Posted by Michael Wonder on 07 Sep 2022
FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough therapy designation from the US FDA for the prevention of invasive Group B Streptococcus disease due to the vaccine serotypes in newborns and young infants by active immunisation of their mothers during pregnancy.
The FDA decision is informed by the interim analysis of a placebo-controlled Phase 2 trial, evaluating the safety and immunogenicity of GBS6 in healthy pregnant women aged 18 to 40 years, who were vaccinated during the second or early third trimester of pregnancy.
