See the end of section 4 for how to report side effects. 0000004587 00000 n
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). Keep this medicine out of the sight and reach of children. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M
This means that it is essentially 'sodium-free'.. 0000004065 00000 n
impact. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. O'`` r/ RV"Lj~=n%8w?C
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6. A booster dose may be considered 4 6 months after completion of the primary vaccination series, starting with the higher priority-use groups, in accordance with the WHO Prioritization Roadmap. 0000103790 00000 n
Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. Well send you a link to a feedback form. 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. 410 0 obj
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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. 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. SAGE has reviewed all available data on the performance of the vaccine in the settings of variants of concern. 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 affected patients had a previous diagnosis of CLS. 55 0 obj Dosage level (s) 5 1010 vp (nominal). Company: AstraZeneca Get urgent medical attention if you get symptoms of a severe allergic reaction. Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. 0000006617 00000 n
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). People with a history of severe allergic reaction to any component of the vaccine should not take it. 0000025064 00000 n
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stream For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 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. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. 0000098057 00000 n
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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. 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. The Anglo-Swedish firm has . Lagelandseweg 78 There were ten participants who received two doses of AZD1222 one month apart. &Va(f+0&+FIcDHoL startxref
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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. Neither Pfizer nor Moderna . xcbd```b``A$c0{.fH "uAY@1bFg210MW endstream
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stream Safety data sheet. If you feel unwell after vaccination, do not drive or use machines. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. 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. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. << /Type /XRef /Filter /FlateDecode /Length 115 /W [ 1 3 1 ] /Index [ 53 36 ] 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. 6 Renaissance Way endobj Unit dose strength (s) > 0.7 1011 vp/mL. 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. COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. 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. Some cases had a fatal outcome. RZ%L ?Gss0~ls"+?H~9~
~~g5-?K~=2_H If you miss a scheduled injection, you may not be fully protected against COVID-19. /ID [<46442D36362D36432D33412D43412D36>] 0000004762 00000 n
Produced in genetically modified human embryonic kidney (HEK) 293 cells. 0000007733 00000 n
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Like all medicines, this vaccine can cause side effects, although not everybody gets them. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. The solution is colourless to slightly brown, clear to slightly opaque.
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. Any unused vaccine or waste material should be disposed of in accordance with local requirements. >> 0000018147 00000 n
on AstraZeneca COVID-19 vaccine for reports of very rare side effects. 0000006565 00000 n
$x >HdA@; Liverpool, L24 9JW /Root 55 0 R 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. xref
The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. It is designed for consumers and care givers. Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- 2. 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. Once this enters the body, it tells your cells to make copies of the spike protein. Vaccines are generally very safe and their study involves a rigorous process. The AstraZeneca vaccine does contain polysorbate. 0000103016 00000 n
The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. This includes any possible side effects not listed in this leaflet. This means that it is essentially sodium-free. The vaccine is safe and effective for all individuals aged 18 and above. up to 16 weeks can be considered. The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination.
Treatment for: Prevention of COVID-19. The shot gives the body instructions to create the spike protein from COVID-19 in its cells. 841 0 obj
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Vaccine efficacy tended to be higher when the interval between doses was longer. _:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj 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. 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)). 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. WHO does not recommend pregnancy testing prior to vaccination. SAGE currently recommends its use according to the WHO Prioritization Roadmap, even if virus variants are present in a country. AstraZeneca has updated the efficacy result of its coronavirus vaccine trial in the US, after health officials insisted they wanted to include the latest information. However, maintaining a homologous schedule is still acceptable. 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. 0000100169 00000 n
There By reporting side effects you can help provide more information on the safety of this vaccine. 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,. AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. 0000024847 00000 n
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COVID-19 Vaccine AstraZeneca contains sodium and alcohol). 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. Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . 0000008003 00000 n
It should be noted that the full two Contents of the pack and other information 1. AZD1222 FDA Approval Status. If you get any side effects, talk to your doctor, pharmacist or nurse. Use all vaccine in the vial within 6 hours after first puncture. Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose. 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). Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. Available for Android and iOS devices. This includes any possible side effects not listed in this leaflet. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. 0000021326 00000 n
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COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID 19, caused by a virus called coronavirus (SARS-CoV-2). 0000104331 00000 n
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. x]n@FwezA"+q*z
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