The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid Published March 31, 2021 Updated Aug. 1, 2021. 0000107040 00000 n LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. 0000053643 00000 n . WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream If you are allergic to any of the active substances or any of the other ingredients listed in section 6. xVN@}W#E{I HTJB+!`)m;:KQyX99se The manufacturer URL for this document will be provided once that is available. An email has been sent to you to confirm your subscription. Produced in genetically modified human embryonic kidney (HEK) 293 cells. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr hbbd``b` $HpXAv DL) b t@f&!+:eez8YY8.j 7 0000098956 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 <. 0 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. AstraZeneca is a member of Covax, a global initiative aiming to distribute two billion vaccine doses to 92 low- and middle-income countries at no more than $3 a dose. 0000015637 00000 n z(2$bW*; ! Tell your doctor, pharmacist or nurse before vaccination: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine. 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. Company: AstraZeneca (, 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? 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. As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. EDTA is not listed as an ingredient in the Johnson &. Six of the 28 died from their clotting complications. The AstraZeneca vaccine does contain polysorbate. This is not enough to cause any noticeable effects. COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). Brand name: AZD1222 See section 4. Possible side effects 5. 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 0000009283 00000 n 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. It's only capable of delivering the DNA," he said. 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. Store in a refrigerator (2C to 8C). After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. 0000132021 00000 n 0000100043 00000 n "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. health workers and immunocompromised persons should be prioritised. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. 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. 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 0000002028 00000 n RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. 0000107012 00000 n WHO does not recommend pregnancy testing prior to vaccination. 410 0 obj <>stream This explainer is more than 90 days old. Information about the Moderna bivalent coronavirus vaccine, including vaccine ingredients, is available: Any unused vaccine or waste material should be disposed of in accordance with local requirements. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. %%EOF 53 0 obj 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. 0000001096 00000 n [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. ____________________________________________________________________________________. 0000102287 00000 n None of the ingredients in this vaccine can cause COVID-19. Can they overcome their checkered past? $x >HdA@; 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. 818 0 obj <> endobj AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. WHO does not recommend discontinuing breastfeeding because of vaccination. endstream endobj startxref CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 0000015573 00000 n Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj <>/Metadata 30 0 R>> You can change your cookie settings at any time. b AV Q4 8=0 ) In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. 0000088968 00000 n The vaccine is safe and effective for all individuals aged 18 and above. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. . on AstraZeneca COVID-19 vaccine for reports of very rare side effects. This includes any possible side effects not listed in this leaflet. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. hbbd```b``5d4d""A$a0DEE4$U0 As new data become available, WHO will update recommendations accordingly. Once approved, the drugmaker will work with national governments and international health organizations to monitor vaccine recipients for potential side effects from the vaccine that were not seen in clinical trials (this is called surveillance). The AstraZeneca vaccine has an efficacy of 72% against symptomatic SARS-CoV-2 infection, as shown by the primary analysis of data irrespective of interdose interval from trial participants who received 2 standard doses with an interval varying from about 4 to 12 weeks. 0000107188 00000 n Vaccine AstraZeneca in children and adolescents younger than 18 years of age. It is your choice to receive the COVISHIELD . >> hb```b``9 |Abl,=@00M(P~. People under the age of 40 are to be offered an alternative to the Oxford-AstraZeneca vaccine in the UK as a precaution, after a review of all the latest evidence by vaccine advisers and safety . 0 Published: 2021-05-07. xcbd```b``A$c0{.fH "uAY@1bFg210MW It will take only 2 minutes to fill in. 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. 0000102152 00000 n This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Netherlands. 0000055209 00000 n 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 remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. 0000055862 00000 n 0000004648 00000 n No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. 0000023338 00000 n 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. Cayman Chemical. 0000004065 00000 n Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety 0000083589 00000 n JZD| Do not freeze. 3. << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> To help pregnant women make this assessment, they should be provided with Younger patients may be more likely to experience anaphylaxis. , ,p 0000003715 00000 n The expiry date refers to the last day of that month. AZD1222 FDA Approval Status. Each vial contains 8 doses of 0.5 ml. 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. Additional Information If you have questions, visit the website or call the telephone number provided 0 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 . 0000006047 00000 n When these blood clots do occur, they may be in unusual or atypical locations (e.g. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w Vaccine Excipient Summary Excipients Included in U.S. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 0000003540 00000 n &Va(f+0&+FIcDHoL COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). these events. For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules: When considering booster vaccination after having been vaccinated with ChAdOx1-S [recombinant] COVID-19 [Astra Zeneca] vaccine for the primary series, SAGE considers using a different type of COVID-19 vaccine for a third dose a more favourable option. 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)). The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. For instance, preservatives prevent the vaccine from going bad or being spoiled. We comply with the HONcode standard for trustworthy health information. 0000106271 00000 n endstream Some cases were life-threatening or had a fatal outcome. Download PDF. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. Get urgent medical attention if you get symptoms of a severe allergic reaction. COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 0000005016 00000 n Electronic address . 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 Active ingredient: The second injection can be given between 4 and 12 weeks after the first injection. The overall safety of COVID-19 Vaccine AstraZeneca is based on an interim analysis of pooled data from four clinical trials conducted in the United Kingdom, Brazil, and South Africa. Solution for injection. Well send you a link to a feedback form. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . 0000011249 00000 n 0000001605 00000 n 0000003743 00000 n However, maintaining a homologous schedule is still acceptable. Oxford-AstraZeneca COVID-19 vaccine efficacy. endstream endobj startxref Use all vaccine in the vial within 6 hours after first puncture. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. 0000001732 00000 n Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. {zzZ`ntK?D6r|D#T$* TGBKz. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19. stream 0000004124 00000 n Keep this medicine out of the sight and reach of children. Each vial contains 10 doses of 0.5 ml. 0000081617 00000 n What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Last updated by Judith Stewart, BPharm on Feb 15, 2021. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca. This will help to protect you against COVID-19 in the future. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). 346 0 obj <> endobj %PDF-1.3 % This webpage was updated on 13 June 2022 to ensure consistency of formatting. 0000024847 00000 n Please reach out if you have any feedback on the translation. See the end of section 4 for how to report side effects. 6`CA$'i$W30120ma`$p@ J endobj endstream endobj 549 0 obj <. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. Generic name: SARS-CoV-2 vaccine 0000098749 00000 n 57 40 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. Consumer Information. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 10^10 viral particles (vp). hb```(1A;B% This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. 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. AstraZeneca . The majority of these cases occurred within the first four weeks following vaccination. Moderna COVID-19 vaccine. 581 0 obj <>stream 0000009594 00000 n It should be noted that the full two impact. 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. The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. Providing this x 8) Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. 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. 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. 0000002484 00000 n This article has been translated from its original language. syndrome [GBS]), rapid swelling under the skin in areas such as the face, lips, mouth and throat (which may cause difficulty in swallowing or breathing) (angioedema), capillary leak syndrome (a condition causing fluid leakage from small blood vessels), very low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, Blood disorders), blood clots in the brain, not associated with low level of blood platelets (see section 2, Blood disorders), inflammation of the spinal cord which may cause muscle weakness, localised or radiating back pain, bladder and bowel symptoms and changes in sensation (transverse myelitis). 3.What if I am taking, have recently taken or might take other medicinesor Vaccine efficacy tended to be higher when the interval between doses was longer. 0000093244 00000 n 0000098877 00000 n Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. /ID [<46442D36362D36432D33412D43412D36>] 0000103790 00000 n py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( 0000007231 00000 n You may need to read it again. x P^0^N&8:Cssfo"E$hq(#^G78@ 0000097788 00000 n If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. . 0000000016 00000 n 0000007190 00000 n trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream <>stream 0000012641 00000 n Seek immediate medical attention if you develop these symptoms in the days following vaccination. /Info 87 0 R A court in Belgium . 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