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Pfizer (PFE) has received approval from the U.S. Food and Drug Administration (FDA) for its Pneumococcal 20-valent Conjugate vaccine, PREVNAR 20, for preventing invasive pneumococcal disease and pneumonia in adults aged 18 and above.
Following this approval, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will be meeting in October to evaluate and update recommendations for the safe and appropriate use of the vaccine in adults.
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer, said, “Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines.” (See Pfizer stock analysis on TipRanks)
Jansen added, “With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”
The approval is based on data from clinical studies in adults which included Phase 1 and 2 and three Phase 3 trials. Over 6,000 adult subjects participated in the three Phase 3 trials. This data helped describe the safety and evaluate the immunogenicity of the vaccine.
Significantly, PREVNAR 20 adds seven serotypes to Pfizer’s PREVNAR 13 vaccine. These seven serotypes account for about 40% of the total pneumococcal disease cases and fatalities in the U.S.
On June 1, Argus Research analyst David Toung reiterated a Buy rating on the stock and a $55 price target (41.6% upside potential).
Toung believes the market is not fully appreciating the sustainability of the COVID-19 vaccine franchise and its contribution to Pfizer’s top line beyond 2021.
Based on 2 Buys and 10 Holds, consensus among analysts is a Hold. The PFE average analyst price target of $44.08 implies 13.5% upside potential.
Shares have gained about 13.3% over the past year.