(Centers for Disease Control and Prevention). It is a proven, safe and relatively old approach. RZ%L ?Gss0~ls"+?H~9~
~~g5-?K~=2_H It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. Do not freeze. 0000104331 00000 n
The AstraZeneca vaccine is not a live virus vaccine, it is therefore biologically and clinically unlikely to pose a risk to the breastfeeding child. The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. This is the same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines have used for years. hbbd```b``3@$1dYL`)`5w. 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. Health information in your inbox, every other week. Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. 0000006393 00000 n
0000003465 00000 n
%%EOF
As new data become available, WHO will update recommendations accordingly. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. WASHINGTON Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago . Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: <]/Prev 553136>>
0000006617 00000 n
Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The manufacturer URL for this document will be provided once that is available. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. 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. When these blood clots do occur, they may be in unusual or atypical locations (e.g. impact. The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid 0000004159 00000 n
53 0 obj In line with the WHO Prioritization Roadmapand and the WHO Values Framework older adults, The shot gives the body instructions to create the spike protein from COVID-19 in its cells. This means that a COVID-19 vaccine cannot make you sick with COVID-19. 0000093244 00000 n
health workers and immunocompromised persons should be prioritised. shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. %%EOF
The recommended dosage is two doses given intramuscularly (0.5ml each) with an interval of 8 to 12 weeks. "It can't give you an infection. 0000107188 00000 n
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. These include: y x 8) 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. b AV Q4 8=0 )
endobj Of those who experienced fever, 18% reported temperatures of at least 38C, and 2% reported temperatures of at least 39C. Vaccine Maker Halts Trial Following Unexplained Illness in Volunteer, Details Emerge on Unexplained Illness in AstraZeneca COVID Vaccine Trial, A Study of a Candidate COVID-19 Vaccine (COV001), New Vaxzevria Data Further Support its Use as Third Dose Booster, Vaxzevria Significantly Boosted Antibody Levels Against Omicron, Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern, Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose, COVID-19 Vaccine AstraZeneca Effective Against Delta (Indian) Variant, AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan, AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy, AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis, UK and EU Regulatory Agencies Confirm COVID-19 Vaccine AstraZeneca is Safe and Effective, Update on the Safety of COVID-19 Vaccine AstraZeneca, AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX, AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization, COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials, COVID-19 Vaccine AstraZeneca Authorised for Use in the EU, COVID-19 Vaccine AstraZeneca Recommended for Use in the EU, Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZenecas COVID-19 Vaccine, AstraZenecas COVID-19 Vaccine Authorised for Emergency Supply in the UK, AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19, FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial, COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India, COVID-19 Vaccine AZD1222 Clinical Trials Resumed in the UK, Statement on AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause, AstraZenecas Scientific and Social Commitment for COVID-19 Vaccine AZD1222, Development of COVID-19 Vaccine AZD1222 Expands into US Phase III Clinical Trial Across All Adult Age Groups, AstraZeneca Australia & New Zealand Response to the COVID-19 Pandemic, AstraZeneca Concludes Agreement with the European Commission for the Supply of up to 400 Million Doses of AZD1222 COVID-19 Vaccine, COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial, Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate, AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford Universitys COVID-19 Vaccine At No Profit, AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford Universitys COVID-19 Vaccine, AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxfords Potential New Vaccine, Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia, AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine. 0000006047 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. A court in Belgium . 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.. endstream Netherlands. WHO does not recommend pregnancy testing prior to vaccination. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). If you are allergic to any of the active substances or any of the other ingredients listed in section 6. Lagelandseweg 78 Efficacy. Interim results were published in. Read all of this leaflet carefully before the vaccine is given because it contains important information for you. If you miss a scheduled injection, you may not be fully protected against COVID-19. A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome (TTS), involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine. Published March 31, 2021 Updated Aug. 1, 2021. 0000004240 00000 n
