(CercleFinance.com) – Pfizer announced on Wednesday that it had obtained breakthrough therapy designation from the US FDA for its Streptococcus B vaccine intended to prevent infections in infants by vaccinating pregnant women.
In a statement, the biopharmaceutical giant points out that the use of GBS6 could protect newborns against serious diseases such as meningitis, pneumonia and sepsis, thus meeting a global medical need.
‘Innovative therapy’ status aims to speed up the development and regulatory process of drugs intended to treat serious or life-threatening diseases.
The GBS6 vaccine project had already obtained ‘fast track’ status from the FDA in 2017, designed to accelerate the development of drugs that have demonstrated the potential to meet unmet medical needs related to serious or fatal pathologies.
Following this information, Pfizer shares rose 0.7% on Wednesday morning on the New York Stock Exchange, compared with an increase of less than 0.3% for the Dow Jones index.
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