Phase 3 Vaccine Study by the National COVID Prevention Network (CoVPN)

It is true that the search for a vaccines and monoclonal antibodies against COVID-19 has been happening very quickly, but the Covid-19 prevention Network is not cutting any corners or skipping any steps. All the usual measures to ensure the safety of study participants or the general public are being followed. Our primary concern is the safety of study participants, and the general public who will ultimately get a vaccine that is proven to be effective.

A: There is no licensed vaccine or antibody against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), which is the virus that causes coronavirus disease 2019 (COVID-19). Scientists are working to develop a vaccine and an antibody and do the research to determine whether they are safe and effective against SARS-CoV-2. 

No. That type of study design is known as a challenge study. Instead, we are using a design known as “randomized, blinded, placebo-controlled” studies. We will enroll people who are more likely to be exposed to SARS-CoV-2 infection and COVID-19 illness. Some participants will get the vaccine, and some will get a placebo, which is a sterile salinesolution that does not have any vaccine in it. We expect that some people will be exposed to the virus in their everyday lives, and may become sick. We will compare the 2 groups to see if there are fewer people who get sick in the vaccine group than in the placebo group. This ishow we will know if the vaccine works. 

Unlike guinea pigs, people can say yes or no about joining a study. All study volunteers must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing any of their rights or benefits. The COVID-19 Prevention Network (CoVPN) takes great care to make sure people understand the study fully before they decide whether or not to join. All CoVPN studies follow US federal regulations on research, as well as international ethical standards and any country-specific requirements for the countries where our research is conducted. 

In order to find a vaccine or antibody that works in all kinds of people, it is necessary to test them in all kinds of people. This is especially true for groups of people that have been hardest hit by the COVID-19 pandemic. Protecting the well-being of study volunteers is the greatest responsibility in every study, and the CoVPN works to make sure that our studies follow the highest ethical standards. These studies are done in collaboration with local scientists and researchers and community representatives with oversight by ethics and regulatory groups in each country. Many studies are done in sub-Saharan Africa, Europe, North America, and South America at the same time and we follow the same procedures and international standards no matter where the study takes place. 

No. The vaccines and antibodies being tested by the CoVPN are preventive products. They must be tested on volunteers who do not have COVID-19, because our goal is to keep people healthy. There are other research groups that are conducting studies of treatments that might be used for people who already have COVID-19.

It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two. Many studies have proven that there is no link between vaccines and autism. There is also no linkbetween childhood vaccination and autism. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data and was stripped of his license to practice medicine. The value of protection among vaccinatedindividuals and to the public has made vaccines one of the top public health measures in history, second only to having a clean water supply.

Yes, people who join a study get compensated for their time and inconvenience. The amount per visit varies depending on how long the visit is and the procedures that takeplace. The amount also varies from city to city, because the cost of living is different between large metropolitan areas compared to smaller towns and rural areas. The details about compensation will be explained when a person goes through the informed consent process at a local clinic to join a study.

Operation Warp Speed, a program of the US government, is working to purchase enough COVID-19 vaccines to provide universal coverage for the country. This is done in 2 ways: by buying vaccine doses now, and through an “option to purchase program.” All 5 major companies whose products are being tested in US government-funded studies are participating. This will allow the country to have enough doses for the 220 million adults and 110 million children for whom vaccines could potentially be administered. 

We expect that these 5 different vaccines may have different safety profiles and/or differences in the immune responses people have to them. This could be especially true for women of childbearing age, children, and the elderly. If only a few vaccines are effective, the CDC and the US government’s ACTIV program will establish recommendations for priority populations that should receive the vaccines first. This would be temporary until the option to purchase program results in having enough vaccine doses for optimal coverage. We are confident that this approach will provide enough vaccine doses to vaccinate those in vulnerable populations to protect as many people as possible. 

As part of the US government effort, it is our obligation to ensure that everyone in America is provided with a safe and effective vaccine as soon as possible. Since the vaccine will be purchased by the US government, the vaccine will be affordable for the public. We recognize that vulnerable populations in many underserved communities are among those at highest risk for suffering the consequences of COVID-19. We are committed to vigorous minority community outreach and maximizing access in these communities, including the Black/African American, Latine and Native American populations. 

When a person has completed the submission of their survey online, they will see a message with the heading “Success!” which means that they have successfully submitted their information. The system does not send out an email confirmation message. A person’s information will be provided to a study site closest to their location. If the study site thinks a given person may qualify for a particular study, they will reach out to that person as soon as possible about participating. This could be soon, or it may be in several months, as there are several studies taking place over the next 6 months. We will never ask for financial, credit, or bank account information. We will never ask for an ID number over the phone.

No, there is no way to guarantee whether a person will get the vaccine or the placebo. All the studies will be blinded, which means that neither the study participant nor the clinic staff will know who is getting which product. When someone decides to enroll, it will be a computer who makes a random assignment to the study product group or the placebo group, and only the pharmacist will know which product a person gets. These steps are necessary to ensure that no assumptions are made, and any immune responses or side effects are dealt with equitably, without favoritism. 

The trials are enrolling people with a variety of health conditions, as having underlying health conditions is one of the factors that puts people at risk for more severe COVID-19 illness. We cannot comment on the specifics of any particular study, because each one is different. If someone completes the survey to join our Volunteer Screening Registry, a local study team would be able to follow up if they feel that person is a good match to a study they have available. Once they reach out to a volunteer, a more specific conversation will take place to address concerns and health conditions.

• When a volunteer contacts one of the participating research sites, including Howard University, a study team member will tell them about the COVID-19 vaccine trial.
• A volunteer may be asked personal questions before coming into our research site to help determine if the study open at our site is a good fit for the volunteer.
• A volunteer and/or their legally authorized representative will receive written information about the study, and they will have a detailed discussion with the study staff to assist in making an informed decision about whether they want to join the study or not.
• Most studies require coming into the research site for 10 or more visits over 1-2 years.
• If someone decides to volunteer, the study staff will determine if they are eligible to join. This can include things like asking about medical history and doing a physical exam. Sometimes a blood sample will be drawn for necessary lab tests.

• Most studies require coming into the research site for 10 or more visits over 1-2 years. 
• Every study involves getting injections or infusions. A study volunteer might get the study product being researched, or they might get a placebo (a liquid with no active ingredients). 
• When someone enrolls in the study, the study team will the volunteer to keep track of how they feel for about a week following each infusion or shot. The study staff will also be in contact with the volunteer to find out how they are feeling during this time. 
• Volunteers will not be exposed to the SARS-CoV-2 virus as part of the study. 
• If a study volunteer becomes infected with SARS-CoV-2 and becomes ill with COVID- 19, the study staff will work with them to make sure they get the care needed. 

• The study volunteer may be asked if they can be contacted again for another study. 
• When the study is complete, the results will be disseminated to all participants and their communities without any identifying information.