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. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . 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. b t@f&!+:eez8YY8.j 7 The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. Well send you a link to a feedback form. 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. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 0000104953 00000 n
It's only capable of delivering the DNA," he said. 5. Produced in genetically modified human embryonic kidney (HEK) 293 cells. [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. Nijmegen, 6545CG x]n@FwezA"+q*z
B-csD"%;>3a,7Mg>;M1crUukGavi%. endstream 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. Dosage level (s) 5 1010 vp (nominal). COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 0000002484 00000 n
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18 June 2021. Discard the vial and do not combine residual vaccine from multiple vials. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. endstream
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____________________________________________________________________________________. Previous Name: ChAdOx1 nCoV-19 Getty Images. There were ten participants who received two doses of AZD1222 one month apart. <>/Metadata 30 0 R>>
No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. Neither Pfizer nor Moderna . dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. any ingredients of COVISHIELD vaccine If you are breastfeeding If you are pregnant or plan to become pregnant WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE Read this Fact Sheet for information about the COVISHIELD Vaccine. 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). Dont worry we wont send you spam or share your email address with anyone. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . endstream
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Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. Get urgent medical attention if you get symptoms of a severe allergic reaction. endstream
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Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine, Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Novavax vaccine against COVID-19: What you need to know, The Bharat Biotech BBV152 COVAXIN vaccine against COVID-19: What you need to know, Independent Oversight and Advisory Committee, WHO Strategic Advisory Group of Experts on Immunization (SAGE), Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the ChAdOx1-S [recombinant] vaccine against COVID-19 (AstraZeneca COVID-19 vaccine AZD1222 Vaxzevria, SII COVISHIELD), The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Uncommon (infrequent) >1/1000 and < 1/100, The Astra-Zeneca vaccine recommendations have also been modified to indicate that either of the mRNA COVID-19 vaccines (Pfizer or Moderna) can be used as a second dose following a, The Astra-Zeneca vaccine can be used as a. 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 easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 569 0 obj
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Keep this medicine out of the sight and reach of children. 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 . 0
6 Renaissance Way As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. Liverpool, L24 9JW 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)). When autocomplete results are available use up and down arrows to review and enter to select. None of the ingredients in this vaccine can cause COVID-19. The last nine ingredients on the list are called 'excipients.' 0000006393 00000 n
The majority of these cases occurred within the first four weeks following vaccination. These include: y This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. . {zzZ`ntK?D6r|D#T$*
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In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . 4.6 Fertility, pregnancy and lactation Pregnancy There is a limited amount of data from the use of COVID-19 Vaccine (ChAdOx1-S [recombinant]) [COVID-19 Vaccine AstraZeneca]in pregnant women, or women who became pregnant after receiving the vaccine. 0000012641 00000 n
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Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. (, SARS-CoV-2 candidate vaccine ChAdOx1 nCoV-19 infection of human cell lines reveals a normal low range of viral backbone gene expression alongside very high levels of SARS-CoV-2 S glycoprotein expression (, ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques (, A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques (, Vaccines and Related Biological Products Advisory Committee 154th Meeting (, Information for UK recipients on COVID 19 Vaccine AstraZeneca (, Potential adjuvants for the development of a SARS-CoV-2 vaccine based on experimental results from similar coronaviruses (, What are the ingredients in the COVID-19 vaccines? If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. hbbd```b``5d4d""A$a0DEE4$U0 0000018147 00000 n
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The AstraZeneca vaccine is made up of a number of ingredients, including an active ingredient called an 'antigen' and several other non-active ingredients called 'excipients.' If you get any side effects, talk to your doctor, pharmacist or nurse. xVN@}W#E{I HTJB+!`)m;:KQyX99se Function. Updated on 13 June 2022 to ensure consistency of formatting. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. The average age of those who have experienced severe allergic reactions so far is . 0000007733 00000 n
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See section 4. Keep this leaflet. 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. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. Moderna COVID-19 vaccine. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 57 0 obj
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Solution for injection. 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. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. endobj The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Article number: 33474. 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. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. WHO does not recommend discontinuing breastfeeding because of vaccination. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 0000093171 00000 n
This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . 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. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. hbbd```b``3@$1dYL`)`5w. 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. 0000003540 00000 n
Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 0000003715 00000 n
. 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 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. Six of the 28 died from their clotting complications. 0000009880 00000 n
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. Documents provided by AstraZeneca: Study Protocol [PDF] February 19, 2021 Statistical Analysis Plan [PDF] February 28, 2021 More Information Go to Additional Information: Statistical Analysis Plan (SAP) D8110C00001-CSP-amendment-6_Redacted.pdf CSR Synopsis Publications: CDC. 0000093244 00000 n
