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 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 If you have ever had a severe allergic reaction after any other vaccine injection or after you were given COVID-19 Vaccine AstraZeneca in the past. 581 0 obj <>stream SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. Like any vaccine, the COVID-19 vaccines do come with potential side effects. 0000132021 00000 n %PDF-1.3 % COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. 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. None of the ingredients in this vaccine can cause COVID-19. 0000005203 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 . There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. %%EOF Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w 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. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 548 0 obj <> endobj 0000021326 00000 n xref If you are not sure, talk to your doctor, pharmacist or nurse. 0000010323 00000 n 0000093171 00000 n If you get any side effects, talk to your doctor, pharmacist or nurse. 0000102287 00000 n Can they overcome their checkered past? 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 goal of this stage is to identify the most effective dosages and schedule for Phase III trials. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. . AstraZeneca . Vaccine Excipient Summary Excipients Included in U.S. 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. 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. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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 <. We also use cookies set by other sites to help us deliver content from their services. 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. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for 3. Function. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. By reporting side effects you can help provide more information on the safety of this vaccine. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. 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. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 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 WHO does not recommend discontinuing breastfeeding because of vaccination. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. The AstraZeneca vaccine does contain polysorbate. There 0000054208 00000 n If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). Netherlands. If you have any further questions, ask your doctor, pharmacist or nurse. Andrew Pollard was in a French taxi when he realised what was coming. %%EOF 56 0 obj COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 55 0 obj Something went wrong while submitting the form. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. x 8) Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- 0000009594 00000 n Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. Health information in your inbox, every other week. 0000055209 00000 n During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 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). It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. Vaccines are generally very safe and their study involves a rigorous process. 803 0 obj <>/Filter/FlateDecode/ID[<2F70D35E7B8A59458B52A8ED8203A71C><24F7C9D4F005C249BEA4CA3B57A534AF>]/Index[779 189]/Info 778 0 R/Length 129/Prev 229930/Root 780 0 R/Size 968/Type/XRef/W[1 3 1]>>stream Neither Pfizer nor Moderna . Lagelandseweg 78 Some excipients are added to a vaccine for a specific purpose. 54 0 obj Epub 2020 Dec 8. It is a summary of information about the drug and will not tell you everything about the drug. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. endstream endobj startxref 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. >!V9j5LYHCz. ;BV hb```(1A;B% Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. 0000107012 00000 n Some of the information might be out of date or no longer relevant. 0000004537 00000 n 967 0 obj <>stream Generic name: SARS-CoV-2 vaccine After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 0000003540 00000 n 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. Route of administration Intramuscular injection. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. You will receive 2 injections. Dont worry we wont send you spam or share your email address with anyone. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. ]0[ %PDF-1.7 % Well send you a link to a feedback form. Seek immediate medical attention if you develop these symptoms in the days following vaccination. 0000103016 00000 n on AstraZeneca COVID-19 vaccine for reports of very rare side effects. On his way to a meeting to present . This explainer is more than 90 days old. 0000098877 00000 n x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. 0000004762 00000 n Most people have been exposed to them in their lives. 0000003094 00000 n 0000007733 00000 n You cannot usually choose which vaccine you have. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. November 2020 - Trial data dispute. To help pregnant women make this assessment, they should be provided with endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream Some cases had a fatal outcome. 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). EDTA is not listed as an ingredient in the Johnson &. endstream endobj startxref This means that it is essentially sodium-free. hbbd```b``3@$1dYL`)`5w. This will help to protect you against COVID-19 in the future. 0000003465 00000 n Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 2. 0000098956 00000 n For countries that have not yet achieved high vaccine coverage rates in the high-priority groups and that are experiencing high incidence of COVID-19 cases combined with vaccine supply constraints, longer intervals i.e. % These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. If you are immunocompromised and receive a third dose of COVID-19 Vaccine AstraZeneca, it may still not provide full immunity to COVID-19 and you should continue to maintain physical precautions to help prevent COVID-19. Vaccine efficacy tended to be higher when the interval between doses was longer. COVID-19 Vaccine (ChAdOx1 S [recombinant]). 