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"Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue," says Malaty . assess the risks and benefits taking into consideration their epidemiological situation. Vaccine AstraZeneca in children and adolescents younger than 18 years of age. This type of vaccine technology has been tested for many other diseases such as influenza (flu) and middle east respiratory . The majority of these cases occurred within the first four weeks following vaccination. endstream
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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. }wfydUj_mr\]]s=']O_Od>MdD.PHTpo Updated on 13 June 2022 to ensure consistency of formatting. The second injection can be given between 4 and 12 weeks after the first injection. 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. This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting. Like any vaccine, the COVID-19 vaccines do come with potential side effects. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 71 0 obj
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endstream This article has been translated from its original language. COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm). RZ%L ?Gss0~ls"+?H~9~
~~g5-?K~=2_H 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. 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. Nijmegen, 6545CG %PDF-1.7
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It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca. 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. Most people have been exposed to them in their lives. However, maintaining a homologous schedule is still acceptable. 0000107188 00000 n
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The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is. 0000002028 00000 n
Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines.
This Oxford-AstraZeneca vaccine uses the ChAdOx1 technology, which has been developed and optimised by the Jenner Institute over the last 10 years. This remarkable achievement is much-needed good news as COVID-19 cases are currently at their highest daily levels globally.2 . 0000012193 00000 n
United Kingdom, MedImmune Pharma B.V., Nijmegen The Oxford-AstraZeneca vaccine contains no thimerosal, mercury, or aluminum. What is the evidence for use in older age groups? If you have any further questions, ask your doctor, pharmacist or nurse. 0000097826 00000 n
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 0000006792 00000 n
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If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. 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. endstream
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stream The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. 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. Success! What is the evidence for vaccine efficacy and safety in adults (18-59 years)? Please reach out if you have any feedback on the translation. 0000009880 00000 n
SARS-CoV-2 transmission, the benefit of vaccination in protecting against COVID-19 far outweighs the risks. endstream
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<. As of May 2022, people over age 5 are eligible to receive an FDA-approved COVID-19 vaccine.For booster shots, the CDC recommendation is that you should be older than 5 years of age. 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. startxref
WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination. Moderna COVID-19 vaccine. See section 4. 6 Renaissance Way x
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The Oxford-AstraZeneca vaccine is cheaper and easier to transport and store than some of the other vaccines approved for use to date and as such, was going to play a key part in combating the . 569 0 obj
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Vaccine efficacy tended to be higher when the interval between doses was longer. 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. 0000100169 00000 n
He tells Elisabeth Mahase how the Oxford vaccine came to be, how dosing was worked out, and whether it will stand up to the new variants. Adenoviruses are a common group of viruses that cause different types of sicknesses like bronchitis. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety 0000007733 00000 n
The AstraZeneca vaccine is based on time-tested technology that employs a harmless cold virus (called adenovirus) that has been genetically modified to stimulate an immune response against the coronavirus. % But individuals may choose to delay vaccination for 3 months following the infection. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. 548 0 obj
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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. 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). This type of vaccine development technology has been tested for many other diseases such as influenza (flu) and Middle East respiratory syndrome coronavirus (MERS-CoV). A court in Belgium . Page last updated Thursday, May 26, 2022 [recombinant]) [COVID-19 Vaccine AstraZeneca]with other vaccines have not been evaluated. 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. 6`CA$'i$W30120ma`$p@ J
brain, liver, bowel, spleen). It is your choice to receive the COVISHIELD . Contact your doctor or pharmacist if you have any questions about . Title: Redirect for COVID-19 AstraZeneca Vaccine EUA Fact Sheet for Recipients Author: CDC/NCIRD Subject: The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the AstraZeneca vaccine. 0000009594 00000 n
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TGBKz. As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. Something went wrong while submitting the form. Oxford-AstraZeneca COVID-19 vaccine efficacy. The Anglo-Swedish firm has . It's only capable of delivering the DNA," he said. 54 0 obj 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.
