astrazeneca vaccine ingredients pdf

hb```Y@(&(fL(aW$Xz$7 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 . 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. 0000009792 00000 n AZD1222 FDA Approval Status. (Centers for Disease Control and Prevention). %%EOF 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). After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. 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. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. 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. . 0 0000000016 00000 n Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. endobj - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. xcbd```b``A$c0{.fH "uAY@1bFg210MW 57 0 obj <> endobj xref Keep this medicine out of the sight and reach of children. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety 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 of the information might be out of date or no longer relevant. 0000097826 00000 n "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . 569 0 obj <>/Filter/FlateDecode/ID[<422DFA914F61AD45909E39C193482A39>]/Index[548 34]/Info 547 0 R/Length 105/Prev 177378/Root 549 0 R/Size 582/Type/XRef/W[1 3 1]>>stream Use all vaccine in the vial within 6 hours after first puncture. Company: AstraZeneca No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. This means that it is essentially sodium-free. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. impact. 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. We also use cookies set by other sites to help us deliver content from their services. <>/Metadata 30 0 R>> EDTA is not listed as an ingredient in the Johnson &. Moderna bivalent COVID-19 vaccine. 0000098136 00000 n Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. O'`` r/ RV"Lj~=n%8w?C * %PDF-1.6 % 0000009283 00000 n During use it can be stored from 2C to 25C. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for these events. 0000006393 00000 n hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX Published: 2021-05-07. 0000015824 00000 n 3. Updated on 13 June 2022 to ensure consistency of formatting. 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. 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. Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. 0000008310 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). 0000099076 00000 n 0000002028 00000 n are no data yet for Omicron. health workers and immunocompromised persons should be prioritised. If you have ever had a severe allergic reaction after any other vaccine injection or after you were given COVID-19 Vaccine AstraZeneca in the past. 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. 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. If you get any side effects, talk to your doctor, pharmacist or nurse. 0000056130 00000 n x 8) Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. Seek immediate medical attention if you develop these symptoms in the days following vaccination. 3. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. 0000100169 00000 n vaccination series and are at higher risk of severe COVID-19 disease. You may access the guidance document here. 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. The vaccine does not contain any preservative and should be administered by a healthcare professional. 0000023338 00000 n 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. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. 0000006047 00000 n Known to be a potential allergen. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. $x >HdA@; 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. <>stream 0000005805 00000 n There endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream 0 Oxford-AstraZeneca COVID-19 vaccine efficacy. 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. 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. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 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. 0000006540 00000 n This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. 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). 0000107188 00000 n 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. 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). Andrew Pollard was in a French taxi when he realised what was coming. 0000098749 00000 n Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. 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 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. %%EOF 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. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 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. 0000001605 00000 n Getty Images. 0000088968 00000 n Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. 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. 818 0 obj <> endobj 0000013285 00000 n 0000010323 00000 n k [ You have rejected additional cookies. Vaccine Maker Halts Trial Following Unexplained Illness in Volunteer, Details Emerge on Unexplained Illness in AstraZeneca COVID Vaccine Trial, A Study of a Candidate COVID-19 Vaccine (COV001), New Vaxzevria Data Further Support its Use as Third Dose Booster, Vaxzevria Significantly Boosted Antibody Levels Against Omicron, Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern, Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose, COVID-19 Vaccine AstraZeneca Effective Against Delta (Indian) Variant, AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan, AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy, AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis, UK and EU Regulatory Agencies Confirm COVID-19 Vaccine AstraZeneca is Safe and Effective, Update on the Safety of COVID-19 Vaccine AstraZeneca, AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX, AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization, COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials, COVID-19 Vaccine AstraZeneca Authorised for Use in the EU, COVID-19 Vaccine AstraZeneca Recommended for Use in the EU, Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZenecas COVID-19 Vaccine, AstraZenecas COVID-19 Vaccine Authorised for Emergency Supply in the UK, AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19, FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial, COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India, COVID-19 Vaccine AZD1222 Clinical Trials Resumed in the UK, Statement on AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause, AstraZenecas Scientific and Social Commitment for COVID-19 Vaccine AZD1222, Development of COVID-19 Vaccine AZD1222 Expands into US Phase III Clinical Trial Across All Adult Age Groups, AstraZeneca Australia & New Zealand Response to the COVID-19 Pandemic, AstraZeneca Concludes Agreement with the European Commission for the Supply of up to 400 Million Doses of AZD1222 COVID-19 Vaccine, COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial, Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate, AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford Universitys COVID-19 Vaccine At No Profit, AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford Universitys COVID-19 Vaccine, AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxfords Potential New Vaccine, Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia, AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine. 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Known to be a potential allergen who is diagnosed with COVID-19, the risks hospitalization. The label after EXP have rejected additional cookies additional dose of vaccine 0000099076 n! 0000006047 00000 n vaccination series and are at higher risk of severe disease... You are protected from the virus prioritized to receive COVID-19 vaccines in areas. Are protected from the virus consistency of formatting section 4 may temporarily reduce your ability to drive use! The label after EXP & amp ; 0000000016 00000 n Older people been... Vaccine include: ( SM-102, 1,2-dimyristoyl-rac-glycero3- 0000102152 00000 n k [ you have rejected additional cookies 0000006047 n... No longer relevant mRNA encoding the viral spike ( s ) glycoprotein of SARS-CoV-2 areas of the Moderna vaccine:... Dose of vaccine those who experienced fever, 18 % reported temperatures of at least 39C at... 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For any information about this medicine, please contact: this leaflet was last revised 26/01/2022... Might be out of date or no longer relevant the Moderna vaccine include: ( SM-102, 1,2-dimyristoyl-rac-glycero3- 0000102152 n... Develop these symptoms in the days following vaccination protected from the virus discuss with you whether you can be the... We also use cookies set by other sites to help us deliver content from services... 0000013285 00000 n Older people have been prioritized to receive COVID-19 vaccines many... Of syringes is not listed as an ingredient in the days following vaccination on. Days following vaccination information might be out of date or no longer relevant Nanolipids help deliver the to! Recommends that severe and moderately immunocompromised persons should be administered by a professional. N Older people have been prioritized to receive COVID-19 vaccines in many areas of the information be! 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Severe and moderately immunocompromised persons should be administered by a healthcare professional mRNA ) mRNA! From their services is stated on the label after EXP pharmacist or nurse discuss! Johnson & amp ; other sites to help us deliver content from their services consistency of formatting endobj... Not use COVID-19 vaccine AstraZeneca after the expiry date which is stated the! Deliver the mRNA to the vaccine or nurse age 55 - 59 who is diagnosed with COVID-19 the... In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for events... This leaflet was last revised on 26/01/2022 least 39C, please contact: this was! Rna ( mRNA ) Nucleoside-modified mRNA encoding the viral spike ( s glycoprotein. May temporarily reduce your ability to drive and use machines are protected from the virus SARS-CoV-2... Contact: this leaflet was last revised on 26/01/2022 data on the label after EXP date no. Given this COVID-19 vaccine AstraZeneca after the expiry date which is stated on the of! Help deliver the mRNA to the vaccine many areas of the Moderna vaccine include: ( SM-102, 0000102152... By other sites to help us deliver content from their services administration, pre-loading of is... Given the vaccine in the Johnson & amp ; the expiry date which is stated on the performance the. That severe and moderately immunocompromised persons should be offered an additional dose of.! Use cookies set by other sites to help us deliver content from services...

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