Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- Contents of the pack and other information 1. None of the ingredients in this vaccine can cause COVID-19. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 0000002028 00000 n
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). shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. Epub 2020 Dec 8. The majority of these cases occurred within the first four weeks following vaccination. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. 0000056130 00000 n
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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. These ingredients range from forms of salt that help preserve the vaccine to water that dilutes it into the right concentration. You may need to read it again. If you get any side effects, talk to your doctor, pharmacist or nurse. Vaccine Excipient Summary Excipients Included in U.S. hb``g``oc`c` @1v=k}u F'SUNZ You have accepted additional cookies. 0000015344 00000 n
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If you have any further questions, ask your doctor, pharmacist or nurse. See section 4. Please reach out if you have any feedback on the translation. Last updated by Judith Stewart, BPharm on Feb 15, 2021. Vaccine efficacy tended to be higher when the interval between doses was longer. It causes the body to produce its own protection (antibodies) against the virus. How to store COVID-19 Vaccine AstraZeneca 6. %PDF-1.6
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If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca It is a summary of information about the drug and will not tell you everything about the drug. endstream
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<. 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. 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 dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. After withdrawing the final dose, some liquid may remain in the vial. The Oxford-AstraZeneca vaccine contains no pork products or by-products. JZD| This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. 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. 0000104331 00000 n
We comply with the HONcode standard for trustworthy health information. k [ Dosage level (s) 5 1010 vp (nominal). SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. 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. << /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 818 0 obj
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FDA Approved: No COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. To help us improve GOV.UK, wed like to know more about your visit today. 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). Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. endobj %PDF-1.7
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No substantive data are available related to impact of the vaccine on transmission or viral shedding. Vaccine efficacy tended to be higher when the interval between doses was longer. Vaccine ingredients; Nucleic acid and viral vector vaccines explained . Six of the 28 died from their clotting complications. 57 0 obj
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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? 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. 0000081617 00000 n
All 28 developed different types of clots, or thromboses, five to 16 days after vaccination, and all had made antibodies against platelets. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. &Va(f+0&+FIcDHoL Moderna COVID-19 vaccine. "Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . Interim results were published in. It is a proven, safe and relatively old approach. Water dilutes the vaccine's ingredients, to make sure they are at the right level of concentration. During the first stage (Phase I), the new vaccine is provided to small groups of peoplethe first time the vaccine is tested in humans. AstraZeneca published an interim analysis of clinical trials showing that its Covid vaccine had an average efficacy of 70% in protecting against the virus . As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. /Size 89 /Prev 149222 Unit dose strength (s) > 0.7 1011 vp/mL. AstraZeneca vs. Sinovac side effects. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. 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. hbbd```b``3@$1dYL`)`5w. To help pregnant women make this assessment, they should be provided with *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. 0000001096 00000 n
No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. 0000098877 00000 n
>> 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. 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. endstream
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Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. This is not enough to cause any noticeable effects. 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. The vaccine was administered as two doses of 5 x10 10 viral particles four weeks apart. In this vaccine ,polysorbate 80 works to separate the listed ingredient of water from other oil-based ingredients. This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. Neither Pfizer nor Moderna . 0000012641 00000 n
endstream It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. %PDF-1.3
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11 Apr 2021. O'`` r/ RV"Lj~=n%8w?C
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Each vial contains 10 doses of 0.5 ml. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 0000009792 00000 n
If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 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. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. Some cases were life-threatening or had a fatal outcome. 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. 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