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FDA grants GBS6 vaccine breakthrough therapy designation

After promising outcomes in an ongoing phase 2 trial, the FDA has given Pfizer’s GBS6 vaccine Breakthrough Therapy Designation against Group B Streptococcus in infants.

The US Food and Drug Administration (FDA) has given the GBS6 (PF-06760805; Pfizer) vaccine Breakthrough Therapy Designation for use in pregnant women to help infants avoid Group B Streptococcus (GBS) infection.

The vaccine leads to active immunization in mothers, giving their infants vaccine serotypes and protecting them from GBS. The safety and immunogenicity of GBS6 has been tested in pregnant women aged 18 to 30 years in a phase 2 study, where the vaccine was administered during the 2nd or 3rd trimester. This study is ongoing, and Pfizer plans to publish the results upon the study’s completion.

“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 and Development at 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.”

GBS6 can protect infants from the 6 most common GBS serotypes, which make up 98% of diseases worldwide. GBS can lead to severe infections in infants such as sepsis, pneumonia, and meningitis. About 1 in 4 women carry GBS bacteria which can be passed to their infants. There are about 410,000 infections per year, causing about 147,000 stillbirths and infant deaths.

In the ongoing phase 2 study, GBS is being tested for the safety and immunogenicity of a single dose through intramuscular injection. Studies are being conducted in high-, middle-, and low-income countries so that the vaccine can be available worldwide as soon as possible.

FDA grants breakthrough therapy designation to pfizer’s group b streptococcus vaccine candidate to help prevent infection in infants via immunization of pregnant women. Business Wire. September 7, 2022. Accessed September 22, 2022.