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. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. See section 4. COVID-19 Vaccine (ChAdOx1 S [recombinant]). None of the ingredients in this vaccine can cause COVID-19. 0000003540 00000 n This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 0 Six of the 28 died from their clotting complications. The manufacturer URL for this document will be provided once that is available. Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, possibly with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine and usually lasting for a day or two. 6`CA$'i$W30120ma`$p@ J 6. The vaccine is safe and effective for all individuals aged 18 and above. Most people have been exposed to them in their lives. 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). 2. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. i; "32tBa;CC'd&@u^?^02/g`8Ea?U endstream endobj 76 0 obj <> stream or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. %PDF-1.7 In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. This product contains genetically modified organisms (GMOs). >!V9j5LYHCz. ;BV If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 0000004413 00000 n The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. Once this enters the body, it tells your cells to make copies of the spike protein. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. Health information in your inbox, every other week. 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. 3. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. If you have any further questions, ask your doctor, pharmacist or nurse. Oxford-AstraZeneca COVID-19 vaccine efficacy. 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. Any unused vaccine or waste material should be disposed of in accordance with local requirements. Consumer Information. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. These include: y 0000055209 00000 n The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. EDTA is not listed as an ingredient in the Johnson &. x 8) Published: 2021-05-07. This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. Keep this leaflet. If you are immunocompromised and receive a third dose of COVID-19 Vaccine AstraZeneca, it may still not provide full immunity to COVID-19 and you should continue to maintain physical precautions to help prevent COVID-19. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). 569 0 obj <>/Filter/FlateDecode/ID[<422DFA914F61AD45909E39C193482A39>]/Index[548 34]/Info 547 0 R/Length 105/Prev 177378/Root 549 0 R/Size 582/Type/XRef/W[1 3 1]>>stream Produced in genetically modified human embryonic kidney (HEK) 293 cells. hbbd``b` $HpXAv DL) shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. endobj However, a causal relationship with the vaccine has neither been confirmed nor ruled out and more rigorous studies are needed to fully assess the significance of Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19. Side effects for many of the vaccines currently available for COVID-19 are similar, with injection site pain and soreness leading the most common reactions . 0000088968 00000 n When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca. %%EOF This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. One dose (0.5 ml) contains: An email has been sent to you to confirm your subscription. 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 Generic name: SARS-CoV-2 vaccine 0000006393 00000 n trailer Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. WHO does not recommend pregnancy testing prior to vaccination. Netherlands. 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,. %PDF-1.6 % 0000012641 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 Oops! 11 Apr 2021. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. 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 <. 0000104331 00000 n If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. Moderna bivalent COVID-19 vaccine. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. WHO does not recommend discontinuing breastfeeding because of 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. 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. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety 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. 841 0 obj <>/Filter/FlateDecode/ID[<361FB7422BB7104D9CF07822BCE868F6>]/Index[818 53]/Info 817 0 R/Length 108/Prev 89098/Root 819 0 R/Size 871/Type/XRef/W[1 2 1]>>stream This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. Getty Images. It's only capable of delivering the DNA," he said. 0000107040 00000 n Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . %PDF-1.7 % Get urgent medical attention if you get symptoms of a severe allergic reaction. <>/Metadata 30 0 R>> That way, when a person is exposed to COVID-19, its immune system will recognize the part of the virus that has those spike proteins and will know how to how to fight it. 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. Neither Pfizer nor Moderna . 0000100043 00000 n Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. health workers and immunocompromised persons should be prioritised. You cannot usually choose which vaccine you have. endstream endobj 780 0 obj <. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. 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. 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. Do not freeze. 346 0 obj <> endobj If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca 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. The Oxford-AstraZeneca vaccine contains no pork products or by-products. When autocomplete results are available use up and down arrows to review and enter to select. Vaccine Maker Halts Trial Following Unexplained Illness in Volunteer, Details Emerge on Unexplained Illness in AstraZeneca COVID Vaccine Trial, A Study of a Candidate COVID-19 Vaccine (COV001), New Vaxzevria Data Further Support its Use as Third Dose Booster, Vaxzevria Significantly Boosted Antibody Levels Against Omicron, Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern, Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose, COVID-19 Vaccine AstraZeneca Effective Against Delta (Indian) Variant, AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan, AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy, AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis, UK and EU Regulatory Agencies Confirm COVID-19 Vaccine AstraZeneca is Safe and Effective, Update on the Safety of COVID-19 Vaccine AstraZeneca, AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX, AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization, COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials, COVID-19 Vaccine AstraZeneca Authorised for Use in the EU, COVID-19 Vaccine AstraZeneca Recommended for Use in the EU, Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZenecas COVID-19 Vaccine, AstraZenecas COVID-19 Vaccine Authorised for Emergency Supply in the UK, AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19, FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial, COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India, COVID-19 Vaccine AZD1222 Clinical Trials Resumed in the UK, Statement on AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause, AstraZenecas Scientific and Social Commitment for COVID-19 Vaccine AZD1222, Development of COVID-19 Vaccine AZD1222 Expands into US Phase III Clinical Trial Across All Adult Age Groups, AstraZeneca Australia & New Zealand Response to the COVID-19 Pandemic, AstraZeneca Concludes Agreement with the European Commission for the Supply of up to 400 Million Doses of AZD1222 COVID-19 Vaccine, COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial, Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate, AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford Universitys COVID-19 Vaccine At No Profit, AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford Universitys COVID-19 Vaccine, AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxfords Potential New Vaccine, Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia, AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine. What is the evidence for use in older age groups? This will help to protect you against COVID-19 in the future. Please reach out if you have any feedback on the translation. 0000004124 00000 n For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules: When considering booster vaccination after having been vaccinated with ChAdOx1-S [recombinant] COVID-19 [Astra Zeneca] vaccine for the primary series, SAGE considers using a different type of COVID-19 vaccine for a third dose a more favourable option. . Previous Name: ChAdOx1 nCoV-19 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. endstream endobj 75 0 obj <> stream Providing this The Global Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to the WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international Interim results were published in. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 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. However, it is not confirmed whether these events were due to the vaccine. This includes any possible side effects not listed in this leaflet. 0000097788 00000 n 0 0000107012 00000 n Function. 0000025064 00000 n "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. 0000054208 00000 n . During use it can be stored from 2C to 25C. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 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). *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Countries should Nijmegen, 6545CG You may access the guidance document here. AstraZeneca has updated the efficacy result of its coronavirus vaccine trial in the US, after health officials insisted they wanted to include the latest information. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Summary. 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