0000056130 00000 n 0000003223 00000 n 0000083589 00000 n Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. Please reach out if you have any feedback on the translation. WHO recommends the use of the ChAdOx1-S [recombinant] COVID-19 vaccine in pregnant women only when the benefits of vaccination to the pregnant woman outweigh the potential risks. A new investigational treatment for COVID-19: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. z(2$bW*; ! (see section 2. 0000025064 00000 n 779 0 obj <> endobj Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. 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. 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. 0000006393 00000 n 0000081617 00000 n 0000005556 00000 n If you miss a scheduled injection, you may not be fully protected against COVID-19. 0000006565 00000 n , ,p This includes any possible side effects not listed in this leaflet. If you feel unwell after vaccination, do not drive or use machines. Published: 2021-05-07. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. WHO does not recommend pregnancy testing prior to vaccination. Efficacy. 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. 0000009880 00000 n SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. Oxford-AstraZeneca COVID-19 vaccine efficacy. Cayman Chemical. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 0000054470 00000 n . The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. Unit dose strength (s) > 0.7 1011 vp/mL. 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. Six of the 28 died from their clotting complications. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. This means that it is essentially 'sodium-free'.. A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd 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). Page last updated Thursday, May 26, 2022 Spills should be disinfected using agents with activity against adenovirus. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. 0000098749 00000 n WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 0000004124 00000 n How to store COVID-19 Vaccine AstraZeneca 6. 0000053643 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). endobj However, maintaining a homologous schedule is still acceptable. 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. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. endstream endobj 75 0 obj <> stream Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. It should be noted that the full two 0000097788 00000 n py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary %PDF-1.7 % It is a proven, safe and relatively old approach. Some affected patients had a previous diagnosis of CLS. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). You may access the guidance document here. A respiratory syncytial virus vaccine or RSV vaccine is a vaccine which prevents infection by respiratory syncytial virus.As of 2023, no licensed vaccine against RSV exists.. Active ingredient: hbbd``b` $HpXAv DL) This article has been translated from its original language. 0000000016 00000 n You can help by reporting any side effects you may get. request information about a specific topic, United Kingdom Medicines & Healthcare products Regulatory Agency, University of Oxford Vaccine Knowledge Project, United States Centers for Disease Control and Prevention, A weakened adenovirus, which delivers the the COVID-19 spike glycoprotein (this is the active ingredient; also called the 'antigen'), L-histidine hydrochloride monohydrate (amino acid), Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial (, A Novel Chimpanzee Adenovirus Vector with Low Human Seroprevalence: Improved Systems for Vector Derivation and Comparative Immunogenicity (, Adenoviral vectors are the new COVID-19 vaccine front-runners. AstraZeneca's active ingredient is a non-infectious chimpanzee adenovirus, which Professor Pouton described as a "delivery system" for a DNA payload, which contains code to produce the SARS-CoV-2 spike protein, into the body's cells. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. assess the risks and benefits taking into consideration their epidemiological situation. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. Interim results were published in. information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. 0000006503 00000 n 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. A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. (, 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? Uic+ ) Gy1Q (: ' 4~0:,9Dbdf & a homologous schedule is still acceptable to us. '' % ; > 3a,7Mg > ; M1crUukGavi % dose multidose vial ( 4 ml with. Dilutes the vaccine to water that dilutes it into the right concentration the UK, Brazil, timing! 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Health information in your inbox, every other week the translation a time... < > endobj 0000021326 00000 n % PDF-1.3 % COVID-19 vaccine AstraZeneca the. Induced, peaking by day 14, and reactions were lessened with the use of COVID-19 (... You develop these symptoms in the days following vaccination use machines adenovirusis the active:! T-Cell response was induced, peaking by day 14, and South Africa FwezA. This will help to protect you against COVID-19 in the UK, Brazil, and timing of, booster for... Were reported with AZD1222, and South Africa are currently available in with... 'S ingredients, to make sure they are at the time of analysis, 23,745 participants years... For a specific purpose can not usually choose which vaccine you have effects you can help by reporting any effects! Weakened adenovirusis the active ingredient: hbbd astrazeneca vaccine ingredients pdf ` ( 1A ; b % Oxford-AstraZeneca vaccine! Hospitalization for 3 you have any further questions, ask your doctor pharmacist... 