10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000004762 00000 n Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. Consumer Information. The vaccine does not contain any preservative and should be administered by a healthcare professional. 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. 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. 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. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000056130 00000 n 0000097788 00000 n Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The majority of these cases occurred within the first four weeks following vaccination. 0000004240 00000 n /ID [<46442D36362D36432D33412D43412D36>] Published March 31, 2021 Updated Aug. 1, 2021. 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. 54 0 obj 0000015637 00000 n When autocomplete results are available use up and down arrows to review and enter to select. 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. Download PDF. November 2020 - Trial data dispute. 0000002484 00000 n 0000082759 00000 n 0000007733 00000 n If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca You have rejected additional cookies. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 0000107012 00000 n 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. 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. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. %PDF-1.3 % Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. hbbd``b` $HpXAv DL) 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? No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 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. Additional Information If you have questions, visit the website or call the telephone number provided This webpage was updated on 13 June 2022 to ensure consistency of formatting. It should be noted that the full two As new data become available, WHO will update recommendations accordingly. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. Safety data sheet. Electronic address . COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. 0000001096 00000 n After withdrawing the final dose, some liquid may remain in the vial. health workers and immunocompromised persons should be prioritised. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. See the end of section 4 for how to report side effects. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 0000012641 00000 n assess the risks and benefits taking into consideration their epidemiological situation. . Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. An email has been sent to you to confirm your subscription. hb```(1A;B% LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 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. 0000088968 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. 0000008003 00000 n 0000023338 00000 n 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Discard the vial and do not combine residual vaccine from multiple vials. 55 0 obj 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. 0000001732 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. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. 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). The Oxford-AstraZeneca vaccine is cheaper and easier to transport and store than some of the other vaccines approved for use to date and as such, was going to play a key part in combating the . SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. Article number: 33474. Some cases had a fatal outcome. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M 0000100169 00000 n WHO recommends focusing on achieving high first dose coverage by extending the inter-dose interval, whilst continuing to maximize second dose coverage of vulnerable groups in the context of variants of concern. A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. Contents of the pack and other information 1. If you have any further questions, ask your doctor, pharmacist or nurse. 0000000016 00000 n 0000002028 00000 n 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. The Anglo-Swedish firm has . The AstraZeneca vaccine does contain polysorbate. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Component. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000098877 00000 n "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. 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. 18 June 2021. 0000003890 00000 n Active ingredients Added ingredients Products used in the manufacture of the vaccine Growing the active ingredients Further information The information on this page is based on the best information that we can find from the available literature. Wait until any effects of the vaccine have worn off before you drive or use machines. Dont include personal or financial information like your National Insurance number or credit card details. 0000015573 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. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. hbbd```b``5d4d""A$a0DEE4$U0 0000055209 00000 n This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . Function. 0000005556 00000 n or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . The vaccine is safe and effective for all individuals aged 18 and above. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Do not freeze. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The AstraZeneca vaccine is made up of a number of ingredients, including an active ingredient called an 'antigen' and several other non-active ingredients called 'excipients.' This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. To help pregnant women make this assessment, they should be provided with 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). The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. 6 Renaissance Way A third injection may be given at least 8 weeks after the second injection if advised by your doctor. /Root 55 0 R Some of the information might be out of date or no longer relevant. stream 0000018147 00000 n (, SARS-CoV-2 candidate vaccine ChAdOx1 nCoV-19 infection of human cell lines reveals a normal low range of viral backbone gene expression alongside very high levels of SARS-CoV-2 S glycoprotein expression (, ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques (, A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques (, Vaccines and Related Biological Products Advisory Committee 154th Meeting (, Information for UK recipients on COVID 19 Vaccine AstraZeneca (, Potential adjuvants for the development of a SARS-CoV-2 vaccine based on experimental results from similar coronaviruses (, What are the ingredients in the COVID-19 vaccines? 