Informed Consent Letter for Inactivated Vaccinations against COVID-19 Virus
[Introduction to the disease]COVID-19 Virus pneumoniais a new infectious disease that is caused by a new corona-virus infection, transmitted through respiratory droplets and contact, therefore the public is easily infected by it. Common clinical manifestations include fever, fatigue, dry cough, etc. A small number of patients are accompanied by nasal congestion, runny nose, sore throat, myalgia, and diarrhea. Theoverall prognosis is good, but a small number of patients may develop critical illnesses such as multiple organ damage.
[Introduction to the vaccine]The inactivated vaccine against COVID-19 Virus used in this vaccination will be one of three inactivated vaccines developed by the following institutions, namely SINOVAC Research & Development Co., Ltdtogetherwith SINOVAC BIOTECH CO.,LTD., the SINOPHARM Beijing together with Chinese Center for Disease Control and Prevention, andSINOPHARM Wuhan in conjunction with the Wuhan Institute of Virology,Chinese Academy of Sciences. At present, inactivated vaccines against COVID-19 Virus produced by the theseinstitutions are undergoing phase III clinical trials and have not yet been launched, but according to the current needs for the prevention and control of COVID-19, and in accordance with the relevant provisions of the “People's Republic of China Vaccine Management Law”, this vaccine can be used for emergency.
[Age limit of the vaccination]The current age limit is 18 to 59 years old.
[Inoculation dose, location, route]0.5ml per dose, IM injection injected into the lateral deltoid muscle of the upper arm.
[Immunization procedure]2 doses in total, with an interval of 21-28 days between each dose; see the vaccine instructions for details.
[Suspected vaccination abnormal reactions]1. Common suspected vaccination abnormal reactions involve: pain, tenderness, redness, swelling, itching, transient fever, etc. at the injection site. Generally, it does not need special treatment, ifnecessarysymptomatic treatment can be done.
2. Infrequently suspected abnormal response to vaccination: normal flu symptoms and general malaise, induration of the vaccination site, severe fever, etc.
3. Extremely rare suspected abnormal reactions of vaccination: aseptic suppuration allergic rash, allergic purpura, anaphylactic shock, etc.
[People not suitable for vaccination]Due to the limited data of clinical trials conducted, the following people are not included in this vaccination
1. Pregnant women.
2. Those who have had severe allergic reactions, such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain, orhave known allergies to THISCOVID-19 vaccine.
3. History or family history of convulsions, epilepsy, encephalopathy, mental illness.
4. Fever, acute illness and acute episode of chronic illness.
5. Severe chronic diseases.
[Precautions]
1. Use with caution for people with allergies.
2. Suspend vaccination for those who have a family plan within 3 months of vaccination.
3. People who inject immunoglobulin should receive this vaccine at least one month apart.
4 If any neurological reaction occurs after injection, it is forbidden to use it again.
5. Because of the characteristics of the vaccine or individual differences of the recipients, the protective effect of this vaccine cannot reach 100%, after vaccination personal protection is still required.
6. After vaccination, stay in the observation area for 30 minutes. If you feel unwell after vaccination, please inform the vaccination doctor in time.
7. This is a voluntary vaccination. If any abnormal response to vaccination occurs after vaccination, compensation will be made in accordance with relevant state regulations.
Please sign to confirm!
(The English translation is for reference only. In case of discrepancy, final interpretation will take Chinese version as standard.)
Recipient’s Signature: Date: YY, MM, DD
