Breakthrough Therapy designation for Pfizer's novel RSV vaccine

3 March 2022
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Boosting its new and growing focus on vaccines, Pfizer (NYSE: PFE) has received Breakthrough Therapy designation for its respiratory syncytial virus (RSV) vaccine candidate.

The US Food and Drug Administration has granted the designation to PF-06928316, which already has Fast Track status, for prevention of RSV-associated respiratory tract illness in infants.

The novel therapy protects unborn babies from RSV by active immunization of pregnant women. The virus can represent a serious threat for young infants, particularly before the respiratory system has developed fully.

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