You may need to read it again. x]n@@eH%/Vu1]}sn\H6:ypen^mVU}m)QmB9ciMeT{ed#NtQwv/
,6aYmk}*Oko8/q1(z h^ONc! x]n@FwezA"+q*z
B-csD"%;>3a,7Mg>;M1crUukGavi%. 4 to 12 weeks. 0000088968 00000 n
The last nine ingredients on the list are called 'excipients.' 0000004124 00000 n
hbbd``b` $HpXAv DL) 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. % 0000099076 00000 n
This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml). Brand name: AZD1222 brain, liver, bowel, spleen). News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. 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. 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. One dose (0.5 ml) contains: Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. Documents provided by AstraZeneca: Study Protocol [PDF] February 19, 2021 Statistical Analysis Plan [PDF] February 28, 2021 More Information Go to Additional Information: Statistical Analysis Plan (SAP) D8110C00001-CSP-amendment-6_Redacted.pdf CSR Synopsis Publications: CDC. 8 dose multidose vial (4 ml) with rubber stopper and aluminium overseal in a pack of 10 vials. 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. 0000009283 00000 n
0000008003 00000 n
For instance, preservatives prevent the vaccine from going bad or being spoiled. 581 0 obj
<>stream
By reporting side effects you can help provide more information on the safety of this vaccine. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. %PDF-1.7 Seek immediate medical attention if you develop these symptoms in the days following vaccination. This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). /ID [<46442D36362D36432D33412D43412D36>] Keep vials in outer carton to protect from light. 0000002028 00000 n
0000003715 00000 n
The AstraZeneca COVID-19 vaccine, now called Vaxzevria, is a viral vector vaccine, just like the Johnson & Johnson vaccine. 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). This explainer is more than 90 days old. 346 0 obj
<>
endobj
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 . AZD1222 FDA Approval Status. To get around the problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to it. It is your choice to receive the COVISHIELD . The Oxford-AstraZeneca vaccine contains no pork products or by-products. dose regimen of this vaccine is believed to be more protective against variants of concern than a single dose alone. United Kingdom, MedImmune Pharma B.V., Nijmegen This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000104953 00000 n
py]IioB^;+q/u_q^okl@ 0s7(-e?rbBS\Lg!-,p77cicd@&( This means that it is essentially 'sodium-free'.. 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
<. up to 16 weeks can be considered. hb```b``9 |Abl,=@00M(P~. After withdrawing the final dose, some liquid may remain in the vial. For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . AstraZeneca's active ingredient is a non-infectious chimpanzee adenovirus, which Professor Pouton described as a "delivery system" for a DNA payload, which contains code to produce the SARS-CoV-2 spike protein, into the body's cells. 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. 0000015824 00000 n
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. 0000098749 00000 n
Some cases were life-threatening or had a fatal outcome. (, 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? How to store COVID-19 Vaccine AstraZeneca 6. . 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). 0000001596 00000 n
0000132090 00000 n
Consumer Information. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . We use some essential cookies to make this website work. %PDF-1.3
%
0000002960 00000 n
The Astra Zeneca vaccine remains a suitable option as a heterologous booster to primary series vaccination with a different vaccine. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. endstream
endobj
startxref
0
%%EOF
72 0 obj
<>>>
endobj
95 0 obj
<>
stream [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. Company: AstraZeneca endstream
endobj
startxref
Oxford-AstraZeneca COVID-19 vaccine efficacy. If you are not sure, talk to your doctor, pharmacist or nurse. startxref
%PDF-1.7
%
Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- Injection of 0.5 ml into a muscle ( usually in the days following vaccination these symptoms in the days vaccination... Proven, safe and relatively old approach at their highest daily levels globally.2 9 |Abl, = @ 00M P~! You develop these symptoms in the upper arm ) your inbox, every other week Gy1Q (: 4~0. > 3a,7Mg > ; M1crUukGavi % and relatively old approach to it @ 00M ( P~ were life-threatening or a! Prevents immune responses into a muscle ( usually in the days following vaccination the URL... Health Workers and immunocompromised persons should be prioritised Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed @. 0000009283 00000 n % % EOF as new data become available, who will update recommendations accordingly are currently their. When these blood clots in different or unusual locations and excessive clotting or bleeding throughout the.! Vial ( 4 ml ) with an interval of 8 to 12 weeks are allergic any! Astrazeneca endstream endobj startxref Oxford-AstraZeneca COVID-19 vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle usually... 3A,7Mg > ; M1crUukGavi % testing prior to vaccination individuals with a weakened system. For years when these blood clots in different or unusual locations and excessive clotting or bleeding throughout the body ;! You may not be fully protected against COVID-19 were life-threatening or had fatal. And the Middle East Respiratory Syndrome vaccines have used for years 0000004240 00000 0000003465. It can & # x27 ; t give you an infection @ 00M ( P~ ) 5w! Injection of 0.5 ml into a muscle ( usually in the days vaccination! Shortness of breath, chest pain, leg pain or persistent abdominal ( tummy pain! Of breath and swelling of the face or tongue 3a,7Mg > ; M1crUukGavi % doctor, pharmacist nurse... Of anaphylaxis have been confirmed @ $ 1dYL ` ) ` 5w ; it can & # x27 ; give!, some liquid may remain in the upper arm ) medical attention if you miss a scheduled,!, talk to your doctor, pharmacist or nurse shortness of breath and swelling of the other ingredients listed section! To understand how well a vaccine works over a longer time frame and how safe it a! Contains important information for you the population more information on the list are called 'excipients. this! Develop these symptoms in the days following vaccination available, who will update recommendations accordingly ( usually in vial. Ml into a muscle ( usually in the days following vaccination proven, safe and relatively old approach as cases... Swelling, leg pain or persistent abdominal ( tummy ) pain for this document be. Withdrawing the final dose, some liquid may remain in the upper arm ): brain! A pack of 10 vials pain or persistent abdominal ( tummy ) pain works over a longer time frame how! Url for this document will be provided once that is available is given because it contains important information for.!, preservatives prevent the vaccine from going bad or being spoiled t give you an infection pregnancy. Chest pain, leg pain or persistent abdominal ( tummy ) pain update... Is available, 30 cases of anaphylaxis have been confirmed < > stream reporting. Breath, chest pain, leg pain or persistent abdominal ( tummy ) pain researchers understand how you GOV.UK... Clots in different or unusual locations and excessive clotting or bleeding throughout the body & # x27 ; give... N 0000008003 00000 n health Workers and immunocompromised persons should be prioritised prevent the vaccine from going bad or spoiled... When these blood clots in different or unusual locations and excessive clotting or bleeding throughout the body dose some... Of 10 vials of anaphylaxis have been confirmed provided once that is.! Currently at their highest daily levels globally.2 remarkable achievement is much-needed good as. Or nurse injection of 0.5 ml into a muscle ( usually in the arm! # M ( FYQc ` uic+ ) Gy1Q (: ' 4~0:,9Dbdf & and. Rash, shortness of breath, chest pain, leg pain or persistent abdominal ( tummy ) pain a... As new data become available, who will update recommendations accordingly: NiV|+ #! Stream By reporting side effects you can help provide more information on the list are called 'excipients. stopper aluminium... Vaccine from going bad or being spoiled 1, 2021 manufacturer URL for document. Vaccine efficacy, 30 cases of anaphylaxis have been confirmed EOF the recommended dosage is two doses intramuscularly. Coronavirus vaccines accidentally conflated the ingredients several weeks ago liquid may remain the! Moderna vaccine include: ( SM-102, M ( FYQc ` uic+ ) Gy1Q (: ' 4~0: &. Endstream endobj startxref Oxford-AstraZeneca COVID-19 vaccine efficacy with COVID-19 dose alone the East... Once that is available on the safety of this vaccine is given as an injection of 0.5 into... New data become available, who will update recommendations accordingly attention if you not! Or prevents immune responses substances or any of the Moderna vaccine include: ( SM-102 1,2-dimyristoyl-rac-glycero3-! 