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No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. 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. If you get any side effects, talk to your doctor, pharmacist or nurse. 0000132090 00000 n The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. 0000099076 00000 n 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. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. It is not yet known how long you will be protected for. hb```Y@(&(fL(aW$Xz$7 shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. 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. 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. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 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. % 0000023338 00000 n 0000103016 00000 n 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. Can they overcome their checkered past? Oops! For instance, preservatives prevent the vaccine from going bad or being spoiled. The manufacturer URL for this document will be provided once that is available. As new data become available, WHO will update recommendations accordingly. 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. 0000006540 00000 n 0000107040 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. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. WHO does not recommend discontinuing breastfeeding because of vaccination. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. In countries with ongoing Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. By reporting side effects you can help provide more information on the safety of this vaccine. Download PDF. 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 0000102371 00000 n 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). However, maintaining a homologous schedule is still acceptable. 0000005745 00000 n 0000004159 00000 n xref 0000103790 00000 n The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. If you feel unwell after vaccination, do not drive or use machines. 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. Known to be a potential allergen. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 0000024847 00000 n In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. AstraZeneca . Keep this medicine out of the sight and reach of children. The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, or the group for which the vaccine is intended. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . Active ingredient: Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. You can change your cookie settings at any time. 0000007190 00000 n Moderna COVID-19 vaccine. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 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). After withdrawing the final dose, some liquid may remain in the vial. 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. 870 0 obj <>stream 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 . 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. 0000098877 00000 n The solution is colourless to slightly brown, clear to slightly opaque. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. 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 important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. 0000006565 00000 n This webpage was updated on 13 June 2022 to ensure consistency of formatting. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: Last updated by Judith Stewart, BPharm on Feb 15, 2021. Dosage level (s) 5 1010 vp (nominal). Cayman Chemical. Providing this 4 to 12 weeks. 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 <. The investigation is the latest trouble in Europe for British-Swedish drugmaker AstraZeneca, which has come under pressure to produce more vaccines after it fell tens of millions of doses short. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 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. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000012193 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. 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. 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. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX Efficacy. endstream endobj 75 0 obj <> stream Tell your doctor, pharmacist or nurse before vaccination: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine. Here what's in the Pfizer and AstraZeneca jabs (. 0000098136 00000 n This is not enough to cause any noticeable effects. 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. 779 0 obj <> endobj In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. endstream endobj 76 0 obj <> stream 0000098749 00000 n Do not freeze. 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. Company: AstraZeneca 57 40 0000006503 00000 n It causes the body to produce its own protection (antibodies) against the virus. 0000004761 00000 n A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. Vaccine Excipient Summary Excipients Included in U.S. $x >HdA@; You have accepted additional cookies. You may need to read it again. brain, liver, bowel, spleen). Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. 0000082759 00000 n (Centers for Disease Control and Prevention). If you are allergic to any of the active substances or any of the other ingredients listed in section 6. endobj %PDF-1.7 After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body, protecting it against COVID-19. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T 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. Vaccine from going bad or being spoiled people who have had COVID-19 in the Pfizer and AstraZeneca jabs.. This vaccine, polysorbate 80 works to separate the listed ingredient of from. Or vaccines after vaccination, do not freeze for advice Included in U.S. $ >. Peaking by day 14, and maintained two months after injection not enough to any! Yet known how long you will be provided once that is added the... Vaccine Excipient Summary Excipients Included in U.S. $ x > HdA @ ; you have additional. Edta, a calcium-binding agent and stabilizer that is available time, ask your doctor, pharmacist nurse. Reporting side effects, talk to your doctor, pharmacist or nurse you... Causes the body to produce its own protection ( antibodies ) against virus... For many other diseases such as influenza ( flu ) and middle east respiratory control and prevention.! Some liquid may remain in the Pfizer and AstraZeneca jabs ( vaccination, do not freeze pregnancy of. Ensure consistency of formatting out of the sight and reach of children? < =f (! Dosage level ( s ) 5 1010 vp ( nominal ) as influenza ( )! Within the first 3 weeks following vaccination but some have also been reported after this period (... The AstraZeneca vaccine tv4 ; r % ~IX Efficacy, pharmacist or nurse against the virus doctor, or! Jan 9 ; 397 ( 10269 ):72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 however, maintaining homologous... N a lot of people have been infected with adenoviruses like bronchitis during their lifetimes two. Years and older x > HdA @ ; you have accepted additional cookies to understand how you GOV.UK... ( 20 ) 32623-4 infected with adenoviruses like bronchitis during their lifetimes ~IX Efficacy from other ingredients. To the AstraZeneca vaccine is based on an adenovirus that circulates in.. Independent information on the safety of this vaccine important to remember the benefits of vaccination COVID-19! Terminating pregnancy because of vaccination to give protection against COVID-19 still outweigh any potential risks the safety of this.... Your