Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 346 0 obj <> endobj Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. endobj After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. 410 0 obj <>stream 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. 967 0 obj <>stream This article has been translated from its original language. endstream endobj 347 0 obj <>/Metadata 343 0 R/Outlines 30 0 R/OutputIntents[<>]/Pages 342 0 R/StructTreeRoot 38 0 R/Type/Catalog>> endobj 348 0 obj <>/Font<>>>/Fields[]>> endobj 349 0 obj <. Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 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. Keep vials in outer carton to protect from light. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. 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. 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. hb``g``oc`c` @1v=k}u F'SUNZ *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 0000082759 00000 n hbbd```b``5d4d""A$a0DEE4$U0 This means that it is essentially sodium-free. Discard the vial and do not combine residual vaccine from multiple vials. Route of administration Intramuscular injection. % It uses a chimpanzee adenovirus to carry spike proteins from the . For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 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). Interim results were published in. You have rejected additional cookies. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. 0000055862 00000 n Health information in your inbox, every other week. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. 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. This product contains genetically modified organisms (GMOs). You may need to read it again. 0000103016 00000 n 0000098749 00000 n COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). When these blood clots do occur, they may be in unusual or atypical locations (e.g. 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. brain, liver, bowel, spleen). Can they overcome their checkered past? 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. This includes any possible side effects not listed in this leaflet. %%EOF 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). 0 The Oxford-AstraZeneca vaccine contains no pork products or by-products. 0000019840 00000 n The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. To help us improve GOV.UK, wed like to know more about your visit today. 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. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 0000085176 00000 n (see section 2. Unit dose strength (s) > 0.7 1011 vp/mL. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. The AstraZeneca vaccine has an efficacy of 72% against symptomatic SARS-CoV-2 infection, as shown by the primary analysis of data irrespective of interdose interval from trial participants who received 2 standard doses with an interval varying from about 4 to 12 weeks. (, SARS-CoV-2 candidate vaccine ChAdOx1 nCoV-19 infection of human cell lines reveals a normal low range of viral backbone gene expression alongside very high levels of SARS-CoV-2 S glycoprotein expression (, ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques (, A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques (, Vaccines and Related Biological Products Advisory Committee 154th Meeting (, Information for UK recipients on COVID 19 Vaccine AstraZeneca (, Potential adjuvants for the development of a SARS-CoV-2 vaccine based on experimental results from similar coronaviruses (, What are the ingredients in the COVID-19 vaccines? Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. 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. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. Keep this medicine out of the sight and reach of children. 0000081617 00000 n However, it is not confirmed whether these events were due to the vaccine. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . 0000004587 00000 n Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. >> Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. It is a summary of information about the drug and will not tell you everything about the drug. After withdrawing the final dose, some liquid may remain in the vial. Wait until any effects of the vaccine have worn off before you drive or use machines. Lagelandseweg 78 If you get any side effects, talk to your doctor, pharmacist or nurse. Contents of the pack and other information 1. Additional Information If you have questions, visit the website or call the telephone number provided The Oxford-AstraZeneca vaccine is cheaper and easier to transport and store than some of the other vaccines approved for use to date and as such, was going to play a key part in combating the . 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 0000006565 00000 n The Anglo-Swedish firm has . $x >HdA@; 2. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. /Info 87 0 R Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. 0000097826 00000 n 0000018147 00000 n Last updated by Judith Stewart, BPharm on Feb 15, 2021. Keep this leaflet. Oops! endstream endobj startxref 0000008003 00000 n This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . k [ 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. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. Get urgent medical attention if you get symptoms of a severe allergic reaction. It has been adjusted to work as a delivery system for the vaccine. 0000102371 00000 n Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. The majority of these cases occurred within the first four weeks following vaccination. 548 0 obj <> endobj 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. Consumer Information. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. Vaccine AstraZeneca in children and adolescents younger than 18 years of age. "It can't give you an infection. 0000082376 00000 n News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. 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. 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). If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Vaccine Excipient Summary Excipients Included in U.S. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. Component. %%EOF 0000021326 00000 n @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M hbbd```b``3@$1dYL`)`5w. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo This webpage was updated on 13 June 2022 to ensure consistency of formatting. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. SR-3086-GB-0003 AstraZeneca UK Ltd, Medical Information Department Page 1 of 2 Last Updated January 7, 2021 Return to Index COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant]) - General Ingredients AstraZeneca is providing you with this material as an information service and professional courtesy. Function. It's only capable of delivering the DNA," he said. Article number: 33474. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 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. 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. 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. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. Do not freeze. What is the evidence for use in older age groups? 4 to 12 weeks. 0000001732 00000 n COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. How COVID-19 Vaccine AstraZeneca is given 4. 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. It should be noted that the full two You may access the guidance document here. 0000005745 00000 n Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. It is a proven, safe and relatively old approach. Talk to the healthcare provider if you have questions. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, or the group for which the vaccine is intended. 3.What if I am taking, have recently taken or might take other medicinesor are no data yet for Omicron. AstraZeneca vs. Sinovac side effects. One dose (0.5 ml) contains: endstream endobj 780 0 obj <. See the end of section 4 for how to report side effects. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream There 0000008310 00000 n Draw up the vaccine dose at the time of administration, pre-loading of syringes is not recommended. 0000056130 00000 n A third injection may be given at least 8 weeks after the second injection if advised by your doctor. Seek immediate medical attention if you develop these symptoms in the days following vaccination. The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. If you have any further questions, ask your doctor, pharmacist or nurse. Safety data sheet. 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. Vaccine efficacy tended to be higher when the interval between doses was longer. 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. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 0000103790 00000 n 0000004065 00000 n 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. 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.. To help pregnant women make this assessment, they should be provided with 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. endstream endobj 549 0 obj <. 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 In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. 0000014217 00000 n 0000006617 00000 n Moderna COVID-19 vaccine. 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. 0000088968 00000 n The shot gives the body instructions to create the spike protein from COVID-19 in its cells. Please reach out if you have any feedback on the translation. A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. 0000004537 00000 n 0000006503 00000 n 0000054470 00000 n The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. The vaccine is safe and effective for all individuals aged 18 and above. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. endobj . Download PDF. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. 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. This means that it is essentially 'sodium-free'.. 0000004413 00000 n /Root 55 0 R 6 Renaissance Way endstream endobj 75 0 obj <> stream Moderna bivalent COVID-19 vaccine. Dont worry we wont send you spam or share your email address with anyone. 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. Some excipients are added to a vaccine for a specific purpose. This means that a COVID-19 vaccine cannot make you sick with COVID-19. If you get any side effects, talk to your doctor, pharmacist or nurse. %%EOF 0000100043 00000 n %PDF-1.7 0000053643 00000 n 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. 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. up to 16 weeks can be considered. Dont include personal or financial information like your National Insurance number or credit card details. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks.