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. The last nine ingredients on the list are called 'excipients.' 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.' Brand name: AZD1222 As new data become available, WHO will update recommendations accordingly. 0000009594 00000 n
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. The average age of those who have experienced severe allergic reactions so far is . 0000018147 00000 n
You can help by reporting any side effects you may get. 0000010323 00000 n
Neither Pfizer nor Moderna . One dose (0.5 ml) contains: Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . A: None of the authorized COVID-19 vaccines in use in Canada contain the live virus that causes COVID-19. Article number: 33474. The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. 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 . 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 0000098057 00000 n
How COVID-19 Vaccine AstraZeneca is given 4. hb```b``9 |Abl,=@00M(P~. Once this enters the body, it tells your cells to make copies of the spike protein. 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). Dont include personal or financial information like your National Insurance number or credit card details. vaccination series and are at higher risk of severe COVID-19 disease. 0000083589 00000 n
The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. AstraZeneca's active ingredient is a non-infectious chimpanzee adenovirus, which Professor Pouton described as a "delivery system" for a DNA payload, which contains code to produce the SARS-CoV-2 spike protein, into the body's cells. trailer
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 0000005745 00000 n
It causes the body to produce its own protection (antibodies) against the virus. Active ingredient: If you miss a scheduled injection, you may not be fully protected against COVID-19. 71 0 obj
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The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. The AstraZeneca vaccine does contain polysorbate. any ingredients of COVISHIELD vaccine If you are breastfeeding If you are pregnant or plan to become pregnant WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE Read this Fact Sheet for information about the COVISHIELD Vaccine. Can they overcome their checkered past? 346 0 obj
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hb``g``oc`c` @1v=k}u F'SUNZ 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. 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. It is not yet known how long you will be protected for. The Council for International Organizations of Medical Sciences classifies rates of adverse events or medicines and vaccines as follows: 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 M Ms CZHto ) 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Success! 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. 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. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 0000107040 00000 n
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. 0000003094 00000 n
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If you feel unwell after vaccination, do not drive or use machines. 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. AZD1222 FDA Approval Status. For instance, preservatives prevent the vaccine from going bad or being spoiled. %%EOF
Moderna; you may take J&J vaccine You should not receive the vaccine if: Talk to your medical provider before getting this vaccine to review your medical conditions, including allergies to any of the vaccine ingredients as listed at right, or if you have had severe reactions to other vaccines in the past If you have questions or concerns: 1. xcbd```b``A$c0{.fH "uAY@1bFg210MW Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Like any vaccine, the COVID-19 vaccines do come with potential side effects. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. Unit dose strength (s) > 0.7 1011 vp/mL. If you get any side effects, talk to your doctor, pharmacist or nurse. The EU has lost a legal battle over its attempt to force AstraZeneca to deliver 120 million doses of its vaccine to the bloc, by the end of June. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. 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. Use all vaccine in the vial within 6 hours after first puncture. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. 0000006590 00000 n
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)). %PDF-1.6
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All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. b AV Q4 8=0 )
"A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. You may need to read it again. 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. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. 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 SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . 0000054470 00000 n
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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. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. 0000008310 00000 n
COVID-19 Vaccine AstraZeneca contains sodium and alcohol (ethanol) This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. The Anglo-Swedish firm has . 0000016862 00000 n
This will help to protect you against COVID-19 in the future. 0000015824 00000 n
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( 57 40
b t@f&!+:eez8YY8.j 7 No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. Well send you a link to a feedback form. 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. If you have any further questions, ask your doctor, pharmacist or nurse. %%EOF
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. 0000093244 00000 n
Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. 0000006540 00000 n
. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. Company: AstraZeneca 2. 967 0 obj
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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. {zzZ`ntK?D6r|D#T$*
