Pfizer has received the US Food and Drug Administration (FDA) Breakthrough Therapy Designation for its Group B Streptococcus (GBS) vaccine candidate, GBS6 (PF-06760805).

The vaccine is indicated for the prevention of invasive GBS disease in newborns and young infants, through active immunisation of their mothers during pregnancy.

GBS is a common bacterium responsible for potentially severe diseases in infants, including sepsis, pneumonia and meningitis, during the first three months of life.

Pfizer designed its investigational vaccine candidate GBS6, to offer protection against the six most dominant GBS serotypes, which account for 98% of disease worldwide.

The granting of breakthrough designation follows the FDA’s decision to grant Fast Track status to GBS6, announced in March 2017.

The FDA’s breakthrough designation is based on interim analysis of an ongoing Phase 2 study, evaluating the safety and immunogenicity of GBS6 in healthy pregnant women.

The data was from pregnant women aged 18 to 40 years, who were vaccinated during the second or early third trimester of pregnancy.

Pfizer senior vice president and vaccine research and development head Annaliesa Anderson said: “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.”

According to Pfizer, prenatal screening and antibiotics during childbirth help provide protection against GBS in developed countries.

However, it is not fully protective in the first week of life, and is associated with multiple challenges in low- and middle-income countries.

In addition, the approach is not proven to be effective in preventing disease in infants beyond the first week, and through the first three months of life.

If approved, its GBS6 could help protect newborns from the serious illnesses caused by the disease like meningitis, pneumonia, and sepsis, said Pfizer.

The company aims to launch a clinical development strategy in high-, middle- and low-income countries, to make the vaccine available as soon as possible.

In April this year, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has granted PRIME designation for GBS6.