Infectious Disease Control
Pfizer COVID-19 Vaccine Clinical Trial
There are no licensed vaccines against the virus that causes COVID-19 and finding safe and effective vaccines is critical to protecting families and ending the pandemic. This study aims to evaluate whether an investigational vaccine candidate, created by Pfizer/BioNTech, is effective in preventing COVID-19 disease. Investigational means that the study vaccine has not be licensed by the FDA, but the FDA has approved the use of the vaccine for this study. This trial aims to enroll approximately 44,000 people at over 150 sites around the world. The Johns Hopkins Center for American Indian Health is enrolling eligible volunteers in this study in several communities in the southwest U.S.
Native American communities have experienced among the highest rates of COVID-19 disease and death in the U.S., while remaining the least represented in studies of interventions that can prevent or treat COVID-19. Providing an opportunity for Native American individuals to participate in clinical trials helps to ensure that the vaccines that are licensed and recommended for use in the U.S., will be effective for the communities that need them the most.
About the vaccine
The Pfizer/BioNTech investigational vaccine is a mRNA vaccine and does not contain live virus. mRNA is the code that tells our cells what proteins to build. This vaccine tells cells to build the outside spike protein of coronavirus so that the body reacts and produces antibodies. This prepares the body to fight the real coronavirus. RNA vaccines are made from synthetic (laboratory made) pieces copied from the coronavirus, SARS-CoV-2, not the whole virus. The vaccines cannot cause infection. They are also much quicker and simpler to make than conventional vaccines, which means that they could be produced faster and in greater quantity than other types of vaccines. In studies conducted to date, this vaccine has been shown to cause side effects that are similar to other licensed vaccines (e.g., temporary swelling or soreness at the injection site, fever, fatigue, headache, muscle/joint pain). The vaccine has also been shown to induce a strong immune response, suggesting that it could protect people against COVID-19 disease.
The severity of this global COVID-19 crisis has led to an unprecedented investment in vaccine development. While this process is moving quickly, it’s important to know that no steps are being skipped. The FDA will only license a vaccine once it is shown to be safe and effective.
About the study
Following consultation with healthcare providers, elders, and other community leaders, this study was submitted to the Navajo Nation Human Research Review Board (NNHRRB). The NNHRRB reviewed and approved this study, as did the Johns Hopkins Institutional Review Board. Adults 18-85 years of age, who are healthy or have stable underlying medical conditions, and who have not had a prior COVID-19 infection may volunteer for this study. Participation is entirely voluntary. People who complete an informed consent process will be evaluated for eligibility by a study physician. Eligible participants will be assigned at random to receive two doses of the study vaccine or a placebo, three weeks apart. Participants will have a total of 6 visits over a two-year period. Study staff will collect blood samples to test for antibodies to COVID-19. In addition, participants will complete a weekly diary to monitor for side effects or illness. No other testing of specimens, beyond what is specifically stated at the time of enrollment, is allowed. No genetic testing will be done.
People interested in learning more about the study can email: email@example.com.
Johns Hopkins Center for American Indian Health’s history of infectious disease prevention studies
For the past 40 years, Johns Hopkins Center for American Indian Health has worked in partnership with the Navajo Nation, White Mountain Apache Tribe, Indian Health Service and Tribal Health Organizations on studies aimed at reducing disease and improving the health and well-being of Native people. Past studies include three successful Phase 3 clinical trials of vaccines that are now used as part of routine immunizations that all children around the world receive: the Hib vaccine (against a leading cause of meningitis), the Prevnar-7 vaccine (against a leading cause of pneumonia) and the rotavirus vaccine (against a leading cause of infectious diarrhea that can have severe effects in infants). All studies have been done by research personnel who are trained in the conduct of clinical trials, with the guidance of the communities, and with the oversight of the Tribal IRBs.