FDA has granted Pfizer’s (NYSE:PFE) investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, Breakthrough Therapy Designation.
The designation covers active immunization of mothers during pregnancy to confer protection against invasive GBS disease in newborns and young infants.
GBS disease can result in lifelong neurologic impairments or death, according to a 2019 article in the Journal of Infectious Diseases.
The six most common GBS serotypes cause approximately 98% of GBS disease globally.
Group B streptococcus has been the most common cause of sepsis in newborns since the 1970s, according to the CDC.
The incidence of group B streptococcus has also risen in nonpregnant adults in recent decades, according to a 2019 study published in JAMA. In adults, chronic conditions such as obesity and diabetes may be associated with an elevated risk of contracting GBS.
The FDA’s recent decision is based on data from an…