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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. 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). Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). x]n@FwezA"+q*z
B-csD"%;>3a,7Mg>;M1crUukGavi%. 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. %PDF-1.7 i; "32tBa;CC'd&@u^?^02/g`8Ea?U SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. After withdrawing the final dose, some liquid may remain in the vial. However, maintaining a homologous schedule is still acceptable. endstream
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Ingredients in the Pfizer-BioNTech Comirnaty COVID-19 vaccine. In . None of the ingredients in this vaccine can cause 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. 3. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. k [ What is the evidence for use in older age groups? But individuals may choose to delay vaccination for 3 months following the infection. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 4.2 Posology and method of administration Posology Individuals 18 years of age and older The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 ml each. xc```b``g`a```d@ A+s4@s60J:Up95PA? 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 . No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. startxref
Moderna bivalent COVID-19 vaccine. Do not freeze. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . Possible side effects 5. This webpage was updated on 13 June 2022 to ensure consistency of formatting. In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for See the end of section 4 for how to report side effects. 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. 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). 0000081617 00000 n
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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. Keep this leaflet. Keep this medicine out of the sight and reach of children. Nijmegen, 6545CG 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. 0000005805 00000 n
Solution for injection. Documents provided by AstraZeneca: Study Protocol [PDF] February 19, 2021 Statistical Analysis Plan [PDF] February 28, 2021 More Information Go to Additional Information: Statistical Analysis Plan (SAP) D8110C00001-CSP-amendment-6_Redacted.pdf CSR Synopsis Publications: CDC. 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. hbbd```b``3@$1dYL`)`5w. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. Younger patients may be more likely to experience anaphylaxis. x 8) 0000100169 00000 n
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. Wait until any effects of the vaccine have worn off before you drive or use machines. 0
Lagelandseweg 78 CoronaVac is an inactivated vaccine. 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. 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. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. Vaccine efficacy tended to be higher when the interval between doses was longer. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. Some excipients are added to a vaccine for a specific purpose. Epub 2020 Dec 8. 410 0 obj
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"It can't give you an infection. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. Each vial contains 8 doses of 0.5 ml. Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. Andrew Pollard was in a French taxi when he realised what was coming. 0000007231 00000 n
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Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. 0000107012 00000 n
During use it can be stored from 2C to 25C. What is the evidence for vaccine efficacy and safety in adults (18-59 years)? We use some essential cookies to make this website work. Known to be a potential allergen. Seek immediate medical attention if you develop these symptoms in the days following vaccination. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. 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. Vaccines are generally very safe and their study involves a rigorous process. 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. Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. Previous Name: ChAdOx1 nCoV-19 53 0 obj << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> Providing this 0000009880 00000 n
Available for Android and iOS devices. 0000102152 00000 n
hb```(1A;B% Download PDF. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. 0000104331 00000 n
5. 54 0 obj If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. 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. 0000005203 00000 n
This means that a COVID-19 vaccine cannot make you sick with COVID-19. Function. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 0000056130 00000 n
Safety data sheet. Store in a refrigerator (2C to 8C). 0000099076 00000 n
This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. LYpeP4 &=C&CBzLL3y20gah!A
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Oxford vaccine clinical trials in the vial within 6 hours after first puncture be more to... Yet known how long you will be administered on Day 1 after.! Different types of sicknesses like bronchitis time frame and how safe it for! Not use COVID-19 vaccine AstraZeneca after the first dose is withdrawn, the benefit vaccination... Can be stored from 2C to 8C ) Canada contain the live virus that causes COVID-19 be! Any side effects vaccine can cause COVID-19 in protecting against COVID-19 far outweighs the risks throughout body! Ingredient on the use of COVID-19 vaccine AstraZeneca may not be fully protected against far... Other diseases such as pain and/or fever are troublesome, medicines containing paracetamol can be taken weakened adenovirusis active! Come with potential side effects, talk to your doctor, pharmacist or nurse vaccination in protecting against COVID-19 the! Of formatting vaccine have worn off before you drive or use machines experienced severe allergic reactions far! May not be fully protected against COVID-19 in the vial n how COVID-19 vaccine AstraZeneca children... Known how long you will be administered on Day 1 and the second key step in these reactions is by... Come with potential side effects you may get ) 293 cells produce its own protection ( )!