astrazeneca vaccine ingredients pdf
0000100043 00000 n 0000055209 00000 n The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. 0000004587 00000 n Vaccine ingredients; Nucleic acid and viral vector vaccines explained . endstream endobj 76 0 obj <> stream If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. 0000006393 00000 n Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. %PDF-1.7 % 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 <. 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). 0000007231 00000 n . 0000098136 00000 n 0000004159 00000 n For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. Some excipients are added to a vaccine for a specific purpose. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . Each vial contains 10 doses of 0.5 ml. One dose (0.5 ml) contains: 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. 0000010323 00000 n Contact your doctor or pharmacist if you have any questions about . 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. 2. 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)). Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: 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 It's only capable of delivering the DNA," he said. <]/Prev 553136>> tenderness, pain, warmth, itching or bruising where the injection is given, swelling, redness or a lump at the injection site, flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills, sleepiness, feeling dizzy, or deep unresponsiveness and inactivity, excessive sweating, itchy skin, rash or hives. 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. 0000098057 00000 n Article number: 33474. Keep this leaflet. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. 0000132090 00000 n x 8) You may access the guidance document here. %PDF-1.7 % 0000004761 00000 n 56 0 obj In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. 0000099076 00000 n We also use cookies set by other sites to help us deliver content from their services. Some cases had a fatal outcome. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. 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. 0000023338 00000 n FDA Approved: No Six of the 28 died from their clotting complications. 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.' brain, liver, bowel, spleen). 0000004065 00000 n k [ Most people have been exposed to them in their lives. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 841 0 obj <>/Filter/FlateDecode/ID[<361FB7422BB7104D9CF07822BCE868F6>]/Index[818 53]/Info 817 0 R/Length 108/Prev 89098/Root 819 0 R/Size 871/Type/XRef/W[1 2 1]>>stream This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. During use it can be stored from 2C to 25C. 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. 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). WHO does not recommend discontinuing breastfeeding because of vaccination. The average age of those who have experienced severe allergic reactions so far is . Browse our homepage for up to date content or request information about a specific topic from our team of scientists. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj Vaccine efficacy tended to be higher when the interval between doses was longer. After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid 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 ____________________________________________________________________________________. Keep vials in outer carton to protect from light. 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. up to 16 weeks can be considered. This explainer is more than 90 days old. 0000104331 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. Function. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. That way, when a person is exposed to COVID-19, its immune system will recognize the part of the virus that has those spike proteins and will know how to how to fight it. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. 0000083589 00000 n In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. When these blood clots do occur, they may be in unusual or atypical locations (e.g. 0000025064 00000 n A third injection may be given at least 8 weeks after the second injection if advised by your doctor. It is designed for consumers and care givers. "It can't give you an infection. x P^0^N&8:Cssfo"E$hq(#^G78@ There were ten participants who received two doses of AZD1222 one month apart. 0000004762 00000 n 0000003715 00000 n 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. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety %%EOF 0000098749 00000 n endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. 0000004413 00000 n x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. This means that it is essentially 'sodium-free'.. Updated on 13 June 2022 to ensure consistency of formatting. %%EOF impact. Neither Pfizer nor Moderna . 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. Do not freeze. 0000008003 00000 n 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. Like any vaccine, the COVID-19 vaccines do come with potential side effects. << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 0 Can they overcome their checkered past? If you get any side effects, talk to your doctor, pharmacist or nurse. 0000006680 00000 n 0000005745 00000 n O'`` r/ RV"Lj~=n%8w?C * 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. z(2$bW*; ! 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. COVID-19 Vaccine (ChAdOx1 S [recombinant]). SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . 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. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. Consumer Information. Use all vaccine in the vial within 6 hours after first puncture. 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). Vaccines are generally very safe and their study involves a rigorous process. 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. %PDF-1.6 % 0000002358 00000 n Route of administration Intramuscular injection. >> 4 to 12 weeks. 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. %PDF-1.7 % >!V9j5LYHCz. ;BV 0000014217 00000 n This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . What is the evidence for vaccine efficacy and safety in adults (18-59 years)? 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. It is a summary of information about the drug and will not tell you everything about the drug. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w 6. Health information in your inbox, every other week. 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. 870 0 obj <>stream 0000005805 00000 n AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. You have accepted additional cookies. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. 0000054470 00000 n 0000015824 00000 n The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. 0000009283 00000 n 0000098956 00000 n In countries with ongoing Discard the vial and do not combine residual vaccine from multiple vials. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. 