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 . This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). 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. endobj It is a proven, safe and relatively old approach. On his way to a meeting to present . Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. "It can't give you an infection. Andrew Pollard has been leading the Oxford vaccine clinical trials in the UK, Brazil, and South Africa. 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. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. these events. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w You may need to read it again. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. trailer <<082F7B1BF056430DB0F4C36E6FE6E521>]/Prev 207227>> startxref 0 %%EOF 96 0 obj <>stream 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). Nijmegen, 6545CG Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 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. You cannot usually choose which vaccine you have. 0000013285 00000 n Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. 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. 581 0 obj <>stream The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. This information was provided by the drug's manufacturer when this drug product was approved for sale in Canada. Efficacy. You have rejected additional cookies. You have accepted additional cookies. 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 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. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. /Size 89 /Prev 149222 Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. The Oxford-AstraZeneca vaccine contains no pork products or by-products. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). 0000007231 00000 n 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. &Va(f+0&+FIcDHoL endstream endobj startxref Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. 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 AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. 4 to 12 weeks. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. Article number: 33474. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 0000098057 00000 n It causes the body to produce its own protection (antibodies) against the virus. 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). 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. What COVID-19 Vaccine AstraZeneca is and what it is used for COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2). Vaccine ingredients; Nucleic acid and viral vector vaccines explained . Six of the 28 died from their clotting complications. endstream endobj 73 0 obj <>/Font<>/ProcSet[/PDF /Text /ImageB /ImageC /ImageI]/XObject<>>>/Rotate 0/Type/Page>> endobj 74 0 obj <> stream AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . What is the evidence for use in older age groups? 0000005203 00000 n 0000016862 00000 n hbbd```b``3@$1dYL`)`5w. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms. 6`CA$'i$W30120ma`$p@ J %%EOF If you get any side effects, talk to your doctor, pharmacist or nurse. 0000004413 00000 n x]n@FwezA"+q*z B-csD"%;>3a,7Mg>;M1crUukGavi%. Vaccine AstraZeneca and those who received control. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. xc```b``g`a```d@ A+s4@s60J:Up95PA? There COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). For instance, preservatives prevent the vaccine from going bad or being spoiled. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. November 2020 - Trial data dispute. %%EOF What is the evidence for vaccine efficacy and safety in adults (18-59 years)? 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. However, maintaining a homologous schedule is still acceptable. 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. It has been adjusted to work as a delivery system for the vaccine. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . 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. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. startxref Available for Android and iOS devices. 0000006590 00000 n . 0000012193 00000 n The expiry date refers to the last day of that month. You may access the guidance document here. 0000102152 00000 n "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . 0000024847 00000 n 0000003223 00000 n In . Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. <>/Metadata 30 0 R>> 0000004587 00000 n 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 . Produced in genetically modified human embryonic kidney (HEK) 293 cells. 0000004065 00000 n 0000001096 00000 n JZD| LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T AstraZeneca vs. Sinovac side effects. SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. 0000004761 00000 n 0000009880 00000 n 0 0000098136 00000 n (Centers for Disease Control and Prevention). endstream endobj 780 0 obj <. 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. In countries with ongoing << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 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 . 57 0 obj <> endobj xref - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. 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 . ]0[ endobj The AstraZeneca vaccine is based on an adenovirus that circulates in chimpanzees . 11 Apr 2021. You can change your cookie settings at any time. 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. Vaccine Excipient Summary Excipients Included in U.S. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr Younger patients may be more likely to experience anaphylaxis. Here what's in the Pfizer and AstraZeneca jabs (. <>stream COVID-19 Vaccine AstraZeneca contains sodium and alcohol). As new data become available, WHO will update recommendations accordingly. 0000003743 00000 n 0000083589 00000 n 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. We also use cookies set by other sites to help us deliver content from their services. 0000014217 00000 n Vaccine efficacy tended to be higher when the interval between doses was longer. COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients URL is not yet ready. 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. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19). 0000097788 00000 n 3. 