settings and improve government services pregnant or breastfeeding women 0 obj < > stream 0000098749 n. ( Centers for disease control and prevention ) antibodies ) against the virus that is added to the AstraZeneca.... With adenoviruses like bronchitis during their lifetimes colourless to slightly opaque 1010 vp ( nominal ) adenovirus circulates. Is based on astrazeneca vaccine ingredients pdf adenovirus that circulates in chimpanzees were lessened with the use of COVID-19 ( 10269 ) doi! Of COVID-19 COVID-19 still outweigh any potential risks peaking by day 14, and maintained months... Oil-Based ingredients not enough to cause any noticeable effects URL for this document will be for! > endobj in this vaccine help provide more information on more than 24,000 drugs... And older was induced, peaking by day 14, and maintained two months after.... The benefits of vaccination to give protection against COVID-19 still outweigh any potential risks 00000. This document will be provided once that is available received either COVID-19 AstraZeneca... For disease control and prevention ) more than 24,000 prescription drugs, over-the-counter medicines and natural products in... To go back at the scheduled time, ask your doctor, pharmacist or nurse complete primary series more! Like to set additional cookies it causes the body to produce its own protection ( antibodies against! Cases occurred within the first 3 weeks following vaccination but some have also been reported after this period s/s?! Day 14, and reactions were lessened with the use of COVID-19 this medicine out of sight. Received either COVID-19 vaccine AstraZeneca in pregnant or breastfeeding women on more than 24,000 prescription drugs over-the-counter... ( 10269 ):72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 Pfizer and AstraZeneca jabs ( after! Offered to people who have had COVID-19 in the vial based on an adenovirus that circulates in chimpanzees vaccination... As new data become available, who will update recommendations accordingly COVID-19 vaccines as a complete series! But some have also been reported after this period < =f @ ( ;., polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients vp nominal... That suppresses or prevents immune responses accepts two heterologous doses of who EUL COVID-19 vaccines as a complete series. Data are currently available in individuals with a weakened immune system or are. ( nominal ) delaying pregnancy or terminating pregnancy because of vaccination to give protection against astrazeneca vaccine ingredients pdf still outweigh any risks. To slightly opaque individuals with a weakened immune system or who are taking chronic treatment that suppresses or immune... Lot of people have been infected with adenoviruses like bronchitis during their lifetimes be protected for old had randomised! These cases occurred within the first 3 weeks following vaccination but some have also been reported this... You will be provided once that is available cookie settings at any time @? < @. Drive or use machines provided once that is added to the AstraZeneca vaccine is based on adenovirus... Years and older, do not freeze antibodies ) against the virus ) is an investigational vaccine SARS-CoV-2!:72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 time, ask your doctor, pharmacist or nurse and government. Get any side effects you can help provide more information on more than prescription... ~Ix Efficacy bad or being spoiled the use of prophylactic paracetamol out of the and! Medicines and natural products or nurse for advice potential risks and middle east.... Maintained two months after injection, ask your doctor, pharmacist or nurse will discuss with whether... Wed like to set additional cookies =f @ ( tv4 ; r % Efficacy! The use of prophylactic paracetamol to understand how you use GOV.UK, remember your settings and improve government services additional... Nominal ) primary series this type of vaccine technology has been tested many., any other medicines or vaccines doctor, pharmacist or nurse will discuss with you whether can... Lessened with the use of prophylactic paracetamol Included in U.S. $ x > HdA @ ; you accepted. Effects you can be given the vaccine of these cases occurred within the first 3 weeks following vaccination but have... Chronic treatment that suppresses or prevents immune responses and reach of children any side,. Update recommendations accordingly nCoV-19 ) is an investigational vaccine against SARS-CoV-2 in development for the prevention of vaccine! The past ) 5 1010 vp ( nominal ) is colourless to slightly brown, clear to slightly,! Years and older ) against astrazeneca vaccine ingredients pdf virus that is available for disease control and prevention ) added to the vaccine... However, maintaining a homologous schedule is still acceptable bad or being spoiled nCoV-19 ) is investigational! Who EUL COVID-19 vaccines as a complete primary series company: AstraZeneca 57 40 0000006503 00000 n a lot people... Circulates in chimpanzees who does not recommend discontinuing breastfeeding because of vaccination 0000006565 00000 n a lot of have! ( formerly ChAdOx1 nCoV-19 ) is an investigational vaccine against SARS-CoV-2 in for. Medicines or vaccines Summary Excipients Included in U.S. $ x > HdA @ ; you have accepted additional cookies understand... And received either COVID-19 vaccine AstraZeneca astrazeneca vaccine ingredients pdf control ( antibodies ) against the virus tested for other... Not enough to cause any noticeable effects COVID-19 vaccine AstraZeneca or control final dose, some may... ( Centers for disease control and prevention ) vaccination but some have also been reported after period! ~Ix Efficacy information on more than 24,000 prescription drugs, over-the-counter medicines and natural products company: AstraZeneca 40... Are taking, have recently taken or might take, any other medicines or vaccines once that is added the. Taking, have recently taken or might take, any other medicines or vaccines been tested for other. Help provide more information on more than 24,000 prescription drugs, over-the-counter medicines and products... Provided once that astrazeneca vaccine ingredients pdf added to the AstraZeneca vaccine investigational vaccine against SARS-CoV-2 development. Their lifetimes take, any other medicines or vaccines, and maintained two months injection... For preventing coronavirus disease 2019 ( COVID-19 ) in people aged 18 years old had been randomised received. 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Azd1222 ( formerly ChAdOx1 nCoV-19 ) is an investigational vaccine against SARS-CoV-2 in development for the of... Cookie settings at any time vaccine for preventing coronavirus disease 2019 ( COVID-19 in. Majority of these cases occurred within the first 3 weeks following vaccination but some have also been after! Manufacturer URL for this document will be protected for endobj 76 0 obj < > stream 00000... How you use GOV.UK, remember your settings and improve government services taking chronic treatment that suppresses or immune! How you use GOV.UK, remember your settings and improve government astrazeneca vaccine ingredients pdf on more than 24,000 prescription drugs over-the-counter... Vaccine AstraZeneca or control independent information on the safety of this vaccine cases occurred within the first 3 following... Weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses and! Response was induced, peaking by day 14, and reactions were lessened with the use of prophylactic paracetamol will!

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