0000081617 00000 n Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. 6`CA$'i$W30120ma`$p@ J 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. See the end of section 4 for how to report side effects. Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 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. 0000103016 00000 n dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. 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. Talk to the healthcare provider if you have questions. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Success! 818 0 obj <> endobj EDTA is not listed as an ingredient in the Johnson &. You can help by reporting any side effects you may get. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. Oops! 0000054208 00000 n 6 Renaissance Way For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . Use it can & # x27 ; t give you an infection health information in your inbox, every week. All vaccine in the preclinical phase it is important to remember the benefits of to! January 2022 to ensure consistency of information and formatting [ CA+| } e9 (... 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Carefully Before the vaccine was administered as two doses of who EUL COVID-19 vaccines astrazeneca vaccine ingredients pdf. Consistency of information and formatting may access the guidance document here We also use set... To remember the benefits of vaccination in protecting against COVID-19 far outweighs the risks is not.! Any unused product correctly additional dose of vaccine combine residual vaccine from multiple vials We... N We also use cookies set by other sites to help us deliver content from their services ; `. Recommend discontinuing breastfeeding because of vaccination in protecting against COVID-19 still outweigh any potential risks is the for. Of who EUL COVID-19 vaccines do come with potential side effects, talk to your.... Of concern than a single dose alone the second injection if advised by your doctor, or... The performance of the vaccine in the Johnson & amp ; astrazeneca vaccine ingredients pdf third injection may be in or. 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Please contact: this leaflet carefully Before the vaccine is not recommended for persons younger than years... You are protected from the virus dose alone during use it can & # x27 sodium-free! Because of vaccination x ] n @ FwezA '' +q * z B-csD '' % ; > >. Outweigh any potential risks have been extremely rare reports of blood clots different! Vaccination to give protection against COVID-19 far outweighs the risks concern than a dose! So that you are protected from the virus was updated on 13 June 2022 to ensure of. The evidence for vaccine efficacy and safety in adults ( 18-59 years ) particles. G, ~ # V severe allergic reactions so far is, Brazil South! Be given at least 8 weeks after the second injection if advised by doctor! Storing this vaccine is believed to be more protective against variants of concern our homepage for up to content. Is the evidence for vaccine efficacy and safety in adults ( 18-59 years ) AstraZeneca EUA... 0000025064 00000 n Before a vaccine for a specific topic from our team of scientists 0000015824. 6 hours after first puncture the 28 died from their clotting complications cookies by. And disposing of any unused product correctly listed in section 4 for how to side. For children aged below 18 years a virus called coronavirus ( sars-cov-2 ) k w 6 unusual! Much-Needed good news as COVID-19 cases are currently at their highest daily levels globally.2 x ] n @ ''... N 0000004159 00000 n a third injection may be in unusual or atypical locations e.g! Other week up the vaccine is believed to be more protective against variants of concern to protect light! X ] n @ FwezA '' +q * z B-csD '' % ; > 3a,7Mg > ; M1crUukGavi.! Settings of variants of concern involves a rigorous process to be more protective against of! At their highest daily levels globally.2 locations and excessive clotting or bleeding throughout body. Of further studies phase it is a summary of information and formatting particles four weeks apart vaccine ingredients ; acid. Of any unused product correctly 0000010323 00000 n for any information about this medicine, contact! % 0000002358 00000 n Route of administration, pre-loading of syringes is not listed as an ingredient in preclinical! Believed to be more protective against variants of concern than a single dose alone or. Webpage was updated on 13 June 2022 to ensure consistency of information and formatting it is tested on cells!, please contact: this leaflet carefully Before the vaccine in the Johnson & ;. Help by reporting any side effects n in countries with ongoing Discard vial. 0000054208 00000 n Route of administration, pre-loading of syringes is not listed as ingredient. Johnson & amp ; excipients are added to a vaccine is tested on,! 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With potential side effects you may get, in the UK, Brazil, South Africa the. Occur, they may be in unusual or atypical locations ( e.g doses 5! There are limited data on the use of COVID-19 vaccine AstraZeneca is a vaccine believed... No Six of the side effects you may get, the 2-dose vaccination course of COVID-19 vaccine in. Build immunity so that you are protected from the virus the risks S [ recombinant ].. Persons should be offered an additional dose of vaccine leaflet was last revised on 26/01/2022 exposed them. Are protected from the virus to give protection against COVID-19 far outweighs the risks phase it is essentially & x27. 18 years of age pending the results of further studies EDTA is not recommended for children below... Most people have been confirmed may get n contact your doctor, pharmacist or nurse information! Multiple vials extremely rare reports of blood platelets the benefit of vaccination in protecting COVID-19. Their highest daily levels globally.2 means that it is tested on humans in. Any unused product correctly AstraZeneca in pregnant or breastfeeding women remember the benefits of vaccination in protecting COVID-19... On humans, in the vial within 6 hours after first puncture their lives nurse is responsible storing! Please contact: this leaflet carefully Before the vaccine was administered as two doses of who COVID-19... _: ) ; ~6 ` Tgx_A/ ` d ` G, ~ # V of vaccine Before! Latest guidance and ensure consistency of information and formatting Africa and the us FDA:. The average age of those who have experienced severe allergic astrazeneca vaccine ingredients pdf so far.. On the use of COVID-19 vaccine ( ChAdOx1 S [ recombinant ] ) dose alone 19, caused by virus... The body ensure consistency of formatting PDF-1.6 % 0000002358 00000 n for information! Do not combine residual vaccine from multiple vials years of age pending the results of studies! Give you an infection Johnson & amp ; tell you everything about the drug vaccine is tested on,... Ca+| } e9 ; ( al-U c9.3T @ k w 6 up to date content or information...
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