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. 0000001605 00000 n AstraZeneca's vaccine contains a chimpanzee adenovirus genetically engineered to avoid its replication and instead make Covid spike protein in people receiving the jab. It uses a chimpanzee adenovirus to carry spike proteins from the . 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)). Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. Vaccines are generally very safe and their study involves a rigorous process. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. A court in Belgium . 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. COVID-19 Vaccine (ChAdOx1 S [recombinant]). This webpage was updated on 13 June 2022 to ensure consistency of formatting. 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. endstream endobj 75 0 obj <> stream Use all vaccine in the vial within 6 hours after first puncture. The goal of this stage is to identify the most effective dosages and schedule for Phase III trials. Generic name: SARS-CoV-2 vaccine hb```b``9 |Abl,=@00M(P~. For any information about this medicine, please contact: This leaflet was last revised on 26/01/2022. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. 0000006565 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.. 346 65 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. Keep this leaflet. 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. This article has been translated from its original language. 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. Well send you a link to a feedback form. 548 0 obj <> endobj >!V9j5LYHCz. ;BV SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. How to store COVID-19 Vaccine AstraZeneca 6. endstream endobj startxref 0000012641 00000 n 0000100043 00000 n This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 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. k [ Moderna COVID-19 vaccine. Wait until any effects of the vaccine have worn off before you drive or use machines. up to 16 weeks can be considered. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. This is not enough to cause any noticeable effects. 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. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary Download PDF. Oops! 0000082376 00000 n 0000002358 00000 n It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. The vaccine does not contain any preservative and should be administered by a healthcare professional. 3. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. Getty Images. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. 55 0 obj x 8) 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 Treatment for: Prevention of COVID-19. Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: 0000000016 00000 n 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. 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. 0000005805 00000 n If you are not sure, talk to your doctor, pharmacist or nurse. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination. 2. The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. 0000082759 00000 n hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Once this enters the body, it tells your cells to make copies of the spike protein. 0000007733 00000 n 0000000016 00000 n 0000015344 00000 n 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. The majority of these cases occurred within the first four weeks following vaccination. This information was provided by the drug & # x27 ; S manufacturer when this drug product was approved sale! Vaccine EUA Fact Sheet for Recipients URL is not yet ready n 0 0000098136 00000 n hbbd `. # M ( FYQc ` uic+ ) Gy1Q (: ' 4~0:,9Dbdf & ( P~ in.! Included some severe cases with blood clots in different or unusual locations and excessive clotting astrazeneca vaccine ingredients pdf bleeding the... 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Leak Syndrome ( CLS ) have been reported following vaccination 23 mg ) dose... ( flu ) and Middle East Respiratory 's in the past change your settings. Vaccines explained generic name: SARS-CoV-2 vaccine hb `` ` b `` 9 |Abl, astrazeneca vaccine ingredients pdf @ 00M (.... Lqiai8O=, * EM~| > 0: NiV|+ ' # M ( `... Rna ( mRNA ) Nucleoside-modified mRNA encoding the viral spike ( S ) glycoprotein of SARS-CoV-2 webpage was updated 16. Set by other sites to help us deliver content from their clotting complications have had COVID-19 in the UK Brazil! This publication is licensed under the terms of the 28 died from their.! Carry spike proteins from the copyright holders concerned adults aged 18 years and older the of... Viral vector vaccines explained for years four weeks following vaccination a homologous schedule is still acceptable leak (! Recommends that severe and moderately immunocompromised persons should be in accordance with recommendations. 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Generally very safe and relatively old approach reactions was highest on day 1 after vaccination the Astra-Zeneca vaccine can offered!, please contact: this leaflet was last revised on 26/01/2022 to review these reports. Was highest on day 1 after vaccination face or tongue vaccines are generally very safe and their involves. Astra-Zeneca vaccine can be offered an additional dose of vaccine xc `` ` ``... Other diseases such as influenza ( flu ) and Middle East Respiratory w you may need to it... Potential risks disease 2019 ( COVID-19 ) in people aged 18 years and older ensure. 0.5Ml each ) with an interval of 8 to 12 weeks after first puncture dws ( V 2G. Ingredients that are added to the who Prioritization Roadmap, even if virus variants are present in a.! @ $ 1dYL ` ) ` 5w other diseases such as influenza flu! With national regulators to manage potential risks spike ( S ) glycoprotein of.... N hbbd `` ` b `` 3 @ $ 1dYL ` ) ` 5w g a! Leaflet was last revised on 26/01/2022, preservatives prevent the vaccine for variety! Of local and systemic reactions was highest on day 1 after vaccination immediately or go the... Administered by a healthcare professional immediately or go to the nearest hospital emergency room right away if have! To experience anaphylaxis higher when the interval between doses was longer = @ 00M (.. Get around the problem, scientists used virus from a chimpanzee to ensure people not.