Novavax, Inc. (NASDAQ:NVAX) recently announced positive results from the ongoing phase 2 safety and immunogenicity clinical trials of the RSV F Vaccine in older adults. The new data on the preclinical trials in older adults (E201 and E301) together with additional findings from the phase 3 clinical trials of the vaccine for infants through maternal immunization have shown that the RSV F Vaccine is safe and well-tolerated among the participants of the study.
The findings from the studies indicate that there is potential protection of infants from risks of contracting the RSV disease. The new data reveals the significant increase in the magnitude, duration and the overall quality of the vaccine immune response.
The Company is also planning to launch the Phase 2 efficacy test in older people by 2018. The topline data from the recent study was intended to assess the safety and immunogenicity of the dose regimen of the vaccine if used with or without the aluminum phosphate or the Matrix-M™ adjuvant. The study was conducted in 300 older adults where participants were vaccinated outside the RSV season to examine their response in relation to the RSV F antigen.
The findings support the presence of the adjuvant formulations of the vaccine in the older adult trials and the results were purportedly safe and well-tolerated among the group. Previous studies in the protein structure and immune system have led to new understanding of the structure and immune responses as revealed by the company’s RSV F antigen. The findings confirm that the new vaccine as highly effective immunogenic antigen with potential to protect the individuals from the RSV disease.
If approved, the vaccine would resolve the long unmet medical requirement and will significantly reduce the healthcare cost burden for the patients. Novavax is also preparing to launch another Phase 2 efficacy trial in 2018 to examine the chronic obstructive pulmonary disease (CORP) exacerbations as the potential final point for RSV older adult program.
Furthermore, the Phase 3 trial for the RSV F Vaccine for infants through the maternal immunization also shows a positive progress into its third global season of enrollment.