Expanded Access Policy
Group B Streptococcus (GBS)
Group B Streptococcus (GBS) is a common commensal colonizing some 20% of pregnant women. GBS colonization may lead to adverse pregnancy outcomes and is the leading cause of life-threatening infections in newborn babies during the first 3 months of life. It is estimated to be responsible for some 320,000 cases of neonatal invasive disease, 60,000 stillbirths, 3,500,000 preterm deliveries, and 10,000 babies suffering from long-term neurological damage annually world-wide.
The National Institute of Health of the US has identified prevention of GBS in newborns as a major vaccine objective, but so far, no approved or universally useful vaccine exists. Current intervention involves the use of vast quantities of prophylactic antibiotics given to birthing women, which has resulted in the emergence of wide-spread antibiotic resistance and may impact the development of the neonate’s gastrointestinal microbiome.
A vaccine effective against relevant strains of GBS, is poised to have both a great medical and pharmacoeconomical impact if administered universally to pregnant women.
MinervaX understands the intent of expanded access programs but, at this time, we can best advance the development of our promising vaccine against GBS by enrolling patients in clinical trials, which are designed to provide the data to facilitate regulatory approval and marketing of the vaccine; thus, allowing access for the broader patient community. Our priority is to demonstrate the safety and effectiveness of GBS-NN/NN2 Vaccine, in an appropriately designed and robust clinical trial program.
MinervaX is currently unable to offer expanded access for GBS-NN/NN2 Vaccine and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational vaccine.