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Additional frequently asked questions about the study.
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Additional frequently asked questions about the study.
The Moderna COVID-19 vaccine used in this study is under an Emergency Use Authorization in the United States. This vaccine is also on the Emergency Use Listing by the World Health Organization which recommends its use to prevent COVID-19 disease. It has been given to more than 70 million people and has been shown to be over 90% effective in preventing COVID-19 illness caused by the strains of the virus in the US and Europe. And to date there have been no significant safety concerns associated with this vaccine.
Over 70 million people have already received the Moderna COVID-19 mRNA vaccine being used in this study. Most people have mild to moderate reactions after receiving the vaccine, particularly after a second dose. These reactions usually happen one or two days after receiving the vaccine. For most people these reactions do not affect their daily lives and go away within a few days. Common reactions include pain in the arm where the injection was administered, fatigue, headaches, muscle and joint pain, and chills. Occasionally people have redness or swelling where the injection was administered. An extremely small number of people who receive the Moderna COVID-19 mRNA vaccine develop myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart). The chance of developing this reaction is very, very low. When it happens, it most often occurs in men less than 20 years of age. Symptoms usually do not last long and most people get better. Study participants should tell us right away if they develop chest pain; shortness of breath; or the feeling of a fast-beating, fluttering, or pounding heart after receiving a dose as they may need medical care.
While the Moderna COVID-19 mRNA vaccine being used in the UBUNTU study may not prevent all SARS-CoV-2 virus infections, studies done in the United States and Europe have found that the vaccine is very effective at preventing severe COVID-19 illness and death. And it has been shown to work well against most strains of SARS-CoV-2 there. However, there is less known about how well the vaccine will protect people in Eastern and Southern Africa.
The UBUNTU study is not the same as the National COVID-19 vaccine rollout, it is a research study to evaluate the Moderna COVID-19 mRNA vaccine. Research is not the same as medical care. The purpose of a research study is to answer a scientific question. If you have access to other COVID-19 vaccines outside of this study through a national rollout, we urge you to carefully consider whether joining this study is right for you. Take your time in deciding. If it helps, talk to people you trust, such as your doctor, friends, or family.
Protecting the health and respecting the rights of participants are top priorities for everyone in the CoVPN. Without volunteers, we would never have been able to develop any of the COVID-19 vaccines. A first step in protecting the rights of study participants is to give them information about the study before they join. Clinic staff will give people information about the study product and procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they want to stay in it, and the right to leave the study at any time. During the study, the clinic staff will monitor participants to make sure the study vaccine is not causing any health problems. There are several groups involved in protecting participants’ rights and well-being:
-A study Protocol Safety Review Team (PSRT) and an independent Data Safety Monitoring Board (DSMB) regularly look at the health information from the study to decide whether it appears safe to continue giving study injections as planned.
-An Institutional Review Board (IRB) or Ethics Committee (EC) reviews and monitors the study plan for each clinic doing the study, including the information that is given to people about the study, study progress, and health problems in participants. The IRB/EC also looks at whether participant rights are being respected.
-The South Africa Health Products Regulatory Authority (SAHPRA), as well as national regulatory authorities of other countries, oversee the conduct of the study and require regular reports on the safety of participants.
-Because funding for the study is provided by the US National Institutes of Health, the study will follow all the international and US laws that govern research in humans and the use of vaccines in research.
-Some clinics have a special EC that oversees the place where blood and other samples are stored. These places are called bio-banks or repositories.
-Each study clinic has a Community Advisory Board (CAB). Its members are local people who bring the concerns and interests of the community and study participants to the researchers. CAB members are part of the team that developed this study. They also help develop or review the information that is given to participants.