0000015637 00000 n /Info 87 0 R An email has been sent to you to confirm your subscription. xcbd```b``A$c0{.fH "uAY@1bFg210MW 5. 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. endobj The expiry date refers to the last day of that month. The first ingredient on the listthe weakened adenovirusis the active ingredient in this vaccine. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. startxref %PDF-1.7 The AstraZeneca vaccine is made from an adenovirus that has been changed in the lab so it can't cause harm. 0000132021 00000 n As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. 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. Some cases were life-threatening or had a fatal outcome. 0000005203 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. brain, liver, bowel, spleen). s/s's?3on1;XX(@?<=f@(tv4;r% ~IX 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. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary 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. Vaccine AstraZeneca and those who received control. In countries with ongoing Excipients are the non-active ingredients that are added to the vaccine for a variety of reasons. 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 . 0000053643 00000 n 0000005556 00000 n Neither Pfizer nor Moderna . On his way to a meeting to present . 0000004587 00000 n Seek immediate medical attention if you develop these symptoms in the days following vaccination. 0000093171 00000 n These include: y AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19. If you have any further questions, ask your doctor, pharmacist or nurse. Some affected patients had a previous diagnosis of CLS. If you get any side effects, talk to your doctor, pharmacist or nurse. However, maintaining a homologous schedule is still acceptable. 0000104953 00000 n dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c .O8:g] l TB;]@< -ll`]@m EX 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). 54 0 obj 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. Treatment for: Prevention of COVID-19. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. . The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 0000103016 00000 n Success! Nijmegen, 6545CG ]0[ WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. %PDF-1.7 % After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. This includes any possible side effects not listed in this leaflet. 0000006503 00000 n Efficacy. 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). <]/Prev 553136>> 0000008003 00000 n 0 /Root 55 0 R Dont worry we wont send you spam or share your email address with anyone. If you miss a scheduled injection, you may not be fully protected against COVID-19. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. &Va(f+0&+FIcDHoL 0000004762 00000 n A new investigational treatment for COVID-19: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Here what's in the Pfizer and AstraZeneca jabs (. WHO recommends the use of the ChAdOx1-S [recombinant] COVID-19 vaccine in pregnant women only when the benefits of vaccination to the pregnant woman outweigh the potential risks. 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. 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)). You may access the guidance document here. LYpeP4 &=C&CBzLL3y20gah!A '1>ederj4+e@Zg Rc`TaPa`2R6r G2p T ____________________________________________________________________________________. - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. This means that a COVID-19 vaccine cannot make you sick with COVID-19. stream 6. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines. Updated on 13 June 2022 to ensure consistency of formatting. 0000005745 00000 n Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Talk to the healthcare provider if you have questions. Can they overcome their checkered past? impact. 18 June 2021. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Some of the information might be out of date or no longer relevant. . This explainer is more than 90 days old. 0000014217 00000 n A third injection may be given at least 8 weeks after the second injection if advised by your doctor. 2. 0000009880 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. 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. It should be noted that the full two For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . Explanation of ingredients: - mRNA: Like the Pfzer BioNTech vaccine, Moderna's also uses mRNA technology to build antibodies against COVID-19. Your immune cells then recognise the spike protein as a threat and begin building an immune response against it. Function. 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. You can help by reporting any side effects you may get. AZD1222 FDA Approval Status. People with a history of severe allergic reaction to any component of the vaccine should not take it. 0 0000000016 00000 n This will help to protect you against COVID-19 in the future. Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. . % How to store COVID-19 Vaccine AstraZeneca 6. 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. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. A court in Belgium . This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. It uses a chimpanzee adenovirus to carry spike proteins from the . 0000004761 00000 n 0000003890 00000 n Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. 0000024916 00000 n 0000009792 00000 n 0000015344 00000 n Published March 31, 2021 Updated Aug. 1, 2021. /Size 89 /Prev 149222 Such reactions may include a combination of any of the following symptoms: In clinical studies with the vaccine, fewer side effects were reported after the second dose and those that were reported were milder in nature when compared to after the first dose. 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. 870 0 obj <>stream The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. Once this enters the body, it tells your cells to make copies of the spike protein. Generic name: SARS-CoV-2 vaccine This means that it is essentially sodium-free. Do not freeze. 0000006680 00000 n 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. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. 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. Like any vaccine, the COVID-19 vaccines do come with potential side effects. WHO does not recommend discontinuing breastfeeding because of vaccination. 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. hb``g``oc`c` @1v=k}u F'SUNZ 346 0 obj <> endobj endstream endobj startxref Use all vaccine in the vial within 6 hours after first puncture. The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time. 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. . Wait until any effects of the vaccine have worn off before you drive or use machines. 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. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine. 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.' This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . Keep this leaflet. Discard the vial and do not combine residual vaccine from multiple vials. 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