Use all vaccine in the vial within 6 hours after first puncture. 0000005556 00000 n
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. Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. %PDF-1.7
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8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. are no data yet for Omicron. 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. Treatment for: Prevention of COVID-19. 0000132090 00000 n
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. See the end of section 4 for how to report side effects. WHO recommends focusing on achieving high first dose coverage by extending the inter-dose interval, whilst continuing to maximize second dose coverage of vulnerable groups in the context of variants of concern. endobj The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. Some cases were life-threatening or had a fatal outcome. 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. 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 . This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. EDTA is not listed as an ingredient in the Johnson &. 803 0 obj
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The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. It is a proven, safe and relatively old approach. 0000055862 00000 n
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 0000103790 00000 n
This means that it is essentially 'sodium-free'.. In countries with ongoing Once this enters the body, it tells your cells to make copies of the spike protein. 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. x
P^0^N&8:Cssfo"E$hq(#^G78@ Browse our homepage for up to date content or request information about a specific topic from our team of scientists. 0000098749 00000 n
hb```Y@(&(fL(aW$Xz$7 Some affected patients had a previous diagnosis of CLS. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). startxref
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. 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). If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). <]/Prev 553136>>
This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). 0000106271 00000 n
53 0 obj To help us improve GOV.UK, wed like to know more about your visit today. 0
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.. People under the age of 40 are to be offered an alternative to the Oxford-AstraZeneca vaccine in the UK as a precaution, after a review of all the latest evidence by vaccine advisers and safety . According to the information that AstraZeneca and the University of Oxford presented to the United Kingdom's vaccine regulatory agency, this vaccine contains: The vaccine does not include any human or animal products, thimerosal, gelatin, or formaldehyde. 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. brain, liver, bowel, spleen). 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. You can help by reporting any side effects you may get. Contact your doctor or pharmacist if you have any questions about . %PDF-1.7
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Some cases had a fatal outcome. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . AZD1222 FDA Approval Status. O'`` r/ RV"Lj~=n%8w?C
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This product contains genetically modified organisms (GMOs). Vaccine efficacy tended to be higher when the interval between doses was longer. 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. What is the evidence for vaccine efficacy and safety in adults (18-59 years)? 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. 0000014217 00000 n
SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. WHO does not recommend pregnancy testing prior to vaccination. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/
,6aYmk}*Oko8/q1(z h^ONc! Additional Information If you have questions, visit the website or call the telephone number provided serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr syndrome [GBS]), rapid swelling under the skin in areas such as the face, lips, mouth and throat (which may cause difficulty in swallowing or breathing) (angioedema), capillary leak syndrome (a condition causing fluid leakage from small blood vessels), very low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, Blood disorders), blood clots in the brain, not associated with low level of blood platelets (see section 2, Blood disorders), inflammation of the spinal cord which may cause muscle weakness, localised or radiating back pain, bladder and bowel symptoms and changes in sensation (transverse myelitis). We also use cookies set by other sites to help us deliver content from their services. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. xc```b``g`a```d@ A+s4@s60J:Up95PA? 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. %PDF-1.7
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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. hbbd``b` $HpXAv DL) %PDF-1.7 2020 has been a difficult year for all, but has seen 58 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) be developed and in clinical trials,1 with some vaccines reportedly having more than 90% efficacy against COVID-19 in clinical trials. 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. 0000100169 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. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. "It can't give you an infection. Each vial contains 8 doses of 0.5 ml. 0000102287 00000 n
In . However, it is not confirmed whether these events were due to the vaccine. We comply with the HONcode standard for trustworthy health information. L-histidine hydrochloride monohydrate (amino acid) Magnesium chloride hexahydrate (salt) Polysorbate 80 (surfactant) Ethanol (alcohol) Sucrose (sugar) Sodium chloride (salt) Disodium edetate dihydrate (salt) Water for injections (diluent) The vaccine does not include any human or animal products, thimerosal, gelatin, or formaldehyde. 0000006503 00000 n
You cannot usually choose which vaccine you have. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. 0000016862 00000 n
The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. Health information in your inbox, every other week. You may access the guidance document here. 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. When these blood clots do occur, they may be in unusual or atypical locations (e.g. 55 0 obj You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. 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). 0000097826 00000 n
If you previously had Guillain-Barr syndrome (temporary loss of feeling and movement) or transverse myelitis (inflammation of the spinal cord) after being given COVID-19 Vaccine AstraZeneca. The 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? 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. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. 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. endstream
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