FDA Grants Breakthrough Therapy Designation to Group B Streptococcus Vaccine Candidate


Decision is based on interim analysis of Pfizer’s GBS6 in healthy pregnant woman aged 18 to 40 years, who were vaccinated during their second or early third trimesters.

The FDA announced breakthrough therapy designation for Group B Streptococcus (GBS) vaccine candidate, GBS6 (PF-06760805; Pfizer) for the prevention of GBS disease because of the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.

“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 3 months of life,” Annaliesa Anderson, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a statement.

The decision was based on the interim analysis of a placebo-controlled phase 2 study (NCT03765073), which evaluated the immunogenicity and safety of GBS6 in healthy pregnant women aged 18 to 40 years, who were vaccinated during their second or early third trimesters.

This study is ongoing, and Pfizer will publish the outcomes when the trial is completed.

GBS6 is designed to offer protection against 6 of the most prominent GBS serotypes. The ongoing phase 2 study is being conducted in pregnant women and their infants in South Africa, the United Kingdom, and the United States.

Pfizer is also pursuing clinical development strategies in high-, middle-, and low-income countries, hoping to make a successfully developed vaccine available globally and quickly.

“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,” Anderson said.

The FDA assigns breakthrough therapy designation to expedite the development and review of drugs and vaccines that are intended to prevent or treat serious conditions. The preliminary evidence should support the improvement of the drug or vaccine over available therapies on a clinically significant endpoint.

This decision follows the FDA’s decision to grant fast-track status to the vaccine in March 2017. Fast-track status helps facilitate the development and review of new drugs and vaccines that are intended to prevent or treat an area of unmet medical need.

In April 2022, GBS6 was also granted PRIME designation by the European Medicines Agency’s Committee for Medicinal Products for Human Use, which supports the development of medications that target an unmet medical need.


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. September 7, 2022. Accessed September 7, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-breakthrough-therapy-designation-pfizers-group-b

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