Filipino Healthcare Professionals are among the participants for the Phase 3 Clinical Trials, these frontliners volunteered themselves for the success of the vaccine against COVID-19 for welfare of mankind. These tests covered 6,000 volunteers composed of different nationalities that commenced on 16th of July 2020 in United Arab Emirates.
The volunteers are informed that test will be a Phase III Clinical Trial Of COVID-19 Inactivated Vaccine. The dosage is clearly stated in the procedures for those who will get the 1st dose of of COVID-19 Inactivated Vaccine (Vero Cell). Most participants are healthy individuals and 18 years old and above.
Below are the clear-cut guidelines being followed during the Phase 3 Clinical Trials:
- Informed Consent.
- Medical History, Physical Examination and Consultation (including Swab Test).
- Sample Collection: 12.5ml of venous blood for antibodies testing.
- Immunization (Vaccine or Placebo— 2:1 ratio)— IM route, lateral deltoid muscle of the upper arm. Schedule: Day 0, 21/28. A booster dose might be vaccinated later if needed.
- 30-minute Observation.
- Sample collection after vaccination.
- Follow-up phone calls and visits will be conducted for about 12 Months from first vaccination (Duration of involvement in the study is about 1 Year).
- In case of COVID-19 Infection, a blood sample will be withdrawn to perform laboratory assessment for your health.
Related Risks:
- Pain, redness, induration and pruritus at vaccination site.
- Systemic reactions such as fever, headache, fatigue, nausea, vomiting, allergy, muscle pain, arthralgia, lethargy, convulsion etc. Generally, there is no need for treatment, it subsides on its own. Patients with severe symptoms can be given symptomatic treatment under the guidance of doctors. Occasionally severe allergic reactions occur, and timely treatment should be required.
This Phase 3 Clinical Trial passed already the Phase 1 and 2 with 100 percent of the volunteers generated antibodies for SARS-CoV-2 that causes Covid-19. This program is 4Humanity Campaign in support for the fast phase search for the development of vaccine against this COVID-19 pandemic.
With a month after the Phase 3 Clinical Trial on COVID-19 facilitated in the middle east, another breakthrough was announced by Russia that “SPUTNIK V” passed and accepted for production that hopefully 1st batch will be released soon somewhere on September or October of this year 2020. Hopefully, this “SPUTNIK V” will be the new effective and efficient vaccine for COVID-19 that will protect the health of mankind for long duration of time!
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