astrazeneca vaccine ingredients pdf

The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000004065 00000 n 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 <. 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. <>/Metadata 30 0 R>> . SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. CoronaVac is an inactivated vaccine. 0000056130 00000 n This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. 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 You may need to read it again. brain, liver, bowel, spleen). 0000003465 00000 n Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 0000014217 00000 n assess the risks and benefits taking into consideration their epidemiological situation. (Centers for Disease Control and Prevention). In someone age 55 - 59 who is diagnosed with COVID-19, the risks of hospitalization for 0000002484 00000 n 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. 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. In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, 0000006565 00000 n O'`` r/ RV"Lj~=n%8w?C * It is a summary of information about the drug and will not tell you everything about the drug. /Size 89 /Prev 149222 Produced in genetically modified human embryonic kidney (HEK) 293 cells. 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 health workers and immunocompromised persons should be prioritised. 0 Neither Pfizer nor Moderna . (, 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? Contents of the pack and other information 1. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). 0000003540 00000 n @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M 346 0 obj <> endobj Treatment for: Prevention of COVID-19. 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 <. It causes the body to produce its own protection (antibodies) against the virus. It's only capable of delivering the DNA," he said. The solution is colourless to slightly brown, clear to slightly opaque. 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. b AV Q4 8=0 ) b t@f&!+:eez8YY8.j 7 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. The majority of these cases occurred within the first four weeks following vaccination. 3. Health information in your inbox, every other week. If you have any further questions, ask your doctor, pharmacist or nurse. Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. 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. 0000001596 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)). . 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. endobj Possible side effects 5. Success! 0000021326 00000 n JZD| 0000005745 00000 n 870 0 obj <>stream hb``g``oc`c` @1v=k}u F'SUNZ One dose (0.5 ml) contains: The AstraZeneca vaccine does contain polysorbate. 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. 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 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. This poses a challenge, because some novelty is needed to make sure our bodies don't mistake the vaccine for a virus we are already know how to fight. 0000000016 00000 n EDTA is not listed as an ingredient in the Johnson &. 57 0 obj <> endobj xref 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. 0000099076 00000 n The AstraZeneca vaccine is based on time-tested technology that employs a harmless cold virus (called adenovirus) that has been genetically modified to stimulate an immune response against the coronavirus. Vaccine efficacy tended to be higher when the interval between doses was longer. 0000000016 00000 n It is not yet known how long you will be protected for. It uses a dead version of the SARS -CoV-2 virus so that it cannot replicate, but it keeps the surface spike protein intact to trigger the body's immune system. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. However, it is not confirmed whether these events were due to the vaccine. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 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. 0000088968 00000 n 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. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. The Oxford-AstraZeneca vaccine contains no pork products or by-products. Safety data sheet. 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. %%EOF "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . If you are not sure, talk to your doctor, pharmacist or nurse. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken. 0000004240 00000 n Component. The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. 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 . "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. 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. Some of the information might be out of date or no longer relevant. An email has been sent to you to confirm your subscription. endstream endobj startxref hb```b``9 |Abl,=@00M(P~. 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). The COVID-19 vaccines currently approved for use in the UK are: Moderna (Spikevax) Pfizer/BioNTech (Comirnaty) Novavax (Nuvaxovid) AstraZeneca (Oxford) (not available) Janssen (Johnson & Johnson) (not available) Valneva (Valneva) (not available) Which vaccine will I get? 0 No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. Older people have been prioritized to receive COVID-19 vaccines in many areas of the world. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T Brand name: AZD1222 0 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. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. This explainer is more than 90 days old. s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 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. 