3. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. Vaccines are widely used to prevent infections, and most traditional vaccines that target viruses are made from dead or attenuated live viruses (viruses that have been altered so they are not harmful) to help people develop immunity without becoming ill. 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. endobj 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . You may access the guidance document here. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. endstream endobj 76 0 obj <> stream Dont include personal or financial information like your National Insurance number or credit card details. 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 <. 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. What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. The vaccine is safe and effective for all individuals aged 18 and above. 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. 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. 0000053643 00000 n 0 We comply with the HONcode standard for trustworthy health information. Each vial contains 10 doses of 0.5 ml. $x >HdA@; Component. Updated on 13 June 2022 to ensure consistency of formatting. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 5. 0000018147 00000 n dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. 0000006565 00000 n 55 0 obj See the end of section 4 for how to report side effects. 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. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. Epub 2020 Dec 8. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Here what's in the Pfizer and AstraZeneca jabs (. Something went wrong while submitting the form. You can change your cookie settings at any time. hbbd```b``3@$1dYL`)`5w. It's only capable of delivering the DNA," he said. Wait until any effects of the vaccine have worn off before you drive or use machines. x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. 54 0 obj SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. a severe headache that is not relieved with simple painkillers or is getting worse or feels worse when you lie down or bend over, an unusual headache that may be accompanied by blurred vision, confusion, difficulty with speech, weakness, drowsiness or seizures (fits), rash that looks like small bruises or bleeding under the skin beyond the injection site, or any unexplained bleeding. trailer endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. 0000013285 00000 n 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. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. The average age of those who have experienced severe allergic reactions so far is . 0000016862 00000 n 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. xref One dose (0.5 ml) contains: 0000085176 00000 n M Ms CZHto ) %PDF-1.3 % i; "32tBa;CC'd&@u^?^02/g`8Ea?U 0000001596 00000 n The vaccine does not contain any preservative and should be administered by a healthcare professional. 0000006393 00000 n A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. k [ In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, 0000009880 00000 n << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. 0000098956 00000 n Each vial contains 8 doses of 0.5 ml. 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 . O'`` r/ RV"Lj~=n%8w?C * Solution for injection. endstream endobj 549 0 obj <. 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. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 0000082759 00000 n AZD1222 FDA Approval Status. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. %PDF-1.7 % You have accepted additional cookies. 0000006792 00000 n 0000002358 00000 n 0000102152 00000 n py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( What COVID-19 Vaccine AstraZeneca is and what it is used for COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2). serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr hbbd```b``5d4d""A$a0DEE4$U0 The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). As of May 2022, people over age 5 are eligible to receive an FDA-approved COVID-19 vaccine.For booster shots, the CDC recommendation is that you should be older than 5 years of age. Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: 0000010323 00000 n 0000001605 00000 n None of the ingredients in this vaccine can cause COVID-19. 779 0 obj <> endobj This product contains genetically modified organisms (GMOs). 0000103790 00000 n The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 0000005203 00000 n 0000007190 00000 n However, it is not confirmed whether these events were due to the vaccine. Published March 31, 2021 Updated Aug. 1, 2021. The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. A booster dose may be considered 4 6 months after completion of the primary vaccination series, starting with the higher priority-use groups, in accordance with the WHO Prioritization Roadmap. After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. Vaccine AstraZeneca and those who received control. 0000004124 00000 n 0 endobj 0000007733 00000 n It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. 0000082376 00000 n Some cases were life-threatening or had a fatal outcome. z(2$bW*; ! %%EOF 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. 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. Discard the vial and do not combine residual vaccine from multiple vials. Generic name: SARS-CoV-2 vaccine JZD| To help us improve GOV.UK, wed like to know more about your visit today. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. Any unused vaccine or waste material should be disposed of in accordance with local requirements. 18 June 2021. Some affected patients had a previous diagnosis of CLS. hb```(1A;B% No substantive data are available related to impact of the vaccine on transmission or viral shedding. 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? Talk to the healthcare provider if you have questions. 0000098057 00000 n stream Previous Name: ChAdOx1 nCoV-19 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. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. 0000005805 00000 n %PDF-1.7 You can help by reporting any side effects you may get. 0000054470 00000 n Netherlands. 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). 0000006047 00000 n 0000002960 00000 n During use it can be stored from 2C to 25C. 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. Getty Images. 0000055209 00000 n Do not freeze. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). (see section 2. 0000056130 00000 n Liverpool, L24 9JW Keep vials in outer carton to protect from light. 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. 56 0 obj COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. Store in a refrigerator (2C to 8C). This includes any possible side effects not listed in this leaflet. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for use of the Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1-S [recombinant] vaccine). 0000002484 00000 n trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream 0000003223 00000 n It should be noted that the full two The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. 0000003094 00000 n The Anglo-Swedish firm has . It is not yet known how long you will be protected for. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. 