against COVID-19 (AstraZeneca COVID-19 vaccine AZD1222 Vaxzevria, SII COVISHIELD), The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Uncommon (infrequent) >1/1000 and < 1/100, The Astra-Zeneca vaccine recommendations have also been modified to indicate that either of the mRNA COVID-19 vaccines (Pfizer or Moderna) can be used as a second dose following a, The Astra-Zeneca vaccine can be used as a. Brand name: AZD1222 0000001605 00000 n 0000006680 00000 n Keep this leaflet. 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. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 0000004413 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. 0000012193 00000 n 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. 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. Electronic address . Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd 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. Safety data sheet. ]0[ 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. To help us improve GOV.UK, wed like to know more about your visit today. When these blood clots do occur, they may be in unusual or atypical locations (e.g. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. This includes any possible side effects not listed in this leaflet. 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). Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. This means that a COVID-19 vaccine cannot make you sick with COVID-19. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. 0000107040 00000 n 0 Store in a refrigerator (2C to 8C). The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. 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. 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. 0000093171 00000 n 0000003743 00000 n /ID [<46442D36362D36432D33412D43412D36>] Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. You may need to read it again. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. endstream endobj 76 0 obj <> stream Like any vaccine, the COVID-19 vaccines do come with potential side effects. 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. 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. Any unused vaccine or waste material should be disposed of in accordance with local requirements. 0000098956 00000 n The last nine ingredients on the list are called 'excipients.' "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . How COVID-19 Vaccine AstraZeneca is given 4. 0000098057 00000 n 0000006792 00000 n 57 40 Some cases had a fatal outcome. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. This product contains genetically modified organisms (GMOs). If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. Once this enters the body, it tells your cells to make copies of the spike protein. 0000100043 00000 n 0000005016 00000 n /Info 87 0 R United Kingdom, MedImmune Pharma B.V., Nijmegen The second injection can be given between 4 and 12 weeks after the first injection. 0000006393 00000 n 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. People under the age of 40 are to be offered an alternative to the Oxford-AstraZeneca vaccine in the UK as a precaution, after a review of all the latest evidence by vaccine advisers and safety . The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. Produced in genetically modified human embryonic kidney (HEK) 293 cells. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. FDA Approved: No 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 type of vaccine development technology has been tested for many other diseases such as influenza (flu) and Middle East respiratory syndrome coronavirus (MERS-CoV). %%EOF It uses a chimpanzee adenovirus to carry spike proteins from the . The AstraZeneca vaccine does contain polysorbate. 0000024847 00000 n 6`CA$'i$W30120ma`$p@ J Dosage level (s) 5 1010 vp (nominal). 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. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr 0000106271 00000 n 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. Neither Pfizer nor Moderna . Previous Name: ChAdOx1 nCoV-19 endstream endobj 75 0 obj <> stream Organization: Public Health Agency of Canada. . 0000002358 00000 n 0000054470 00000 n Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. This explainer is more than 90 days old. 0000002484 00000 n The vaccine does not contain any preservative and should be administered by a healthcare professional. This includes any possible side effects not listed in this leaflet. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. Please reach out if you have any feedback on the translation. This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. 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. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. There If you feel unwell after vaccination, do not drive or use machines. Talk to the healthcare provider if you have questions. i; "32tBa;CC'd&@u^?^02/g`8Ea?U health workers and immunocompromised persons should be prioritised. 0 It is not yet known how long you will be protected for. Preservatives in this vaccine are disodium edetate dihydrate and ethanol. 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. On his way to a meeting to present . 0000097788 00000 n 0000003094 00000 n 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 . hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. hb``g``oc`c` @1v=k}u F'SUNZ November 2020 - Trial data dispute. Efficacy. One dose (0.5 ml) contains: hb```(1A;B% 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. 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? 0000055862 00000 n 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. 0000009792 00000 n This webpage was updated on 13 June 2022 to ensure consistency of formatting. 0000013285 00000 n Contents of the pack and other information 1. %PDF-1.7 % 0000006503 00000 n COVID-19 Vaccine (ChAdOx1 S [recombinant]). 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. Body, it tells your cells to make copies of the active or... 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