The public now knows exactly how many infections these COVID-19 trials are planning for—and how many would trigger an interim analysis of early data. In an unprecedented but much-applauded move, the leading vaccine companies have released detailed trial protocols.
Johns Hopkins Center for Immunization Research Begins Enrollment for Pfizer/BioNTech Phase 2/3 COVID-19 Vaccine Research Trial
The Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health has begun enrolling study participants into a Phase 2/3 COVID-19 vaccine trial sponsored by BioNTech in collaboration with Pfizer.
How Close are we to a Safe, Effective COVID 19 Vaccine? The COVID-19 vaccine is on track to become the fastest-developed vaccine in history, but that doesn’t mean critical steps are being skipped. Ruth Karron, who leads the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, is one of the […]
The CIR and local African American and Latinx community leaders are working together to ensure that these populations, which are at higher risk of COVID-19 related hospitalization and death, are well informed about the important role that licensed COVID-19 vaccines will play in reducing the spread of the virus.
This article underscores the importance of cautious optimism regarding the positive early results for Phase I COVID-19 clinical vaccine trials. Drs. Ruth Karron and Kawsar Talaat say that data from upcoming Phase III trials is necessary to determine whether the early data can be validated in larger numbers of vaccine recipients.
Decisions may need to be made about issuing EUAs for one or more vaccines, with data that are promising but incomplete. Questions about risk and benefit, either for entire populations or for high-risk subgroups, must be discussed openly, among independent experts, using all available data, with clear acknowledgment of what is known and what is as yet unknown. Decisions about licensure of COVID-19 vaccines should similarly be made with VRBPAC engagement, review, and advice.
COVID-19 Prevention Network (CoVPN) Website is Live The COVID-19 Prevention Network (CoVPN) has launched an interactive website to provide information about Phase 3 vaccine and monoclonal antibody efficacy studies for the prevention of COVID-19. The site, launched on July 8, 2020 educates potential study participants about COVID-19, what to expect when volunteering in clinical trials […]