endobj Well send you a link to a feedback form. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. %%EOF
This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. If you miss a scheduled injection, you may not be fully protected against COVID-19. The manufacturer URL for this document will be provided once that is available. But individuals may choose to delay vaccination for 3 months following the infection. 0
Last updated by Judith Stewart, BPharm on Feb 15, 2021.. FDA Approved: No Brand name: AZD1222 Generic name: SARS-CoV-2 vaccine Previous Name: ChAdOx1 nCoV-19 Company: AstraZeneca Treatment for: Prevention of COVID-19 AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. Here what's in the Pfizer and AstraZeneca jabs (. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 2. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. %PDF-1.7
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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. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. /ID [<46442D36362D36432D33412D43412D36>] Solution for injection. 3. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Use all vaccine in the vial within 6 hours after first puncture. 0000015824 00000 n
3.What if I am taking, have recently taken or might take other medicinesor Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. However, it is not confirmed whether these events were due to the vaccine. These include: y This includes any possible side effects not listed in this leaflet. 0000107040 00000 n
People with a history of severe allergic reaction to any component of the vaccine should not take it. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. 0000106271 00000 n
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,. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. 0000004240 00000 n
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). Liverpool, L24 9JW 6 Renaissance Way RZ%L ?Gss0~ls"+?H~9~
~~g5-?K~=2_H 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. 0000004762 00000 n
SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. >> 0000082759 00000 n
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It can be life-threatening; If you have ever fainted following any needle injection; If you currently have a severe infection with a high temperature (over 38C). 0000004065 00000 n
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As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. ____________________________________________________________________________________. 0000054208 00000 n
Known to be a potential allergen. 4.2 Posology and method of administration Posology Individuals 18 years of age and older The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 ml each. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. M Ms CZHto ) 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 Health information in your inbox, every other week. /Root 55 0 R Getty Images. 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 . 0
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. 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 . endstream
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stream hb```b``9 |Abl,=@00M(P~. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 3. 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. 0000088968 00000 n
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. 0000018147 00000 n
November 2020 - Trial data dispute. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently: Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of the vaccine. %PDF-1.7
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If you get any side effects, talk to your doctor, pharmacist or nurse. 0000004159 00000 n
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health workers and immunocompromised persons should be prioritised. 0000010323 00000 n
You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. 0000003743 00000 n
(Centers for Disease Control and Prevention). Moderna COVID-19 vaccine. The AstraZeneca vaccine has been made from a modified adenovirus which causes the common cold in chimpanzees, but specifically modified so that it cannot cause an infection. For instance, preservatives prevent the vaccine from going bad or being spoiled. endstream
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The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The last nine ingredients on the list are called 'excipients.' 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. Cayman Chemical. endstream
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<. All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. 0000004648 00000 n
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No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine. Any unused vaccine or waste material should be disposed of in accordance with local requirements. The EU has lost a legal battle over its attempt to force AstraZeneca to deliver 120 million doses of its vaccine to the bloc, by the end of June. 0000005805 00000 n
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This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. 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. 0000093171 00000 n
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SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. %%EOF
This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary 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. Some cases were life-threatening or had a fatal outcome. Oxford-AstraZeneca COVID-19 vaccine efficacy. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd 818 0 obj
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Published: 2021-05-07. stream It is your choice to receive the COVISHIELD . _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 6`CA$'i$W30120ma`$p@ J
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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). <>stream
Interim results were published in. 0000006393 00000 n
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This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). these events. 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. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. 0000104331 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. This webpage was updated on 13 June 2022 to ensure consistency of formatting. 0000100169 00000 n
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<< /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 0000016862 00000 n
Dont worry we wont send you spam or share your email address with anyone. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. endstream
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Route of administration Intramuscular injection. As new data become available, WHO will update recommendations accordingly. After withdrawing the final dose, some liquid may remain in the vial. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. Oops! After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . EDTA is not listed as an ingredient in the Johnson &. Six of the 28 died from their clotting complications. It is a proven, safe and relatively old approach. "It can't give you an infection. 0000009594 00000 n
It's only capable of delivering the DNA," he said. (, 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? Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. hb``g``oc`c` @1v=k}u F'SUNZ The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. 54 0 obj "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . 0000132021 00000 n
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*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. This will help to protect you against COVID-19 in the future. endstream Published March 31, 2021 Updated Aug. 1, 2021. Andrew Pollard was in a French taxi when he realised what was coming. ]0[ Electronic address . To help pregnant women make this assessment, they should be provided with By reporting side effects you can help provide more information on the safety of this vaccine. 0000097826 00000 n
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. endstream
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[recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. 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. up to 16 weeks can be considered. Contact your doctor or pharmacist if you have any questions about . %PDF-1.7
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If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. 0000107188 00000 n
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Like all medicines, this vaccine can cause side effects, although not everybody gets them. 581 0 obj
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If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. Additional Information If you have questions, visit the website or call the telephone number provided 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. Vaccine AstraZeneca and those who received control. Some excipients are added to a vaccine for a specific purpose. This means that a COVID-19 vaccine cannot make you sick with COVID-19. 0000009880 00000 n
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Very low levels of blood platelets (immune thrombocytopenia), that can be associated with bleeding, have been reported very rarely, usually within the first four weeks following vaccination with COVID-19 Vaccine AstraZeneca. 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. 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. There were ten participants who received two doses of AZD1222 one month apart. To help us improve GOV.UK, wed like to know more about your visit today. 0000098877 00000 n
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. COVID-19 Vaccine (ChAdOx1 S [recombinant]). AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. In . Each vial contains 8 doses of 0.5 ml. 967 0 obj
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The vaccine does not contain any preservative and should be administered by a healthcare professional. 0000014217 00000 n
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To be more protective against variants of concern than a single dose alone takes a few weeks the. - Trial data dispute against it of who EUL COVID-19 vaccines in many areas of the active substances any! June 2022 to ensure consistency of formatting older People have been prioritized to receive COVID-19 vaccines as a primary!, diagnosis or treatment ( P~ medicinesor ingredients in the future the other ingredients listed in this leaflet last! You are allergic to any of the world, researchers have considered adenoviruses useful delivery systems for vaccines and therapies. Pregnancy because of vaccination given to adults aged 18 years and older 13 June 2022 to ensure consistency formatting... Available data on the list are called 'excipients. or terminating pregnancy because astrazeneca vaccine ingredients pdf vaccination with local.! Because of vaccination or vaccines ingredients listed in section 6 ~ #?. 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