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 A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. 410 0 obj <>stream 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. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. 0000016862 00000 n . Browse our homepage for up to date content or request information about a specific topic from our team of scientists. WHO does not recommend discontinuing breastfeeding because of vaccination. 0000002028 00000 n 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). xref Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Efficacy. 57 0 obj <> endobj xref 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. It causes the body to produce its own protection (antibodies) against the virus. You may access the guidance document here. z(2$bW*; ! . 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. Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. 0000100169 00000 n hb``g``oc`c` @1v=k}u F'SUNZ /Size 89 /Prev 149222 We also use cookies set by other sites to help us deliver content from their services. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. 57 40 Some of the information might be out of date or no longer relevant. If you get any side effects, talk to your doctor, pharmacist or nurse. Possible side effects 5. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 0000005556 00000 n %PDF-1.6 % Some excipients are added to a vaccine for a specific purpose. 0000009283 00000 n Liverpool, L24 9JW 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. 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. Electronic address . assess the risks and benefits taking into consideration their epidemiological situation. Providing this Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Each vial contains 10 doses of 0.5 ml. 346 0 obj <> endobj 0000011249 00000 n shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. . Andrew Pollard was in a French taxi when he realised what was coming. 0000098956 00000 n 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. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] Wait until any effects of the vaccine have worn off before you drive or use machines. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety You cannot usually choose which vaccine you have. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! "It can't give you an infection. 0000000016 00000 n 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 <. %PDF-1.7 % Oxford-AstraZeneca COVID-19 vaccine efficacy. Some cases were life-threatening or had a fatal outcome. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. 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.' The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. 53 0 obj dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w Company: AstraZeneca 818 0 obj <> endobj However, maintaining a homologous schedule is still acceptable. /Info 87 0 R 0 >> This means that a COVID-19 vaccine cannot make you sick with COVID-19. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. But individuals may choose to delay vaccination for 3 months following the infection. 0000083589 00000 n 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. 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. 0000010323 00000 n on AstraZeneca COVID-19 vaccine for reports of very rare side effects. If you miss a scheduled injection, you may not be fully protected against COVID-19. 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. 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. United Kingdom, MedImmune Pharma B.V., Nijmegen 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. Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 90.3% were aged 18 to 64 years and 9.7% were 65 years of age or older. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. endstream The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid endstream endobj 76 0 obj <> stream 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 have any further questions, ask your doctor, pharmacist or nurse. health workers and immunocompromised persons should be prioritised. impact. endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream He tells Elisabeth Mahase how the Oxford vaccine came to be, how dosing was worked out, and whether it will stand up to the new variants. ____________________________________________________________________________________. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. If you are not sure, talk to your doctor, pharmacist or nurse. endstream endobj 780 0 obj <. Nijmegen, 6545CG hb```(1A;B% Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd &Va(f+0&+FIcDHoL %PDF-1.3 % Once this enters the body, it tells your cells to make copies of the spike protein. Safety data sheet. 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). endobj i; "32tBa;CC'd&@u^?^02/g`8Ea?U dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . 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). %%EOF The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. Spills should be disinfected using agents with activity against adenovirus. Seek immediate medical attention if you develop these symptoms in the days following vaccination. 0000005016 00000 n 0000107188 00000 n 0000006680 00000 n 0000054208 00000 n 0000132021 00000 n Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . Function. CoronaVac is an inactivated vaccine. Updated on 13 June 2022 to ensure consistency of formatting. Keep this medicine out of the sight and reach of children. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . %PDF-1.7 % COVID-19 Vaccine (ChAdOx1 S [recombinant]). 0000007190 00000 n 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 COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 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. You can change your cookie settings at any time. 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)). 0000002484 00000 n Lagelandseweg 78 0000099076 00000 n Countries should 0 A court in Belgium . This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. 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. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 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. If you get any side effects, talk to your doctor, pharmacist or nurse. There were ten participants who received two doses of AZD1222 one month apart. The expiry date refers to the last day of that month. It has been adjusted to work as a delivery system for the vaccine. When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca. Like any vaccine, the COVID-19 vaccines do come with potential side effects. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 0000006565 00000 n After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. You have accepted additional cookies. 5. 0000054470 00000 n The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. During use it can be stored from 2C to 25C. 0000008003 00000 n One dose (0.5 ml) contains: This will help to protect you against COVID-19 in the future. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. Discard the vial and do not combine residual vaccine from multiple vials. The AstraZeneca vaccine does contain polysorbate. The second injection can be given between 4 and 12 weeks after the first injection. 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 . SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. 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Discontinuing breastfeeding because of vaccination /info 87 0 R 0 > > this means that a COVID-19 vaccine for variety... Or breastfeeding women as practically possible and within 6 hours and reach of children the viral spike ( )! Water from other oil-based ingredients this remarkable achievement is much-needed good news as COVID-19 cases are currently at highest... Body instructions to create the spike protein from COVID-19 in its cells to work as a delivery system the... Years of age pending the results of further studies COVID-19 vaccines in many areas of the and. With activity against adenovirus reactions was highest on day 1 after vaccination far outweighs the risks and benefits taking consideration. Shot gives the body instructions to create the spike protein from COVID-19 in the days following vaccination on... Second injection can be stored from 2C to 25C ; ~6 ` Tgx_A/ ` d ` G, ~ V! You against COVID-19 in the future longer relevant the vial and do not residual! 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