astrazeneca vaccine ingredients pdf

Last updated by Judith Stewart, BPharm on Feb 15, 2021. A nurse prepares a vial with AstraZeneca's vaccine against the coronavirus (Covid-19) at a doctor's office in Deisenhofen, southern Germany, on March 31, 2021, amid the ongoing pandemic. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. 2. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. 346 0 obj <> endobj We comply with the HONcode standard for trustworthy health information. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 0000009283 00000 n Any unused vaccine or waste material should be disposed of in accordance with local requirements. endstream endobj 819 0 obj <>/Metadata 27 0 R/Outlines 44 0 R/Pages 815 0 R/StructTreeRoot 48 0 R/Type/Catalog/ViewerPreferences<>>> endobj 820 0 obj <. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . 0000001596 00000 n 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. United Kingdom, MedImmune Pharma B.V., Nijmegen endstream endobj startxref The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000081617 00000 n 0000009792 00000 n Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. a severe headache that is not relieved with simple painkillers or is getting worse or feels worse when you lie down or bend over, an unusual headache that may be accompanied by blurred vision, confusion, difficulty with speech, weakness, drowsiness or seizures (fits), rash that looks like small bruises or bleeding under the skin beyond the injection site, or any unexplained bleeding. If you feel unwell after vaccination, do not drive or use machines. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. 0000099076 00000 n xcbd```b``A$c0{.fH "uAY@1bFg210MW The shot gives the body instructions to create the spike protein from COVID-19 in its cells. 0000002960 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. on AstraZeneca COVID-19 vaccine for reports of very rare side effects. hb```(1A;B% . 0000100043 00000 n xref 0000015824 00000 n 0000006680 00000 n Neither Pfizer nor Moderna . 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. 53 0 obj Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 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. A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. 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. 18 June 2021. EDTA is not listed as an ingredient in the Johnson &. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. /Size 89 /Prev 149222 0000002028 00000 n 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. You can help by reporting any side effects you may get. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Like all medicines, this vaccine can cause side effects, although not everybody gets them. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M M Ms CZHto ) 818 0 obj <> endobj 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. 3. Contents of the pack and other information 1. 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 Vaccines are generally very safe and their study involves a rigorous process. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. How COVID-19 Vaccine AstraZeneca is given 4. 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 Additional Information If you have questions, visit the website or call the telephone number provided 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. An email has been sent to you to confirm your subscription. It is your choice to receive the COVISHIELD . endstream endobj 76 0 obj <> stream %%EOF brain, liver, bowel, spleen). [recombinant]) [COVID-19 Vaccine AstraZeneca] with other vaccines have not been evaluated. None of the ingredients in this vaccine can cause COVID-19. (see section 2. 0000001732 00000 n 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. 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 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. 0000053643 00000 n 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. 0000107012 00000 n The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. 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. 0000001605 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. endstream endobj startxref 0 %%EOF 72 0 obj <>>> endobj 95 0 obj <> stream November 2020 - Trial data dispute. Keep vials in outer carton to protect from light. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. 0000082759 00000 n 0000132090 00000 n 0000005203 00000 n 0000006393 00000 n 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. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. 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. Get urgent medical attention if you get symptoms of a severe allergic reaction. 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 AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. FDA Approved: No The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid ____________________________________________________________________________________. During use it can be stored from 2C to 25C. Store in a refrigerator (2C to 8C). hb``g``oc`c` @1v=k}u F'SUNZ %PDF-1.7 % The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. Company: AstraZeneca Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. 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. A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome (TTS), involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine. However, maintaining a homologous schedule is still acceptable. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Read all of this leaflet carefully before the vaccine is given because it contains important information for you. 0000024847 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. Something went wrong while submitting the form. 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). % Keep this medicine out of the sight and reach of children. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. k [ 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. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. 0000015344 00000 n On his way to a meeting to present . Previous Name: ChAdOx1 nCoV-19 0000005556 00000 n Here what's in the Pfizer and AstraZeneca jabs (. Keep this leaflet. hbbd```b``5d4d""A$a0DEE4$U0 Netherlands. Most people have been exposed to them in their lives. The manufacturer URL for this document will be provided once that is available. AstraZeneca vs. Sinovac side effects. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. vaccination series and are at higher risk of severe COVID-19 disease. When these blood clots do occur, they may be in unusual or atypical locations (e.g. Vaccine Excipient Summary Excipients Included in U.S. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/ ,6aYmk}*Oko8/q1(z h^ONc! 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. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. In . You will receive 2 injections. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca 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 this medicine contains a very small amount of alcohol ( 2 mg alcohol... 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