Pharmaceutical giant Pfizer (NYSE: PFE) announced positive top-line data from the Phase 3 clinical trial of its RSV vaccine candidate, RSVpreF, or PF-06928316. The vaccine, given to pregnant women, helps protect their infants from RSV disease after birth.
RSV, or respiratory syncytial virus, is a contagious virus and a common cause of respiratory illness and hospitalizations, and sometimes deaths, in infants.
The Phase 3 clinical trial, known as MATISSE, enrolled 7,400 pregnant women who were given RSVpreF or placebo between the late second and third trimesters of their pregnancies.
The study achieved an efficacy of 81.8% against severe medically attended lower respiratory tract (MA-LRTI) illness due to RSV in infants from birth through the first 90 days of life. Further, a high efficacy of 69.4% was noted in infants over the first six months.
The vaccine was well-tolerated without any safety concerns for both vaccinated mothers-to-be and their newborn babies. Pfizer plans to submit its first regulatory application to the FDA for approval by the end of 2022.
If approved, Pfizer’s RSV vaccine candidate could be the first-ever maternal vaccine that will help prevent potentially life-threatening respiratory illness in young infants.
However, the company stated that the statistical success criterion was not met for the second primary goal. However, a clinically meaningful efficacy of 57.1% was noted for MA-LRTI in infants from birth through the first 90 days of life. Further, a 51.3% efficacy for MA-LRTI was observed over the six-month follow-up period.
Separately, yesterday, Pfizer reported upbeat Q3 results, with adjusted earnings soaring 40% year-over-year to $1.78 per share, beating analysts’ estimates of $1.39. Q3 revenues declined 6% year-over-year to $22.6 billion but exceeded Street estimates by $1.5 billion.
Is PFE a Buy or Sell?
As per TipRanks, analysts are cautiously optimistic about the Pfizer stock and have a Moderate Buy consensus rating, which is based on three Buys and eight Holds. Pfizer’s average price forecast of $51.55 implies 7.37% upside potential.
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