Frequently Asked Questions
Does a vaccine or antibody against SARS-CoV2 or COVID-19 already exist?
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 very hard to develop a vaccine and an antibody and do the research to determine whether they are safe and effective against SARS-CoV-2.
Will study participants be given SARS-CoV2 or COVID-19 as part of the study?
No. That type of study design is known as a challenge study. Instead, we are using a design known as “randomized, blinded, placebo-controlled” study. 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 saline solution 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 is how we will know if the vaccine works.
What is it like to part of a vaccine research study?
People can say yes or no about joining a study. All study participants must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study. Additionally, anyone may choose to 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.
Are vaccines safe?
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 link between 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.
Will I be able to tell if I received a placebo?
No, neither the participant, nor the clinical study team will know who receives the vaccine and who receives the placebo. Only a select group of non-clinical study staff will have access to this information. Since we do not know who has gotten the vaccine and who has gotten the placebo, and we do not know if the vaccine will be effective, all participants will be strongly advised to continue all public health social distancing recommendations to minimize their risk of acquiring SARS-CoV-2/COVID-19.
Do study participants get paid?
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 take place. The details about compensation will be explained to you during the informed consent process before you join a study.
What happens after I submit my survey to the Volunteer Screening Registry?
When you have completed the online survey, you will see a thank you message confirming that we have successfully received your information, and we will contact you via your preferred method (phone or email). We will never ask for your financial, credit, or bank account information. We will never ask for an ID number over the phone. Depending on the number of people who have expressed interest in the study,it may take a couple of days before study staff contacts you.
Does COVID-19 only affect people from certain racial or ethnic groups?
COVID-19 can affect anyone, regardless of their race or ethnicity. However, data has shown that it is disproportionately impacting Black, Latinx, and Native American populations. This is largely due to factors such as poverty, poor housing conditions, challenges with accessing medical care, and limited resources, among others.
What is the COVID-19 Prevention Network (CoVPN)?
The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH) to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the networks to address the pressing need for vaccines and monoclonal antibodies (mAbs) against SARS-CoV-2. UCSD is part of this network, and has been selected to conduct COVID-19 clinical trials in Southern California (in San Diego and Imperial Valley counties). You can learn more about the national CoVPN by visiting their website: https://www.coronaviruspreventionnetwork.org/.
Who will have access to an approved vaccine?
Operation Warp Speed, a program of the US government, is working to purchase enough COVID-19 vaccines to provide universal coverage for the country. There are 5 major vaccines being tested in US government-funded studies. 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 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, the Black/African American, Latinx, and Native American populations.
What happens if I get injured during the study?
If you are injured as a direct result of participating in this study, El Centro Regional Medical Center will ensure that you are provided with the necessary medical treatment. The costs of the treatment may be covered by the hospital or the study sponsor, or billed to you or your insurer just like other medical costs, depending on a number of factors. The hospital and the sponsor do not normally provide any other form of compensation for injury. For more information about this, you may contact the ECRMC Vaccine Trial Hotline at (760) 339-4085 or firstname.lastname@example.org