Pfizer’s PF-06760805 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Infection in Infants
Shots:
- The US FDA has granted BTD to GBS6 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 US FDA’s decision was based on an interim analysis of a P-II study evaluating the safety and immunogenicity of GBS6 in healthy pregnant women aged 18 to 40yrs. who received their vaccinations in the second or early third trimester of pregnancy across South Africa, the UK, and the US
- The company is pursuing a clinical development strategy in high-, middle-, and low-income countries to make a developed vaccine as fast as feasible available globally
Ref: Pfizer | Image: Pfizer
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
