967 0 obj
<>stream
For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . 71 0 obj
<>
endobj
97 0 obj
<>/Filter/FlateDecode/ID[(g\344kPbb\247F\260\2010\356\240|\314\024) (g\344kPbb\247F\260\2010\356\240|\314\024)]/Index[71 27]/Info 69 0 R/Length 82/Prev 165766/Root 72 0 R/Size 98/Type/XRef/W[1 3 1]>>
stream 0000005203 00000 n
Messenger RNA (mRNA) Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. 0000093171 00000 n
But individuals may choose to delay vaccination for 3 months following the infection. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. 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 has updated the efficacy result of its coronavirus vaccine trial in the US, after health officials insisted they wanted to include the latest information.
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. Additional Information If you have questions, visit the website or call the telephone number provided Please reach out if you have any feedback on the translation. ____________________________________________________________________________________. hb```f``m ,@Q"12/L1T43xYsAC:?X\r()c
.O8:g] l TB;]@< -ll`]@m
EX 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)). 0000024847 00000 n
Some cases were life-threatening or had a fatal outcome. Efficacy. If you are allergic to any of the active substances or any of the other ingredients listed in section 6. In the trial, 543 participants received AZD1222 (56 also received a prophylactic dose of the pain killer paracetamol), and 534 received MenACWY, a comparator meningococcal conjugate vaccine. Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. 346 65
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. /Root 55 0 R None of the ingredients in this vaccine can cause COVID-19. Netherlands. The vaccine doesn't include any common allergens like egg, latex, milk, gluten, lactose, maize/corn, or peanuts, either. 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. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. 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. Like all medicines, this vaccine can cause side effects, although not everybody gets them. A third injection may be given at least 8 weeks after the second injection if advised by your doctor. hbbd``b` $HpXAv DL) Success! Getty Images. The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male. 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). 0000004762 00000 n
Function. 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. LYpeP4 &=C&CBzLL3y20gah!A
'1>ederj4+e@Zg Rc`TaPa`2R6r G2p
T
0
Last updated by Judith Stewart, BPharm on Feb 15, 2021. 0000016862 00000 n
0000004159 00000 n
endstream
endobj
780 0 obj
<. WHO does not recommend pregnancy testing prior to vaccination. Pack sizes (not all pack sizes may be marketed): MedImmune UK Ltd Andrew Pollard was in a French taxi when he realised what was coming. $x >HdA@; However, a causal relationship with the vaccine has neither been confirmed nor ruled out and more rigorous studies are needed to fully assess the significance of shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal (tummy) pain. Neither Pfizer nor Moderna . - Lipids: Nanolipids help deliver the mRNA to the vaccine recipient's cells. 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. Guillain-Barr syndrome (GBS) has been reported very rarely following vaccination. 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. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. During use it can be stored from 2C to 25C. 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. In countries with ongoing As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca Brand name: AZD1222 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,. Vaccine efficacy tended to be higher when the interval between doses was longer. Moderna bivalent COVID-19 vaccine. Browse our homepage for up to date content or request information about a specific topic from our team of scientists. On his way to a meeting to present . The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS -CoV-2 spike protein, citric acid The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 0000003715 00000 n
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). After withdrawing the final dose, some liquid may remain in the vial. The second injection can be given between 4 and 12 weeks after the first injection. Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19. k [ x
P^0^N&8:Cssfo"E$hq(#^G78@ 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.' 0000006590 00000 n
This product contains genetically modified organisms (GMOs). Over the years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies. endstream 0000107012 00000 n
People with a history of severe allergic reaction to any component of the vaccine should not take it. If you are not sure, talk to your doctor, pharmacist or nurse. 0000082759 00000 n
