Novavax releases positive results of phase 2 RSV F-protein vaccine clinical trial
"It's increasingly appreciated that RSV causes an enormous amount of illness on an annual basis, particularly in the older population,” Dr. William Schaffner, professor of preventive medicine and infectious diseases, Vanderbilt University Medical Center, said. “An RSV infection can predispose older adults to developing secondary pneumonia and admission to the hospital. Each year in the United States, approximately 14,000 people ages 65 or older die of RSV infections and approximately 900,000 have some sort of medical encounter with a doctor, or emergency room, or are hospitalized. Prevention remains the highest goal of medicine and those of us in preventative medicine and public health would like to prevent as many of these infections as possible."
The purpose of the study was to determine the safety and efficacy of the vaccine.
"These efficacy data represent a historic advance for the field," Gregory Glenn, M.D., senior vice president, Research and Development, said. "This is also an important confirmation of the burden of RSV disease in older adults and highlights the high rate of lower respiratory tract symptoms in those infected by RSV in a large, prospective trial. It is clear that our RSV F Vaccine provided statistically significant efficacy in older adults, a population that historically has been difficult to protect. The reduction in symptomatic RSV, RSV with lower respiratory tract illness and RSV associated with difficulty breathing are breakthrough results. We look forward to making details of these data public at an appropriate forum in the future."
The results show that it is the first RSV vaccine that has shown any effectiveness in any population. Its statistics show significant effectiveness in preventing older adults from contracting symptomatic RSV disease.
"The development of an RSV vaccine has been a decades-long challenge," President and CEO Stanley C. Erck said. "We are thrilled by the groundbreaking efficacy of our RSV F Vaccine in older adults. We are committed to pursuing an aggressive developmental timeline for this program which includes discussions with regulatory authorities and initiation of a pivotal Phase 3 trial as early as the fourth quarter of this year. We also expect to announce safety and immunogenicity data from the RSV F Vaccine Phase 2 trial to protect infants via maternal immunization later this quarter."