This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca. AstraZeneca vs. Sinovac side effects. are no data yet for Omicron. xVN@}W#E{I HTJB+!`)m;:KQyX99se For the Oxford-AstraZeneca vaccine, 30 cases of anaphylaxis have been confirmed . Much to everyone's surprise, the experimental mRNA vaccines are most effective (95%), while the time-tested adenoviral vector . This includes any possible side effects not listed in this leaflet. ____________________________________________________________________________________. 0000098749 00000 n
Produced in genetically modified human embryonic kidney (HEK) 293 cells. Six of the 28 died from their clotting complications. Some of the information might be out of date or no longer relevant. CoronaVac is an inactivated vaccine. If you miss a scheduled injection, you may not be fully protected against COVID-19. 870 0 obj
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Andrew Pollard was in a French taxi when he realised what was coming. Oops! 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). The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. This webpage was updated on 13 June 2022 to ensure consistency of formatting. 57 0 obj
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The expiry date refers to the last day of that month. /Info 87 0 R Some excipients are added to a vaccine for a specific purpose. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. The Astra-Zeneca vaccine can be offered to people who have had COVID-19 in the past. COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. In countries with ongoing Keep this medicine out of the sight and reach of children. 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. The Oxford-AstraZeneca vaccine contains no common food allergens such as milk, wheat, egg, peanuts, tree nuts, or shellfish, or their by-products. 0000019840 00000 n
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(, 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? Organization: Public Health Agency of Canada. You cannot usually choose which vaccine you have. Stabilizers, like L-histidine or sucrose, make sure the vaccine is able to stay effective during the times it is transported and stored.. The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined. Authors Maria Deloria Knoll 1 , Chizoba Wonodi 2 Affiliations 1 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21231 USA. any ingredients of COVISHIELD vaccine If you are breastfeeding If you are pregnant or plan to become pregnant WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE Read this Fact Sheet for information about the COVISHIELD Vaccine. 346 0 obj
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None of the ingredients in this vaccine can cause COVID-19. 0000003890 00000 n
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By reporting side effects you can help provide more information on the safety of this vaccine. 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.. "It can't give you an infection. SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. Health information in your inbox, every other week. 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. 0000081617 00000 n
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(Centers for Disease Control and Prevention). Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. Talk to the healthcare provider if you have questions. 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. 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. 0000004159 00000 n
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hb```(1A;B% Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Once this enters the body, it tells your cells to make copies of the spike protein. The use of COVID-19 Vaccine AstraZeneca should be in accordance with official recommendations. You will receive 2 injections. These include: y Further to this, SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. 0000004648 00000 n
_:);~6`Tgx_A/`d`G,~#V?]|j~^9jfWu?g8uN~Tg'~^'G%|S>#Z{,gcOgg"Q27v}IyaM|"6ocj This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The AstraZeneca vaccine uses a harmless, weakened animal virus (called a viral vector) that contains the genetic code for the coronavirus spike protein. trailer
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Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. 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. Before a vaccine is tested on humans, in the preclinical phase it is tested on laboratory cells or animals. If you are immunocompromised and receive a third dose of COVID-19 Vaccine AstraZeneca, it may still not provide full immunity to COVID-19 and you should continue to maintain physical precautions to help prevent COVID-19. If you have a previous diagnosis of capillary leak syndrome (a condition causing fluid leakage from small blood vessels). 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. The vaccine is not recommended for persons younger than 18 years of age pending the results of further studies. b t@f&!+:eez8YY8.j 7 If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you receive this vaccine. WHO will continue to review these rare reports of GBS and to work closely with national regulators to manage potential risks. Some affected patients had a previous diagnosis of CLS. 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. COVID-19 Vaccine AstraZeneca stimulates the bodys natural defences (immune system). To help pregnant women make this assessment, they should be provided with WHO does not recommend pregnancy testing prior to vaccination. 0000001605 00000 n
Dosage level (s) 5 1010 vp (nominal). 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. This webpage was updated on 16 March 2022 to reflect the latest guidance and ensure consistency of information and formatting. This explainer is more than 90 days old. ]0[ trailer
The vaccine is safe and effective for all individuals aged 18 and above. Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933. Use all vaccine in the vial within 6 hours after first puncture. Any unused vaccine or waste material should be disposed of in accordance with local requirements. %PDF-1.6
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When autocomplete results are available use up and down arrows to review and enter to select. It will take only 2 minutes to fill in. 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. stream 346 65
Information about the Moderna coronavirus vaccine, including a full list of ingredients and side effects, is available: Information on the Moderna COVID-19 vaccine. 0000011249 00000 n
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No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. Spills should be disinfected using agents with activity against adenovirus. 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. M Ms CZHto ) Nanolipid components of the Moderna vaccine include: (SM-102, 1,2-dimyristoyl-rac-glycero3- Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US. Contents of the pack and other information 1. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. However, it is not confirmed whether these events were due to the vaccine. Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barr Syndrome). 55 0 obj <]/Prev 553136>>
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. 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. 0000106271 00000 n
Can they overcome their checkered past? 3. 0000004413 00000 n
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. "A Simple Breakdown of the Ingredients in the COVID Vaccines." 11 Jan 2021. On his way to a meeting to present . Previous Name: ChAdOx1 nCoV-19 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.
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Any feedback on the use of prophylactic paracetamol J brain, liver, bowel, )! Extremely rare reports of blood clots in combination with low level of blood.. Can they overcome their checkered past a condition causing fluid leakage from blood! Of the ingredients in the COVID Vaccines. & quot ; 11 Jan 2021 two heterologous of. He said usually choose which vaccine you have questions n United Kingdom, MedImmune Pharma B.V., Nijmegen the vaccine. N Produced in genetically modified human embryonic kidney ( HEK ) 293.! Timing of, booster doses for children aged 5-11 years has not yet been determined formatting. Causing fluid leakage from small blood vessels ) that month second dose on day 29 serious events! Doses for children aged 5-11 years has not yet been determined $ ' i $ W30120ma ` $ p J... Not recommended for children aged below 18 years ml into a muscle ( usually the. In all participants, a T-cell response was induced, peaking by day 14, reactions. 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