COVID-19 Pfizer Vaccine Clinical Trial
As of March 2020, the FDA issued an emergency use authorization (EUA) for three vaccines against the virus that causes COVID-19. The FDA issued an EUA for the Pfizer COVID-19 vaccine in December 2020. 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. Globally, more than 44,000 people at over 150 sites around the world volunteered for this study, including 463 Native American people. The Johns Hopkins Center for American Indian Health joined the study in September and 277 people volunteered to participate. Study participants will continue to be followed for up to two years after enrollment.
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 COVID-19 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 can be produced faster and in greater quantity than other types of vaccines.
Side effects of this vaccine are similar to other licensed vaccines and are generally mild to moderate. The most common side effects included pain where the shot was given, tiredness, muscle aches and headache, and these went away after one to two days. The only severe solicited adverse event that were reported by ≥2% of vaccine recipients in the study were fatigues at 3.8% after the first or second dose and headache at 2.0% following dose 2. Results of the primary efficacy analysis found that after two doses, that vaccine was 95% effective against COVID-19 among adults.
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.
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 were eligible to volunteer for this study. Participation is entirely voluntary. People who completed an informed consent process were evaluated for eligibility by a study physician. Eligible participants were assigned at random to receive two doses of the study vaccine or a placebo, three weeks apart. Participants will have a total of approximately 6-8 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 in the study who originally received placebo have been offered the Pfizer COVID-19 vaccine through the study.
All participants have been offered to receive the vaccine under the EUA.
|Answers to Frequently Asked Questions||Community Engagement|
People interested in learning more about the study can call one of our study site locations at the following numbers:
Whiteriver, AZ: (928) 338-5215
Chinle, AZ: (928) 674-5051
Gallup, NM: (505) 722-6865
Shiprock, NM: (505) 368-4030
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.