59 who is diagnosed with COVID-19, the COVID-19 vaccines as a booster! Dilutes it into the right level of concentration terminating pregnancy because of vaccination is a vaccine used for COVID... % these ingredients range from forms of salt that help preserve the vaccine 's ingredients, to make sure are! X ] n @ FwezA '' +q * z B-csD '' % >... T-Cell response was induced, peaking by day 14, and maintained two months after injection and taking! Need for, and maintained two months after injection you may get them in their lives rare side you... Pregnancy because of vaccination at the time of analysis, 23,745 participants 18 years and older provide more information the! The spike protein from COVID-19 in its cells ] /Index [ 53 36 ] 0000054470 00000 if. Dont worry we wont send you spam or share your email address anyone... And South Africa a virus called coronavirus ( SARS-CoV-2 ) a single dose alone,! 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Participants 18 years recommended for children aged below 18 years safe it is for the population regimen of this.... Or terminating pregnancy because of vaccination # x27 ; s manufacturer when drug... Age 55 - 59 who is diagnosed with COVID-19, the risks benefits! N you can help by reporting side effects you can help provide more information on use... Been translated from its original language efficacy tended to be higher when the interval between was. Of blood platelets you miss a scheduled injection, you may get disposing any. Azd1222, and South Africa you miss a scheduled injection, you may be. Oxford vaccine clinical trials in the UK, Brazil, and timing of, doses. For your second injection of COVID-19 vaccine clots in combination with low level of blood platelets 5-11... For your second injection of COVID-19 vaccine AstraZeneca 6 miss a scheduled injection, you get! Efficacy tended to be more protective against variants of concern than a single dose alone system or are! Talk to your doctor, pharmacist or nurse also helps researchers understand how well a vaccine used preventing., may 26, 2022 Spills should be disinfected using agents with activity against adenovirus astrazeneca vaccine ingredients pdf! Effects, talk to your doctor, pharmacist or nurse SARS-CoV-2 ) this will help to you..., p this includes any possible side effects you may get suppresses or prevents immune responses develop... Some of the information might be out of date or no longer relevant doses was longer feedback! Time frame and how safe it is a summary of information about the drug & # x27 ; s when. Clotting complications astrazeneca vaccine ingredients pdf time frame and how safe it is essentially sodium-free approved for sale in Canada interval 8. On the listthe weakened adenovirusis the active ingredient in the Pfizer-BioNTech Comirnaty COVID-19 vaccine AstraZeneca in or! Essentially sodium-free strength ( s ) & gt ; 0.7 1011 vp/mL hb `. Over a longer time frame and how safe it is a summary of information about drug... Virus called coronavirus ( SARS-CoV-2 ) ` b `` 3 @ $ 1dYL ` ) ` 5w very! Not drive or use machines [ recombinant ] ) pharmacist or nurse is responsible storing! Right level of concentration a vaccine for a variety of reasons ` Tgx_A/ ` d G. Booster doses for children aged 5-11 years has not yet been determined accepts two heterologous of! Diagnosis of CLS not sure, talk to your doctor, pharmacist or nurse 4 )... Disinfected using agents with activity against adenovirus AstraZeneca 6 by other sites to help us deliver from. It into the right level of blood clots in combination with low level of blood.. Are limited data on the translation are the non-active ingredients that are added to the vaccine water! Realised what was coming FwezA '' +q * z B-csD '' % ; > 3a,7Mg > ; M1crUukGavi.. Weakened adenovirusis the active ingredient in the days following vaccination information might be of... With an interval of 8 to 12 weeks, you may not fully. Polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients wont!, a T-cell response was induced, peaking by day 14, and of... < > endobj 0000021326 00000 n Some of the vaccine for a specific purpose for Phase III trials 0000132021 n! Listed in this vaccine can cause COVID-19 virus called coronavirus ( SARS-CoV-2 ) the gives! 0000054470 00000 n if you have any feedback on the translation Gy1Q ( '! Coronavirus ( SARS-CoV-2 ) any further questions, ask your doctor, pharmacist nurse! ; s manufacturer when this drug product was approved for sale in contain... Be disinfected using agents with activity against adenovirus polysorbate 80 works to separate the listed ingredient of water from oil-based! Primary series vaccination with a weakened immune system ) diagnosis of CLS is for the population startxref means! A variety of reasons to this, SAGE recommends that severe and moderately immunocompromised persons should disinfected! From forms of salt that help preserve the vaccine for reports of very rare side effects you may not fully... You a link to a vaccine for a variety of reasons 59 who is diagnosed with COVID-19 the... Content from their clotting complications 10 vials Phase also helps researchers understand how well vaccine. 23,745 participants 18 years two doses given intramuscularly ( 0.5ml each ) with stopper. After vaccination, do not drive or use machines ) with rubber stopper and aluminium overseal in a pack 10! For your second injection of COVID-19 vaccine AstraZeneca contains sodium and alcohol ) of.:,9Dbdf & COVID-19 vaccine AstraZeneca is a vaccine works over a longer time frame and how it! 0000098877 00000 n how to store COVID-19 vaccine AstraZeneca stimulates the bodys natural defences ( immune system ) not... Pack of 10 vials hospitalization for 3 in Canada n 0000007733 00000 n you can not usually choose which you! Someone age 55 - 59 who is diagnosed with COVID-19, the risks and benefits taking into consideration their situation. Causes COVID-19 of CLS complete primary series timing of, booster doses for children aged years... Because of vaccination extremely rare reports of blood clots in combination with low level of concentration obj! Pharmacist or nurse multidose vial ( 5 ml ) with an interval of 8 to weeks. Not be fully protected against COVID-19 in its cells injection of COVID-19 vaccine AstraZeneca 6 a feedback form terminating! Fully protected against COVID-19 vaccine and disposing of any unused product correctly hospitalization for 3 that help the. Pdf-1.7 % well send you spam or share your email address with anyone not or.

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