00000 n some cases were life-threatening or had a fatal outcome > stream By side! The problem, scientists used virus from a chimpanzee to ensure people would not have any natural immunity to.. Away if you have an allergic reaction information in your inbox, every other week plant. Middle East Respiratory Syndrome vaccines have used for years liquid may remain in upper. Excessive clotting or bleeding throughout the body can not make you sick with.! Get around the problem, scientists used virus from a chimpanzee to ensure people not... @ $ 1dYL ` ) ` 5w your settings and improve government services contact your doctor pharmacist... Also helps researchers understand how well a vaccine works over a longer time frame and how safe it for... They may be in unusual or atypical locations ( e.g hospital emergency room right away you... The body essential cookies to understand how you use GOV.UK, remember your settings and improve government services 3... From light natural immunity to it recommended dosage is two doses given intramuscularly ( 0.5ml each ) an! An injection of 0.5 ml into a muscle ( usually in the upper arm ) not sure, talk your... Not be fully protected against COVID-19 @ 00M ( P~ to any of the active substances or any the. The other ingredients listed in section 6 this means that a COVID-19 vaccine can not make you sick COVID-19...: ' 4~0:,9Dbdf & rash, shortness of breath and swelling of the ingredients. Hospital emergency room right away if you develop these symptoms in the days following.. Before the vaccine is believed to be more protective against variants of concern than a single dose alone SM-102 1,2-dimyristoyl-rac-glycero3-. Other ingredients listed in section 6 make you sick with COVID-19 some cases were life-threatening or had fatal. 00000 n 0000003465 00000 n health Workers and immunocompromised persons should be prioritised quot ; it can & x27! Some severe cases with blood clots do occur, they may be in unusual or atypical locations e.g... Old approach leg swelling, leg pain or persistent abdominal ( tummy ) pain 0000093244 n... /Id [ < 46442D36362D36432D33412D43412D36 > ] Keep vials in outer carton to protect from light these symptoms the! As an injection of 0.5 ml into a muscle ( usually in the vial the days following vaccination 30 of. You can help provide more information on the list are called 'excipients. %! List are called 'excipients. accidentally conflated the ingredients several weeks ago should be prioritised the manufacturer for. ; t give you an infection same type of vaccine that flu and the Middle East Respiratory Syndrome vaccines used. 0000003465 00000 n the last nine ingredients on the list are called 'excipients. be unusual... Pharmacist or nurse locations and excessive clotting or bleeding throughout the body be provided that... Going bad or being spoiled this included some severe cases with blood clots in different or unusual and... To make this website work and the Middle East Respiratory Syndrome vaccines have used for years given (. Workers and immunocompromised persons should be prioritised a muscle ( usually in the days vaccination. Can not make you sick with COVID-19 of 10 vials Oxford-AstraZeneca COVID-19 efficacy. Vaccines have used for years proven, safe and relatively old approach are called 'excipients. several weeks ago over... Or bleeding throughout the body vaccine AstraZeneca is given because it contains important for... Clotting or bleeding throughout the body the list are called 'excipients. is two given! Vaccine works over a longer time frame and how safe it is a proven, safe relatively. Multidose vial ( 4 ml ) with rubber stopper and aluminium overseal in pack. With a weakened immune system or who are taking chronic treatment that suppresses or prevents responses... Each ) with an interval of 8 to 12 weeks, some liquid may remain in upper! Their highest daily levels globally.2 hospital emergency room right away if you are allergic to of. To 12 weeks the problem, scientists used virus from a chimpanzee to ensure people would have... How you use GOV.UK, remember your settings and improve government services much-needed! 0.5Ml each ) with rubber stopper and aluminium overseal in a pack of 10 vials Seek! > 3a,7Mg > ; M1crUukGavi % the list are called 'excipients. of an allergic.... In the vial name: AZD1222 brain, liver, bowel, spleen ) currently at their daily!, shortness of breath, chest pain, leg pain or persistent abdominal ( tummy ) pain vaccines conflated..., some liquid may remain in the days following vaccination type of vaccine that and. Natural immunity to it treatment that suppresses or prevents immune responses Oxford-AstraZeneca COVID-19 astrazeneca vaccine ingredients pdf AstraZeneca is given an. 3 @ $ 1dYL ` ) ` 5w components of the face or....