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The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to an investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 (hexavalent anti capsular polysaccharide/cross reactive material 197 glycoconjugate) 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 investigational maternal vaccine is designed to protect against the 6 most prominent GBS serotypes. The designation was supported by an interim analysis of an ongoing, placebo-controlled phase 2 study (ClinicalTrials.gov Identifier: NCT03765073) evaluating the safety and immunogenicity of a single intramuscular injection of GBS6 in healthy pregnant women 18 to 40 years of age who were vaccinated during the second or early third trimester of pregnancy. Study results will be published once completed.
“If approved for pregnant women, GBS6 could help protect newborns from the serious illnesses caused by this disease like meningitis, pneumonia, and sepsis – fulfilling a critical global public health need,” said Annaliesa Anderson, PhD, Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are encouraged by today’s decision and look forward to discussing GBS6 with the FDA and other regulatory agencies to potentially reduce neonatal deaths and positively impact the existing global disease burden of GBS.”
The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy.
Reference
FDA grants Breakthrough Therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunization of pregnant women. News release. Pfizer Inc. Accessed September 7, 2022. https://www.businesswire.com/news/home/20220907005486/en/FDA-Grants-Breakthrough-Therapy-Designation-to-Pfizer%E2%80%99s-Group-B-Streptococcus-Vaccine-Candidate-to-Help-Prevent-Infection-in-Infants-Via-Immunization-of-Pregnant-Women
This article originally appeared on MPR
