Pfizer Gets FDA Breakthrough Therapy Designation For GBS Vaccine Candidate

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s PFE lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.

The regulatory grant is supported by the interim analysis of a placebo-controlled Phase 2 study 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.

Annaliesa Anderson, Senior Vice President and Head of Vaccine Research & Development, commented: "GBS infections can have a devastating effect on newborns and their families. While prenatal screening and antibiotics during childbirth help provide protection against GBS in developed countries, this approach is not fully protective in the first week of life; presents multiple challenges in low- and middle-income countries; and has not been shown effective in preventing disease globally in infants beyond the first week of life and through the vulnerable first three months of life.”

Hexavalent anti capsular polysaccharide (CPS) / cross reactive material 197 glycoconjugate (GBS6) is an investigational maternal vaccine being developed to help prevent invasive Group B Streptococcus (GBS) in newborns.

The FDA grants Breakthrough Therapy Designation to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions.

Price Action : Pfizer shares closed Tuesday’s trading at $45.76.