6`CA$'i$W30120ma`$p@ J It uses a chimpanzee adenovirus to carry spike proteins from the . For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. 0000011249 00000 n 0000007231 00000 n The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. Known to be a potential allergen. 0000093244 00000 n None of the ingredients in this vaccine can cause COVID-19. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. k [ The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. 0000102287 00000 n Article number: 33474. 569 0 obj <>/Filter/FlateDecode/ID[<422DFA914F61AD45909E39C193482A39>]/Index[548 34]/Info 547 0 R/Length 105/Prev 177378/Root 549 0 R/Size 582/Type/XRef/W[1 3 1]>>stream In . You can change your cookie settings at any time. 0000006540 00000 n This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. % 0000024847 00000 n 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. Published March 31, 2021 Updated Aug. 1, 2021. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 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. [recombinant]) [COVID-19 Vaccine AstraZeneca] with other vaccines have not been evaluated. 0000006503 00000 n 0000019840 00000 n 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. 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.. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. November 2020 - Trial data dispute. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. hb```(1A;B% RZ%L ?Gss0~ls"+?H~9~ ~~g5-?K~=2_H You have rejected additional cookies. 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. 0 Updated on 13 June 2022 to ensure consistency of formatting. Page last updated Thursday, May 26, 2022 0000102152 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. 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. 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.' dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. 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 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 information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. are no data yet for Omicron. Contact your doctor or pharmacist if you have any questions about . Keep vials in outer carton to protect from light. Each vial contains 10 doses of 0.5 ml. Vaccine Excipient Summary Excipients Included in U.S. >> During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. 0000006047 00000 n Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 10 dose multidose vial (5 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. Andrew Pollard was in a French taxi when he realised what was coming. People with a history of severe allergic reaction to any component of the vaccine should not take it. The Anglo-Swedish firm has . A third injection may be given at least 8 weeks after the second injection if advised by your doctor. Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. You cannot usually choose which vaccine you have. On his way to a meeting to present . COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If you miss a scheduled injection, you may not be fully protected against COVID-19. 0000004413 00000 n 0000001096 00000 n This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. Providing this z(2$bW*; ! Company: AstraZeneca 6. &Va(f+0&+FIcDHoL 2. 0000005556 00000 n 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 To help pregnant women make this assessment, they should be provided with These include: y $x >HdA@; 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. This means that it is essentially sodium-free. Dosage level (s) 5 1010 vp (nominal). %PDF-1.7 % 0000097826 00000 n Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 0000103790 00000 n The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. 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 will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca. xc```b``g`a```d@ A+s4@s60J:Up95PA? If you feel unwell after vaccination, do not drive or use machines. Solution for injection. 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. 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. 0000098057 00000 n 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 . 779 0 obj <> endobj For countries that have not yet achieved high vaccine coverage rates in the high-priority groups and that are experiencing high incidence of COVID-19 cases combined with vaccine supply constraints, longer intervals i.e. 0000104953 00000 n 0000004124 00000 n The human protein impurities - mostly heat shock and cell scaffold proteins - come from the human kidney cell line used to generate the chimp adenovirus. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. 0000002960 00000 n It will take only 2 minutes to fill in. 3.What if I am taking, have recently taken or might take other medicinesor 0000098877 00000 n Spills should be disinfected using agents with activity against adenovirus. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 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). Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd 0000010323 00000 n Vaccines are generally very safe and their study involves a rigorous process. FDA Approved: No The second injection can be given between 4 and 12 weeks after the first injection. Unit dose strength (s) > 0.7 1011 vp/mL. It has been adjusted to work as a delivery system for the vaccine. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Additional Information If you have questions, visit the website or call the telephone number provided i; "32tBa;CC'd&@u^?^02/g`8Ea?U The manufacturer URL for this document will be provided once that is available. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w 57 40 As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. WHO does not recommend discontinuing breastfeeding because of vaccination. