The Brilliance of Public and Private Sector Collaboration

As the world adjusts to the ever-evolving “new normal” of daily life amid the COVID-19 outbreak, scientists at NIH’s National Institute of Allergy and Infectious Disease (NIAID) have been energetically collaborating with private sector researchers in a race to develop an investigational vaccine designed to protect against COVID-19. Vaccines and treatments are both important elements of a robust and effective response to COVID-19, and the vaccine is especially important for the patient populations that are most vulnerable to the virus.

This fusion of talent, purpose and teamwork has produced an investigational vaccine for a disease that was unknown to doctors and biomedical researchers a few months ago. On March 16, the world’s first COVID-19 vaccine clinical trial was launched with the first participant receiving the investigational vaccine in a Phase 1 trial. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine. Although this is the first of many steps, it offers a glimpse of what is possible when the brilliance of the public and private sector is collectively harnessed.

“This Phase 1 study, launched in record speed is an important first step…” said NIAID Director Anthony S. Fauci, M.D. The investigational vaccine has shown promise in animal models; this next step examines it in humans. The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in humans.

At this phase, study participants, 45 healthy adults between ages 18-55, will receive two doses of the vaccine about 28 days apart. They will return for follow-up visits between vaccinations and for a year after the second shot. Investigators will test blood samples of trial participants to identify and measure the immune response to the experimental vaccine. The clinical trial protocol is rigorous and methodical with patient safety central to each phase.