Clinical Trials FAQ
Quick Questions And Answers About COVID-19 Clinical Trials.
At this time there is no vaccine to prevent coronavirus disease 2019 (COVID-19). The FDA is working with vaccine developers and other researchers and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies, and drugs to prevent COVID-19.
Yes, you are allowed to get a flu shot 14-28 days after your last study vaccine.
Participating in the study and receiving the vaccine will not cause you to get your family members sick. However, you still will need to follow State & Government guidelines to decrease the transmission of the virus.
No, this type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.
Some participants will receive a study vaccine and/or a placebo. If you receive a study vaccine, this is still a study and we are trying to determine the effectiveness of the vaccine. You should still follow guideline and practice social distancing.
Yes, you can still participate in the vaccine study as long as the panel/questionnaire study you are participating in does not provide any type of COVID related treatment
In general, respiratory viruses are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus.
Per FDA guidelines, any experimental vaccine requires clinical testing in various phases to establish safety and efficacy before regulatory agencies will consider approval for use in the general public. In addition, many vaccine doses will have to be produced to enable broad availability which requires large scale manufacturing over time. Normally, the process of approval and production takes years, however strategies are being accelerated, while maintaining the integrity of the process to ensure the safety of subjects.