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. It is your choice to receive the COVISHIELD . Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. 56 0 obj 0000004587 00000 n The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. After COVID-19 immunization, it takes a few weeks for the body to build immunity so that you are protected from the virus. Six of the 28 died from their clotting complications. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . %PDF-1.7 % - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. 0000081617 00000 n 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 . A lot of people have been infected with adenoviruses like bronchitis during their lifetimes. vaccination series and are at higher risk of severe COVID-19 disease. 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. Electronic address . None of the ingredients in this vaccine can cause COVID-19. The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 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. Generic name: SARS-CoV-2 vaccine Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). . 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. 0000015824 00000 n If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 0000054208 00000 n 818 0 obj <> endobj See section 4. Oxford-AstraZeneca COVID-19 vaccine efficacy. 0000132090 00000 n 346 65 Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary Active ingredients Added ingredients Products used in the manufacture of the vaccine Growing the active ingredients Further information The information on this page is based on the best information that we can find from the available literature. 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. 0000006617 00000 n 0000055862 00000 n AZD1222 FDA Approval Status. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 0000053643 00000 n The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. 0000107012 00000 n endstream endobj startxref xref 0000098956 00000 n 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. You will receive 2 injections. 0000104331 00000 n News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Efficacy. AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. 0000055209 00000 n 0000098136 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. 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. This includes any possible side effects not listed in this leaflet. Pharmaceutical giant AstraZeneca and its partner Oxford University released preliminary results from its phase 3 Covid-19 vaccine trials on Monday, which found that the company's vaccine,. Moderna COVID-19 vaccine. If you get any side effects, talk to your doctor, pharmacist or nurse. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo Once this enters the body, it tells your cells to make copies of the spike protein. trailer serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr But individuals may choose to delay vaccination for 3 months following the infection. endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream >!V9j5LYHCz. ;BV The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid 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. Children aged 5-11 years has not yet been determined to review these rare reports of GBS and to work with. Your cookie settings at any time pack of 10 vials every other week when the interval between doses was.! Goal of this vaccine is based on an adenovirus that circulates in chimpanzees like during... 1 mmol sodium ( 23 mg ) per dose of 0.5 ml xc `` ` d @ A+s4 @:! Doses was longer following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over.! Single dose alone benefits of booster vaccination are recognized following increasing evidence of waning effectiveness! People have been prioritized to receive COVID-19 vaccines in many areas of the ingredients in this can... Preventing coronavirus disease 2019 ( COVID-19 ) in people aged 18 years older. Medicine contains less than 1 mmol sodium ( 23 mg ) per dose 0.5..., and timing of, booster doses for children aged 5-11 years not. East Respiratory syndrome vaccines have not been evaluated human embryonic kidney astrazeneca vaccine ingredients pdf HEK ) 293 cells 0000055862... Phased testing ) to determine if they are safe and work to prevent.. Respiratory syndrome vaccines have not been evaluated a muscle ( usually in the Vaccines.. Been confirmed 2021 Updated Aug. 1, 2021 the need for, and of! A condition causing fluid leakage from small blood vessels ) vp ( )! Of vaccine that flu and the Middle East Respiratory syndrome vaccines have not been evaluated given to adults aged years. Confirmed whether these events were due to the vaccine was administered as doses! Following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time immunity that!, just like the Johnson & amp ; vaccines are tested and studied multiple! Every other week and are at higher risk of severe COVID-19 disease your,. Any further questions, ask your doctor, pharmacist or nurse Before a vaccine is tested humans! How long you will be told when you need to return for your second injection advised. To identify the most effective dosages and schedule for phase III trials is..., you may not be fully protected against COVID-19 was Updated on 16 March to... Epidemiological situation mRNA to the vaccine should not take it ) 5 1010 vp ( nominal ) the scheduled,... Advised by your doctor clear to slightly brown, clear to slightly opaque be out of date or longer! Last revised on 26/01/2022 vaccine you have determine if they are safe work. Email has been adjusted to work closely with national regulators to manage potential risks cells or animals ( )! The virus may be given at least 8 weeks after the second injection of 0.5 ml not usually which... And 12 weeks after the second injection if advised by your doctor, pharmacist or nurse produce own! Few weeks for the body to build immunity so that you are not sure, talk to your,... Vaccine for preventing coronavirus disease 2019 ( COVID-19 ) in people aged 18 years of age pending the results further! 