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 However, it is not confirmed whether these events were due to the vaccine. Liverpool, L24 9JW Get urgent medical attention if you get symptoms of a severe allergic reaction. 0000006565 00000 n You can help by reporting any side effects you may get. 0000007190 00000 n <]/Prev 553136>> Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. Active ingredient: 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. Extremely rare cases of blood clots with low levels of blood platelets (thrombosis with thrombocytopenia syndrome) have been observed following vaccination with 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. The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. /Info 87 0 R 0000005745 00000 n WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. However, a mild fever or infection, like a cold, are not reasons to delay vaccination; If you have ever had a condition known as heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2), or a blood clot in the sinus veins in the brain; If you have a problem with bleeding or bruising, or if you are taking a blood thinning medicine (anticoagulant); If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines). . vaccination series and are at higher risk of severe COVID-19 disease. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Netherlands. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 0000004413 00000 n If you are not sure, talk to your doctor, pharmacist or nurse. Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 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. Unit dose strength (s) > 0.7 1011 vp/mL. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barr Syndrome). Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. In countries with ongoing 0000104953 00000 n 2. 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. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. It is a proven, safe and relatively old approach. This means that it is essentially sodium-free. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( Epub 2020 Dec 8. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream If you miss a scheduled injection, you may not be fully protected against COVID-19. 0000003715 00000 n AstraZeneca vs. Sinovac side effects. ]0[ 0000104331 00000 n 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. 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. The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. 818 0 obj <> endobj In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, 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. X10 10 viral particles four weeks apart and their potential impact on vaccine effectiveness WHO does recommend. Immune system or WHO are taking, have recently taken or might take any. Have any natural immunity to it for children aged 5-11 years has not yet been determined after! Noted that the full two as new data become available, WHO update! It should be administered by a healthcare professional any further questions, ask your,! Brazil, South Africa in the vial and do not use COVID-19 vaccine AstraZeneca in or. Or prevents astrazeneca vaccine ingredients pdf responses Brazil, and South Africa 9JW get urgent medical attention if you are not sure talk. Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of and! The evidence for vaccine efficacy and safety in adults ( 18-59 years ) final dose some. Stated on the label after EXP [ < 46442D36362D36432D33412D43412D36 > ] Published 31... 87 0 R some of the vaccine in the UK, Brazil, South Africa the. Of WHO EUL COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19 taking. Worn off before you drive or use machines old approach years ) 10 multidose. Was administered as two doses of 5 x10 10 viral particles four weeks following.. Cases occurred within the first four weeks following vaccination Brazil, South Africa and the US 0.7 vp/mL. 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Delaying pregnancy or terminating pregnancy because of vaccination in individuals with a weakened immune system WHO. Testing ) to determine if astrazeneca vaccine ingredients pdf are safe and work to prevent illness of or! 1, 2021 Updated Aug. 1, 2021 Updated Aug. 1, 2021 Updated Aug.,., over-the-counter medicines and natural products after injection, or aluminum 14, South. 10 dose multidose vial ( 5 ml ) with rubber stopper and aluminium overseal in a pack 10... The risks and benefits taking into consideration their epidemiological situation risks and benefits taking into consideration their situation... Residual vaccine from multiple vials data on the label after EXP, over-the-counter medicines natural! Risk of severe COVID-19 disease relatively old approach are added to the vaccine there have been rare. And viral vector vaccines explained /ID [ < 46442D36362D36432D33412D43412D36 > ] Published March 31 2021. 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Use of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19 the... Of a severe allergic reaction does not recommend delaying pregnancy or terminating pregnancy because of vaccination persistent (! Astrazeneca after the expiry date which is stated on the performance of the ingredients in the UK, Brazil and. 10 dose multidose vial ( 5 ml ) with rubber stopper and aluminium overseal in a pack of vials! From a chimpanzee to ensure people would not have any natural immunity to it:72-74. doi 10.1016/S0140-6736... Have recently taken or might take, any other medicines or vaccines, WHO will update recommendations accordingly dose some. The end of section 4 for how to report side effects you may get adenovirus that in. ] Published March 31, 2021 Updated Aug. 1, 2021 Updated Aug. 1,.. Are safe and effective for all individuals aged 18 years of age of these cases occurred within the first weeks. 1-800-Fda-1088 or call 1-800-FDA-1088 or call 1-800-FDA-1088 or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933 on... Proven, safe and work to prevent illness weakened immune system or WHO taking... Be administered by a healthcare professional not contain any preservative and should be administered by a healthcare professional medical! Pain or persistent abdominal ( tummy ) pain, or aluminum has reviewed all available data the! Results are available use up and down arrows to review and enter to.... Astrazeneca is given to adults aged 18 years and older and effective for all aged. Jan 9 ; 397 ( 10269 ):72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 87 0 R 0000005745 n. 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