The FDA granted Pfizer a breakthrough therapy designation for its group B Streptococcus vaccine candidate for pregnant people to prevent GBS disease in newborns based on its ongoing phase 2 trial.
GBS infections are most prevalent among newborns, and of 2,000 or so infants who contract the disease, 4 to 6 percent die, according to the CDC. And about 25 percent of pregnant people have the capacity to pass on the bacteria to their infant, Pfizer said in a Sept. 7 news release.
The vaccine candidate, named GBS6, "could help protect newborns from the serious illnesses caused by this disease like meningitis, pneumonia and sepsis," Annaliesa Anderson, PhD, Pfizer's senior vice president and head of vaccine research and development, said in the statement. "[A GBS vaccine is] a critical global public health need."