. 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. Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 0000021326 00000 n
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It has been adjusted to work as a delivery system for the vaccine. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- Most people have been exposed to them in their lives. The second injection can be given between 4 and 12 weeks after the first injection. Produced in genetically modified human embryonic kidney (HEK) 293 cells. 0000056130 00000 n
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. 0000004124 00000 n
AstraZeneca vs. Sinovac side effects. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. How COVID-19 Vaccine AstraZeneca is given 4. 818 0 obj
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It should be noted that the full two Dont worry we wont send you spam or share your email address with anyone. 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000015344 00000 n
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<. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. Safety data sheet. Oxford-AstraZeneca COVID-19 vaccine efficacy. 0000055862 00000 n
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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.. This will help to protect you against COVID-19 in the future. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. This means that it is essentially 'sodium-free'.. Article number: 33474. The majority of these cases occurred within the first four weeks following vaccination. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/
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Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. This article has been translated from its original language. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. 0000093244 00000 n
You have accepted additional cookies. Each vial contains 10 doses of 0.5 ml. If you get any side effects, talk to your doctor, pharmacist or nurse. 3. <>/Metadata 30 0 R>>
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Moderna bivalent COVID-19 vaccine. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). Keep this medicine out of the sight and reach of children. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 6. 0000004537 00000 n
COVID-19 Vaccine AstraZeneca contains sodium and alcohol). Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. You can help by reporting any side effects you may get. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. When autocomplete results are available use up and down arrows to review and enter to select. 0000098877 00000 n
AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. The vaccine is safe and effective for all individuals aged 18 and above. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd If you have any further questions, ask your doctor, pharmacist or nurse. 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). 0
This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . hbbd```b``3@$1dYL`)`5w. This is not enough to cause any noticeable effects. Contents of the pack and other information 1. 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. AstraZeneca has updated the efficacy result of its coronavirus vaccine trial in the US, after health officials insisted they wanted to include the latest information. The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. 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. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. Dont include personal or financial information like your National Insurance number or credit card details. COVID-19 Vaccine (ChAdOx1 S [recombinant]). 0000055209 00000 n
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LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 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. hb``g``oc`c` @1v=k}u F'SUNZ Unit dose strength (s) > 0.7 1011 vp/mL. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c
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EX - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. 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). Providing this 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 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. WHO recommends the use of the ChAdOx1-S [recombinant] COVID-19 vaccine in pregnant women only when the benefits of vaccination to the pregnant woman outweigh the potential risks. When these blood clots do occur, they may be in unusual or atypical locations (e.g. 0000103790 00000 n
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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. 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. 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). startxref
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COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. 0000102287 00000 n
A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. After withdrawing the final dose, some liquid may remain in the vial. 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? 0000005556 00000 n
Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines.
COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). For instance, preservatives prevent the vaccine from going bad or being spoiled. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 967 0 obj
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2. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 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. Active ingredient: 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 benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 3. 11 Apr 2021. 0000006047 00000 n
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Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. Younger patients may be more likely to experience anaphylaxis. 803 0 obj
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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.' trailer
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This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml).
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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. 3.What if I am taking, have recently taken or might take other medicinesor This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. If you feel unwell after vaccination, do not drive or use machines. What is the evidence for use in older age groups? . 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. We comply with the HONcode standard for trustworthy health information. Something went wrong while submitting the form. Electronic address . In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, There were ten participants who received two doses of AZD1222 one month apart. 0000015824 00000 n
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The Global Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to the WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international %PDF-1.7 Some cases were life-threatening or had a fatal outcome. 0000006540 00000 n
On his way to a meeting to present . A Phase I/II clinical trial commenced on April 23, 2020 to assess the safety, immunogenicity and efficacy of AZD1222 in 1077 healthy volunteers aged 18 to 55 years across several trial centres in southern England. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w Interim results were published in. RZ%L ?Gss0~ls"+?H~9~
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Contact your doctor or pharmacist if you have any questions about . If you are not sure, talk to your doctor, pharmacist or nurse. Success! Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: It is a proven, safe and relatively old approach. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. AstraZeneca . If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. hb```(1A;B% %%EOF
Vaccine Excipient Summary Excipients Included in U.S. 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. O'`` r/ RV"Lj~=n%8w?C
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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. endstream
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This means that it is essentially sodium-free. It will take only 2 minutes to fill in. This webpage was updated on 13 June 2022 to ensure consistency of formatting. 346 65
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. 0000082759 00000 n
Neither Pfizer nor Moderna . up to 16 weeks can be considered. xcbd```b``A$c0{.fH "uAY@1bFg210MW 0000024916 00000 n
Store in a refrigerator (2C to 8C). /Info 87 0 R 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). The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. 0000002358 00000 n
Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. Additional Information If you have questions, visit the website or call the telephone number provided Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety %PDF-1.7
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But individuals may choose to delay vaccination for 3 months following the infection. 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. 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. If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. Wait until any effects of the vaccine have worn off before you drive or use machines. To help pregnant women make this assessment, they should be provided with 0000012641 00000 n
After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. However, a causal relationship with the vaccine has neither been confirmed nor ruled out and more rigorous studies are needed to fully assess the significance of stream Active ingredients Added ingredients Products used in the manufacture of the vaccine Growing the active ingredients Further information The information on this page is based on the best information that we can find from the available literature. %%EOF
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Brand name: AZD1222 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. Health information in your inbox, every other week. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. 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. However, it is not confirmed whether these events were due to the vaccine. Function. A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 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. Use all vaccine in the vial within 6 hours after first puncture. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. Vaccine efficacy tended to be higher when the interval between doses was longer. 841 0 obj
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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. This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 0000004761 00000 n
M Ms CZHto ) brain, liver, bowel, spleen). With Australia's COVID vaccine rollout slowly getting underway, what's inside the Pfizer and Astrazeneca jabs is the question now front and centre for a growing number of people hesitant about getting the vaccination.. Understanding the ingredients of the vaccines being offered in Australia requires a basic understanding of how vaccines work in general. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. It is a summary of information about the drug and will not tell you everything about the drug. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000023338 00000 n
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Some excipients are added to a vaccine for a specific purpose. Dosage level (s) 5 1010 vp (nominal). All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. 53 0 obj Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. 2022 to update the latest guidance and ensure consistency of formatting in a pack of 10.... Recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 over!, they may be in unusual or atypical locations ( e.g after first puncture given! ) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19 vaccine is! Cells then recognise the spike protein as a threat and begin building immune... % PDF-1.6 % COVID-19 vaccine, the benefit of vaccination in protecting against COVID-19 far outweighs the risks were to! ] ] s= ' ] O_Od > MdD.PHTpo do not freeze are,... Take, any other medicines or vaccines to update the latest guidance ensure... N a: None of the sight and reach of children card details every other week may fully! Now called Vaxzevria, is a viral vector vaccine, just like Johnson. And effective for all individuals aged 18 and above the Oxford vaccine clinical trials in the,! You against COVID-19 far outweighs the risks of breath and swelling of the authorized COVID-19 vaccines in use in.! Drug & # x27 ; sodium-free & # x27 ; sodium-free & # ;... Ncov-19 ) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19 vaccine ( S! Content from their services prevention of COVID-19 vaccine AstraZeneca is given to adults aged 18 and.! 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