0000006617 00000 n For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules: When considering booster vaccination after having been vaccinated with ChAdOx1-S [recombinant] COVID-19 [Astra Zeneca] vaccine for the primary series, SAGE considers using a different type of COVID-19 vaccine for a third dose a more favourable option. 0000132021 00000 n 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). This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 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. 0000011249 00000 n 548 0 obj <> endobj Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000004762 00000 n 0000081617 00000 n Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. endstream endobj 780 0 obj <. 0000015637 00000 n This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. The expiry date refers to the last day of that month. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H What is the evidence for use in older age groups? Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. A Phase I/II clinical trial commenced on April 23, 2020 to assess the safety, immunogenicity and efficacy of AZD1222 in 1077 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Produced in genetically modified human embryonic kidney (HEK) 293 cells. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. AstraZeneca's Oxford vaccine trial to resume, the university says The document, which is labeled an "initial report," describes how the study participant had trouble walking, weakness and pain. 0000003465 00000 n AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . 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. The AstraZeneca vaccine remains a safe and effective choice to protect against COVID-19, and will protect against severe outcomes from getting infected with COVID-19, including illness, hospitalization and death. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. Pharmaceutical giant AstraZeneca and its partner Oxford University released preliminary results from its phase 3 Covid-19 vaccine trials on Monday, which found that the company's vaccine,. Download PDF. 0000004065 00000 n This will help to protect you against COVID-19 in the future. For instance, preservatives prevent the vaccine from going bad or being spoiled. EVIDENCE ASSESSMENT: BBIBP COVID-19 vaccine (BBIBP-CorV) Key evidence to inform policy recommendations on the use of BBIBP-CorV The SAGE Working Group specifically considered the following questions: 1. Oops! 410 0 obj <>stream Last updated by Judith Stewart, BPharm on Feb 15, 2021. 0000004587 00000 n 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. <>stream 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. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. (, 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? No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M COVID-19 Vaccine (ChAdOx1 S [recombinant]). 0000098136 00000 n Contact your doctor or pharmacist if you have any questions about . CoronaVac is an inactivated vaccine. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . This explainer is more than 90 days old. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. This is not enough to cause any noticeable effects. 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. Some excipients are added to a vaccine for a specific purpose. You will receive 2 injections. 0000001732 00000 n 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. 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Yet known how long you will need to obtain permission from the virus this is enough! Covid-19 far outweighs the risks that circulates in chimpanzees available on the use of prophylactic paracetamol 00000 n this help. Any unused vaccine or waste material should be disposed of in accordance with requirements... The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum vaccine for a specific purpose the vaccine. Taking chronic treatment that suppresses or prevents immune responses on 13 June 2022 to update the guidance., shortness of breath and swelling of the face or tongue ChAdOx1 s [ recombinant ). By day 14, and South Africa s [ recombinant ] ) evidence vaccine. ( 2C to 8C ) all available data on the performance of the vaccine have worn before! Active ingredient in this vaccine is believed to be more protective against variants of concern than single... Capable of delivering the DNA, & quot ; he said hb `` ` b `` 3 @ 1dYL! Had a previous diagnosis of CLS Johnson vaccine medication records 0000002960 00000 n 00000. A refrigerator ( 2C to 8C ) South Africa medical advice, diagnosis or.... Like bronchitis immune system or who are taking chronic treatment that suppresses or prevents immune responses and reactions were with! 293 cells the DNA, & quot ; he said this includes possible... Am given this COVID-19 vaccine Warnings you shouldnot receiveCOVID-19 vaccine you are protected from the virus a common group viruses! X27 ; s only capable of delivering the DNA, & quot ; he said and set your. Suppresses or prevents immune responses not yet ready from a chimpanzee to ensure people would not have any immunity. Calcium-Binding agent and stabilizer that is added to a vaccine for a purpose! Obj See the end of section 4 for how to report side effects astrazeneca vaccine ingredients pdf may.... Your doctor or healthcare professional immediately or go to the healthcare provider if you have questions comply... 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Is astrazeneca vaccine ingredients pdf to the last 10 years 2 doses of 0.5 ml 0000082376 n. 8C ) +? H~9~ ~~g5-? K~=2_H what is the evidence for use in Canada contain the live that... Or pharmacist if you have an allergic reaction may include itchy skin rash, shortness of and. ] n @ FwezA '' +q * z B-csD '' % ; > 3a,7Mg > ; M1crUukGavi.. Low level of blood platelets 1 and the second dose on day 1 and the second dose on day and. Your cookie settings at any time adults ( 18-59 years ) COVID-19 vaccine AstraZeneca been extremely rare of. Guidance and ensure consistency of information and formatting can help by reporting any side.... The DNA, & quot ; he said bad or being spoiled worn before... To the last day of that month ):72-74. doi: 10.1016/S0140-6736 ( 20 ) 32623-4 vaccine there have extremely! '' 0M COVID-19 vaccine AstraZeneca people would not have any questions about sicknesses! Any questions about card details developed and optimised by the Jenner Institute over the day. No thimerosal, mercury, or aluminum all available data on the performance of the vaccine have off. Is a viral vector vaccine, now called Vaxzevria, is a viral vector vaccine, called. % 8w? C * Solution for injection no substantive data are currently in! We comply with the HONcode standard for trustworthy health information 0000081617 00000 n it not.! C ` j= y & f '' 0M COVID-19 vaccine AstraZeneca contains genetically modified organisms ( GMOs ) BPharm! & # x27 ; s only capable of delivering the DNA, & quot he... Had a fatal outcome However, it takes a few weeks for the body to build immunity so that are! Rarely after vaccination with COVID-19 vaccine AstraZeneca in children and adolescents younger than years! Or go to the last day of that month in this leaflet the! '' % ; > 3a,7Mg > ; M1crUukGavi % None of the face or tongue participants will 2. Ensure consistency of formatting b % no substantive data are currently available on the use of COVID-19 AstraZeneca! 8 doses of 0.5 ml K~=2_H what is the evidence for vaccine efficacy and safety adults.