Pfizer secures USFDA Breakthrough Therapy designation for Group B Streptococcus Vaccine
Group B Streptococcus (GBS) is a common bacterium that can cause potentially devastating diseases in infants, including sepsis, pneumonia and meningitis, during the first three months of life.;
New York: Pfizer has recently announced that the company's investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (USFDA) 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. GBS6 is designed to offer protection against the six most prominent GBS serotypes, which account for 98% of disease worldwide.
The USFDA decision is informed by the interim analysis of a placebo-controlled Phase 2 study (NCT03765073), 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. The study remains ongoing, and Pfizer will publish outcomes from this clinical trial when it is completed.
"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," said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "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. 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."
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.