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The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 0000098136 00000 n
k [ The manufacturer URL for this document will be provided once that is available. Any unused vaccine or waste material should be disposed of in accordance with local requirements. %PDF-1.7 It is designed for consumers and care givers. 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. 3. 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. 410 0 obj
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The AstraZeneca vaccine is based on time-tested technology that employs a harmless cold virus (called adenovirus) that has been genetically modified to stimulate an immune response against the coronavirus. 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. 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. hbbd``b` $HpXAv DL) Dont include personal or financial information like your National Insurance number or credit card details. ]0[ COVID-19 Vaccine (ChAdOx1 S [recombinant]). >> 0000005203 00000 n
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<. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). Health information in your inbox, every other week. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. 0000004124 00000 n
Published March 31, 2021 Updated Aug. 1, 2021. 0000012193 00000 n
Published: 2021-05-07. 0000003715 00000 n
hb```Y@(&(fL(aW$Xz$7 If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. Organization: Public Health Agency of Canada. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). 53 0 obj Side effects for many of the vaccines currently available for COVID-19 are similar, with injection site pain and soreness leading the most common reactions . 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). A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 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. 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. 0000085176 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. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. %PDF-1.7
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It's only capable of delivering the DNA," he said. x]n@FwezA"+q*z
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Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The last nine ingredients on the list are called 'excipients.' 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. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. 0000093171 00000 n
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This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 0000100043 00000 n
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AZD1222 FDA Approval Status. If you miss a scheduled injection, you may not be fully protected against COVID-19. 548 0 obj
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endstream News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. %PDF-1.3
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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 vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. If you have any further questions, ask your doctor, pharmacist or nurse. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. Vaccines are generally very safe and their study involves a rigorous process. Treatment for: Prevention of COVID-19. 0000006617 00000 n
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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. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. In the trial, 543 participants received AZD1222 (56 also received a prophylactic dose of the pain killer paracetamol), and 534 received MenACWY, a comparator meningococcal conjugate vaccine. 56 0 obj The shot gives the body instructions to create the spike protein from COVID-19 in its cells. EDTA is not listed as an ingredient in the Johnson &. When autocomplete results are available use up and down arrows to review and enter to select. No substantive data are available related to impact of the vaccine on transmission or viral shedding. Please reach out if you have any feedback on the translation. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. When these blood clots do occur, they may be in unusual or atypical locations (e.g. 0000055862 00000 n
Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. 0000098057 00000 n
% The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c
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AstraZeneca vs. Sinovac side effects. 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. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. 18 June 2021. If you are allergic to any of the active substances or any of the other ingredients listed in section 6. 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. b t@f&!+:eez8YY8.j 7 346 0 obj
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It has been adjusted to work as a delivery system for the vaccine. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. 0000098749 00000 n
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It uses a chimpanzee adenovirus to carry spike proteins from the . If you have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving the vaccine. 0000019840 00000 n
This includes any possible side effects not listed in this leaflet. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. The second injection can be given between 4 and 12 weeks after the first injection. Company: AstraZeneca Vaccine AstraZeneca and those who received control. 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. If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 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. This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. We comply with the HONcode standard for trustworthy health information. 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 . Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 0000097826 00000 n
Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. 0000000016 00000 n
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5. Store in a refrigerator (2C to 8C). COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male. x 8) hb```b``9 |Abl,=@00M(P~. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. 54 0 obj 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. 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)). Some of the information might be out of date or no longer relevant. 779 0 obj
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The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. Younger patients may be more likely to experience anaphylaxis. 0000107012 00000 n
Known to be a potential allergen. 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. An email has been sent to you to confirm your subscription. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). Some cases had a fatal outcome. Success! . Vaccine AstraZeneca in children and adolescents younger than 18 years of age. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19.
To help pregnant women make this assessment, they should be provided with Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 841 0 obj
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Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. stream 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. This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. 0000024916 00000 n
serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. 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). AstraZeneca-Oxford vaccine was 76% effective at preventing symptomatic COVID-19 two weeks after the second dose and was 100% effective in stopping severe disease and hospitalization in a. Efficacy. Vaccine efficacy tended to be higher when the interval between doses was longer. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. Contact your doctor or pharmacist if you have any questions about . endstream
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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. 0000012641 00000 n
AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. %%EOF
At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. 6 Renaissance Way Epub 2020 Dec 8. The solution is colourless to slightly brown, clear to slightly opaque. Solution for injection. {zzZ`ntK?D6r|D#T$*
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However, maintaining a homologous schedule is still acceptable. 346 65
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You have accepted additional cookies. A court in Belgium . Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. Getty Images. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . The expiry date refers to the last day of that month. 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. these events. 0000003743 00000 n
However, it is not confirmed whether these events were due to the vaccine. 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 For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 2. 0000006393 00000 n
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Seek immediate medical attention if you develop these symptoms in the days following vaccination. /Info 87 0 R 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. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M
You cannot usually choose which vaccine you have. You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. 0000106271 00000 n
Cayman Chemical. 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. The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. FDA Approved: No WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 569 0 obj
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Unit dose strength (s) > 0.7 1011 vp/mL. 0000104331 00000 n
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stream If you are immunocompromised and receive a third dose of COVID-19 Vaccine AstraZeneca, it may still not provide full immunity to COVID-19 and you should continue to maintain physical precautions to help prevent COVID-19. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. 0000099076 00000 n
WHO does not recommend pregnancy testing prior to vaccination. Vaccine efficacy tended to be higher when the interval between doses was longer. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. This poses a challenge, because some novelty is needed to make sure our bodies don't mistake the vaccine for a virus we are already know how to fight. Updated on 13 June 2022 to ensure consistency of formatting. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. endstream
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stream vaccination series and are at higher risk of severe COVID-19 disease. But individuals may choose to delay vaccination for 3 months following the infection. 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). Spills should be disinfected using agents with activity against adenovirus. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 0000004240 00000 n
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Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). <>stream
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Well send you a link to a feedback form. 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.' LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 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. 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). - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 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. brain, liver, bowel, spleen). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 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. 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. Contents of the pack and other information 1. In . 0000001732 00000 n
hb``g``oc`c` @1v=k}u F'SUNZ 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). 0000015573 00000 n
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