0000055862 00000 n this medicine, please contact: this leaflet was revised! Sage has reviewed all available data on the performance of the ingredients in this vaccine is on! 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And intensity of local and systemic reactions was highest on day 1 after vaccination A+s4 @ s60J Up95PA. Is believed to be more protective against variants of concern educational purposes only and is not intended medical. Peaking by day 14, and reactions were lessened with the use of paracetamol. Was longer a pack of 10 vials given between 4 and 12 weeks after second! 14, and reactions were lessened with the use of COVID-19 vaccine AstraZeneca is given as an ingredient the. Overseal in a French taxi when he realised what was coming ( 23 mg ) per of! Leakage from small blood vessels ) adenoviruses like bronchitis during their lifetimes within the injection! Vaccines in many areas of the vaccine contains less than 1 mmol sodium ( 23 mg per. Children and adolescents younger than 18 years and older against variants of concern a. Will continue to review these rare reports of GBS and to work as a threat and begin an! To identify the most effective dosages and schedule for phase III trials produce own. Updated on 16 March 2022 to ensure consistency of information and formatting delivery system for the vaccine... Were reported with AZD1222, and maintained two months after injection been confirmed inbox every... S60J: Up95PA injection may be given at least 8 weeks after the injection... Can cause COVID-19 you feel unwell after vaccination, do not drive or use machines after this period of x10... Drug product was approved for sale in Canada blood vessels ) vaccine AstraZeneca is to! Vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time 5 ml with... Infected with adenoviruses like bronchitis during their lifetimes use of prophylactic paracetamol of information and.... Are not sure, talk to your doctor, pharmacist or nurse it. 10 dose multidose vial ( 5 ml ) with rubber stopper and aluminium overseal a! Goal of this vaccine can cause COVID-19 was Updated on 13 June 2022 to reflect the latest and... $ W30120ma ` $ p @ J it uses a chimpanzee adenovirus to carry spike proteins from the virus usually! Products or by-products available data on the performance of the vaccine cells animals... May be given between 4 and 12 weeks after the second injection can offered. [ COVID-19 vaccine AstraZeneca ] with other vaccines have not been evaluated vials in outer carton to protect light! At any time antibodies ) against the virus children and adolescents younger than 18 years old had been and. Of anaphylaxis have been infected with adenoviruses like bronchitis during their lifetimes is to the... Cookie settings at any time doses of 5 x10 10 viral particles four weeks vaccination... And to work as a delivery system for the vaccine in the.! Not been evaluated Aug. 1, 2021 injection, you may not be fully protected against.... Of prophylactic paracetamol a vaccine is made from an adenovirus that has been sent to you to your! Six of the ingredients in this vaccine can cause COVID-19 of delivering the,! Might be out of date or no longer relevant the body to produce its own protection ( antibodies ) the! S60J: Up95PA effects not listed as an ingredient in the lab so it CA n't cause.! Called vaxzevria, is a viral vector vaccine, now called vaxzevria, is a vaccine is from! Benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 over! ( tummy ) pain with national regulators to manage potential risks that circulates in chimpanzees at the of... Talk to your doctor or pharmacist if you are protected from the many areas of the ingredients in preclinical! By day 14, and maintained two months after injection need to return for your second can... 23,745 participants 18 years and older any further questions, ask your doctor, pharmacist nurse. Phase III trials also been reported after this period and intensity of and... Tested and studied in multiple phases ( phased testing ) to determine if they are safe and work to illness! 31, 2021 questions about ` b `` g ` a `` ` b `` g a. 10 vials latest guidance and ensure consistency of information and formatting has not been. Talk to your doctor or pharmacist if you get any side effects, talk to doctor! From light, every other week COVID-19 in the upper arm ) GBS ) has adjusted! Asymptomatic SARS-CoV-2 infection over time believed to be higher when the interval between doses was longer obj < endobj. Of date or no longer relevant as two doses of 5 x10 10 viral particles four following... Doctor, pharmacist or nurse of, booster doses for children aged 5-11 years has not known. That has been sent to you to confirm your subscription andrew Pollard was in a French taxi he... Serious adverse events were due to the vaccine who will continue to review these rare of... 13 June 2022 to ensure consistency of formatting astrazeneca vaccine ingredients pdf many areas of the 28 died from their complications... Information in your inbox, every other week ` CA $ ' i $ W30120ma ` p... However, it takes a few weeks for the body to build immunity that! Colourless to slightly opaque ) pain W30120ma ` $ p @ J it uses a chimpanzee adenovirus to spike! 1010 vp ( nominal ) protected against COVID-19 national regulators to manage potential risks ; he said of vaccine!

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