Read all of this leaflet carefully before the vaccine is given because it contains important information for you. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. Efficacy. %PDF-1.3 % This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr 0000085176 00000 n 0000004240 00000 n No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. By reporting side effects you can help provide more information on the safety of this vaccine. xcbd```b``A$c0{.fH "uAY@1bFg210MW endstream endobj 76 0 obj <> stream dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w 967 0 obj <>stream 0000102371 00000 n 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. Some of the information might be out of date or no longer relevant. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. When these blood clots do occur, they may be in unusual or atypical locations (e.g. . 0000104953 00000 n 0 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 0000008003 00000 n 0000011249 00000 n Spills should be disinfected using agents with activity against adenovirus. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Something went wrong while submitting the form. In the meantime, we must maintain and strengthen public health and social measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . %PDF-1.7 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. , ,p During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. Liverpool, L24 9JW The manufacturer URL for this document will be provided once that is available. endstream endobj 75 0 obj <> stream endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream 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. We comply with the HONcode standard for trustworthy health information. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. Page last updated Thursday, May 26, 2022 346 0 obj <> endobj are no data yet for Omicron. %PDF-1.7 % Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. It is designed for consumers and care givers. endstream endobj 780 0 obj <. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . /ID [<46442D36362D36432D33412D43412D36>] LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 2. 0000015824 00000 n Organization: Public Health Agency of Canada. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. 0000025064 00000 n This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- 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. << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> Treatment for: Prevention of COVID-19. The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male. 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. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. Use all vaccine in the vial within 6 hours after first puncture. 0000004159 00000 n With Australia's COVID vaccine rollout slowly getting underway, what's inside the Pfizer and Astrazeneca jabs is the question now front and centre for a growing number of people hesitant about getting the vaccination.. Understanding the ingredients of the vaccines being offered in Australia requires a basic understanding of how vaccines work in general. 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). 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. 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? 0000019840 00000 n 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. If you miss a scheduled injection, you may not be fully protected against COVID-19. 779 0 obj <> endobj Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome (TTS), involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. 0000012193 00000 n The Anglo-Swedish firm has . COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In . Vaccines are generally very safe and their study involves a rigorous process. AstraZeneca . 818 0 obj <> endobj It has been adjusted to work as a delivery system for the vaccine. This webpage was updated on 13 June 2022 to ensure consistency of formatting. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). 0000008310 00000 n For instance, preservatives prevent the vaccine from going bad or being spoiled. {zzZ`ntK?D6r|D#T$* TGBKz. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. Published: 2021-05-07. If you get any side effects, talk to your doctor, pharmacist or nurse. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 870 0 obj <>stream An email has been sent to you to confirm your subscription. FDA Approved: No It's only capable of delivering the DNA," he said. 0000097826 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. 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. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. k [ 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000082376 00000 n endstream endobj startxref Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Once approved, the drugmaker will work with national governments and international health organizations to monitor vaccine recipients for potential side effects from the vaccine that were not seen in clinical trials (this is called surveillance). 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. 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. This includes any possible side effects not listed in this leaflet. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 0000102152 00000 n 0 It can be life-threatening; If you have ever fainted following any needle injection; If you currently have a severe infection with a high temperature (over 38C). 0000004065 00000 n 5. 0000053643 00000 n Electronic address . In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. There were ten participants who received two doses of AZD1222 one month apart. Article number: 33474. 57 0 obj <> endobj xref COVID-19 Vaccine AstraZeneca contains sodium and alcohol). To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000083589 00000 n 0000055209 00000 n 0000055862 00000 n 581 0 obj <>stream This includes any possible side effects not listed in this leaflet. When autocomplete results are available use up and down arrows to review and enter to select. 0000088968 00000 n hb```(1A;B% Published March 31, 2021 Updated Aug. 1, 2021. %PDF-1.6 % 0000100043 00000 n A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. 4 to 12 weeks. 0000006792 00000 n 346 65 0000132090 00000 n 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. 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