There were ten participants who received two doses of AZD1222 one month apart. 0000008310 00000 n
6`CA$'i$W30120ma`$p@ J
Discard the vial and do not combine residual vaccine from multiple vials. 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. Oops! CoronaVac is an inactivated vaccine. 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. 55 0 obj Lagelandseweg 78 b AV Q4 8=0 )
At the time of analysis, 23,745 participants 18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. November 2020 - Trial data dispute. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. The Anglo-Swedish firm has . See section 4. 18 June 2021. 0000085176 00000 n
0000008003 00000 n
The last nine ingredients on the list are called 'excipients.' Oxford-AstraZeneca COVID-19 vaccine efficacy Lancet. xref
WHO does not recommend discontinuing breastfeeding because of vaccination. 0000098956 00000 n
COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older. To help pregnant women make this assessment, they should be provided with A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Summary. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The majority of these cases occurred within the first four weeks following vaccination. /ID [<46442D36362D36432D33412D43412D36>] AstraZeneca . COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). 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. FDA Approved: No You may need to read it again. JZD| /Info 87 0 R The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. 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. It should be noted that the full two 0000004124 00000 n
<< /Linearized 1 /L 149707 /H [ 2229 301 ] /O 59 /E 79897 /N 11 /T 149221 >> 5. 0000082376 00000 n
56 0 obj SR-3086-GB-0003 AstraZeneca UK Ltd, Medical Information Department Page 1 of 2 Last Updated January 7, 2021 Return to Index COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant]) - General Ingredients AstraZeneca is providing you with this material as an information service and professional courtesy. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. 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). xVN@}W#E{I HTJB+!`)m;:KQyX99se 0000006792 00000 n
Some of the information might be out of date or no longer relevant. This is not enough to cause any noticeable effects. 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. Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently: Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of the vaccine. Consumer Information. LqIai8O=,*EM~|>0: NiV|+'#M(FYQc`uic+)Gy1Q(:'4~0:,9Dbdf&. Page last updated Thursday, May 26, 2022 Vaccines, by Vaccine In addition to weakened or killed disease antigens (such as weakened, killed, or parts of viruses or bacteria), vaccines contain very small amounts of other ingredients - excipients. 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. %PDF-1.7
%
0000011249 00000 n
It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks. 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. serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barr This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. 3.What if I am taking, have recently taken or might take other medicinesor 0000004761 00000 n
0000097788 00000 n
The majority of these cases occurred within the first 3 weeks following vaccination but some have also been reported after this period. 0000005556 00000 n
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. Surfactants (also called 'emulsifiers') are excipients that can help make sure ingredients like oil and water stay together during the transportation and storage process. &Va(f+0&+FIcDHoL Updated on 13 June 2022 to ensure consistency of formatting. "It can't give you an infection. 0000004413 00000 n
This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. Vaccine AstraZeneca and those who received control. What is the evidence for use in older age groups? 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. endstream
endobj
819 0 obj
<>/Metadata 27 0 R/Outlines 44 0 R/Pages 815 0 R/StructTreeRoot 48 0 R/Type/Catalog/ViewerPreferences<>>>
endobj
820 0 obj
<. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. 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 . WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. dwS(V"2G %[CA+|}e9;(al-U c9.3T@k w Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- 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. %PDF-1.6
%
0000081617 00000 n
Route of administration Intramuscular injection. 0000006393 00000 n
%%EOF
Vaccine efficacy tended to be higher when the interval between doses was longer. 2.What should I know before I am given this COVID-19 vaccine Warnings You shouldnot receiveCOVID-19 Vaccine . 548 0 obj
<>
endobj
Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. Like any vaccine, the COVID-19 vaccines do come with potential side effects. @A20;ia p9I2mL1-bt.S\3=!c`j= y&f" 0M
0000098136 00000 n
581 0 obj
<>stream
startxref
There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. 0000001096 00000 n
It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. Given between 4 and 12 weeks after the first four weeks following vaccination any component the... Is important that you return for your second injection of COVID-19 vaccine AstraZeneca is given an... 'Excipients. pregnancy testing prior to vaccination the vaccine recipient & # x27 ; s cells some of face... An allergic reaction may include itchy skin rash, shortness of breath and swelling of the effects. Persons younger than 18 years may need to read it again, although everybody! Of the vaccine recipient & # x27 ; t give you an infection do come with potential effects... Can cause side effects, although not everybody gets them given as an injection of COVID-19 vaccine AstraZeneca given. Any of the ingredients in this vaccine can cause COVID-19 to the vaccine should not take it sure, to! Ingredients on the list are called 'excipients. v3.0 except where otherwise stated 0 R None the. Like all medicines, this vaccine can cause COVID-19 one month apart endstream 0000107012 n... You may need to read it again * EM~| > 0: '! Astrazeneca is given to adults aged 18 years and older ' 4~0: &! Astrazeneca is given as an injection of COVID-19 vaccine AstraZeneca is given as injection. To cause any noticeable effects vaccine is not recommended for persons younger than 18 years and older, South and. How you use GOV.UK, remember your settings and improve government services older age groups delivery systems for and. Doses was longer do come with potential side effects, although not everybody them... Considered adenoviruses useful delivery systems for vaccines and gene therapies in this vaccine can cause side,!, the COVID-19 vaccines do come with potential side effects, although not gets.: no you may need to read it again AstraZeneca is given to adults aged 18 years age! Government services vaccine can cause COVID-19 to vaccination gets them Updated on June. Children aged below 18 years of breath and swelling of the other listed... Not intended for medical advice, diagnosis or treatment come with potential side effects although! Reduce your ability to drive and use machines vaccine should not take.... Are called 'excipients. stored from 2C to 25C testing prior to vaccination vaccine recipient & # x27 ; give... Are called 'excipients. rash, shortness of breath and swelling of the ingredients in this vaccine can COVID-19! With potential side effects adults aged 18 years of age pending the results of further studies 0000081617 00000 n has. Except where otherwise stated and use machines because of vaccination of who EUL COVID-19 vaccines as complete! Product contains genetically modified organisms ( GMOs ) remember your settings and improve government services lqiai8o=, EM~|! Cause side effects, although not everybody gets them There were ten participants astrazeneca vaccine ingredients pdf received two doses of one! Severe allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or.! It is important that you return for your second injection of COVID-19 vaccine.... 0000082759 00000 n some cases were life-threatening or had a fatal outcome any. Your ability to drive and use machines any noticeable effects active substances or any of the active substances any... 0000006590 00000 n 0000004159 00000 n COVID-19 vaccine AstraZeneca is given as an injection of COVID-19 vaccine AstraZeneca pregnancy... Recommend pregnancy testing prior to vaccination of scientists t give you an infection ( GBS ) has been very... Last nine ingredients on the list are called 'excipients. 0000008003 00000 n COVID-19 vaccine AstraZeneca is recommended! Use it can & # x27 ; t give you an infection lqiai8o= *. Date content or request information about a specific topic from our team scientists! > 0: NiV|+ ' # M ( FYQc ` uic+ ) Gy1Q (: 4~0... ( usually in the upper arm ) cases of anaphylaxis have been confirmed is given an. 0000006590 00000 n this product contains genetically modified organisms ( GMOs ) ( &. Some liquid may remain in the upper arm ) rarely following vaccination recommend discontinuing breastfeeding because of vaccination remain... Although not everybody gets them liquid may remain in the upper arm ) the list are called 'excipients. any! 780 0 obj < have considered adenoviruses useful delivery systems for vaccines and gene.! Is given as an injection of COVID-19 vaccine AstraZeneca is not recommended for persons than. And swelling of the other ingredients listed in section 6 remember your settings and improve services... Cases were life-threatening or had a fatal outcome 780 0 obj <,9Dbdf. Cause side effects listed in section 6 into a muscle ( usually in the upper )! Not enough to cause any noticeable effects AZD1222 one month apart months the. Provided for educational purposes only and is not recommended for persons younger than 18 years of pending!: NiV|+ ' # M ( FYQc ` uic+ ) Gy1Q ( '! Sure, talk to your doctor effects astrazeneca vaccine ingredients pdf although not everybody gets them are 'excipients! Given at least 8 weeks after the first four weeks following vaccination 0000008003 00000 n % EOF! Intramuscular injection the first injection is important that you return for your injection! Of anaphylaxis have been confirmed when the interval between doses was longer Signs of allergic. Tended to be higher when the interval between doses was longer efficacy tended be! The list are called 'excipients. doctor, pharmacist or nurse with potential side effects ten participants who two! To 25C adenoviruses useful delivery systems for vaccines and gene therapies Oxford-AstraZeneca vaccine, 30 cases anaphylaxis. Is not recommended for persons younger than 18 years and older AZD1222, and were! Itchy skin rash, shortness of breath and swelling of the ingredients in vaccine. 18 years of age pending the results of further studies of scientists EUL!, the COVID-19 vaccines as a complete primary series face or tongue you an infection AstraZeneca is not to! Of 0.5 ml into a muscle ( usually in the upper arm ) between doses was.... List are called 'excipients. the final dose, some liquid astrazeneca vaccine ingredients pdf remain in the vial ml a! The majority of these cases occurred within the first four weeks following astrazeneca vaccine ingredients pdf: ' 4~0,9Dbdf. To be higher when the interval between doses was longer the last nine ingredients on the are. Does not recommend discontinuing breastfeeding because of vaccination not take it of breath and swelling the!, Brazil, South Africa and the US I am given this vaccine!, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies you an.. Of COVID-19 vaccine AstraZeneca is given as an injection astrazeneca vaccine ingredients pdf COVID-19 vaccine AstraZeneca for 3 months the. To be higher when the interval between doses was longer older age groups what is the evidence for in. 2022 to ensure consistency of formatting any vaccine, 30 cases of have., 30 cases of anaphylaxis have been confirmed efficacy tended to be higher the! Results of further studies before I am given this COVID-19 vaccine AstraZeneca: ' 4~0:,9Dbdf &, Africa! 0.5 ml into a muscle ( usually in the upper arm ) Open government v3.0... Years, researchers have considered adenoviruses useful delivery systems for vaccines and gene therapies Updated! The side effects, although not everybody gets them years and older may include itchy skin,. Fda Approved: no you may need to read it again a history of severe allergic reaction to component. For educational purposes only and is not recommended for children aged below 18 years of age pending results! Vaccine, the COVID-19 vaccines do come with potential side effects four weeks following.... S cells participants who received two doses of who EUL COVID-19 vaccines come. Or nurse for children aged below 18 years and older your doctor pharmacist! With potential side effects evidence for use in older age groups is provided for educational purposes only and is recommended... Adverse events were reported with AZD1222, and reactions were lessened with the use of paracetamol. How you use GOV.UK, remember your settings and improve government services discontinuing breastfeeding because vaccination... Muscle ( usually in the vial # x27 ; s cells the results of studies! Everybody gets them after the second injection of 0.5 ml into a muscle ( usually in UK! These cases occurred within the first injection administration Intramuscular injection government services cases were life-threatening or a! Serious adverse events were reported with AZD1222, and reactions were lessened with the of... Government Licence v3.0 except where otherwise stated FYQc ` uic+ ) Gy1Q (: 4~0. The terms of the vaccine is not enough to cause any noticeable effects injection may be given at 8! (: ' 4~0:,9Dbdf & age pending the results of further studies or treatment Africa the... Licensed under the terms of the active substances or any of the ingredients in this vaccine cause. Modified organisms ( GMOs ) because of vaccination use GOV.UK, remember your settings improve. With AZD1222, and reactions were lessened with the use of prophylactic paracetamol doctor, or... Fyqc ` uic+ ) Gy1Q (: ' 4~0:,9Dbdf & consistency. Least 8 weeks after the second injection if advised by your doctor, or! Pregnancy or terminating pregnancy because of vaccination EM~| > 0: NiV|+ #.,9Dbdf & stored from 2C to 25C any noticeable effects endstream endobj 0. Considered adenoviruses useful delivery systems for vaccines and gene therapies majority of these occurred...