Pfizer, Inc. PFE announced positive top-line data from a pivotal phase III study. The study evaluated the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in individuals aged between 10 and 25 years.
The pentavalent vaccine is a combination of Pfizer’s two marketed meningococcal vaccines — Trumenba, a meningococcal vaccine for serogroup B and Nimenrix, a conjugal vaccine targeting serogroups A, C, W-135 and Y.
There is no single meningococcal vaccine that targets five meningococcal serogroups (namely A, B. C, W and Y). Presently, the FDA licenses the marketing of two types of vaccines targeting the indication – meningococcal conjugate (MenACWY) vaccines and serogroup B meningococcal (MenB) vaccines.
The study achieved all its primary and secondary endpoints. The study showed that MenABCWY demonstrated non-inferiority compared with licensed vaccines for all five meningococcal serogroups, which are responsible for 96% of all invasive meningococcal disease cases worldwide. The immune responses in study participants who received MenABCWY were also higher than that of the licensed vaccines. MenABCWY’s safety profile was also consistent with the licensed vaccines.
Based on this data, Pfizer plans to submit a biologics license application to the FDA later this year during the fourth quarter seeking approval for MenABCWY.
The licensed vaccines consisted of Trumenba and GSK’s GSK Menveo, which targets serogroups A, C, W-135 and Y. While Pfizer’s Trumenba is approved by the FDA for individuals aged between 10 and 25 years, the primary vaccination with a single dose of GSK’s Menveo is approved for individuals aged 11 through 55 years. The study participants were randomly assigned to receive either two doses of MenABCWY or two doses of Pfizer’s Trumenba plus one dose of GSK’s Menveo.
Shares of Pfizer have lost 22.2% in the year so far compared with the industry’s 3.7% decline.
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Presently, the vaccine recommendations in the United States include receiving four doses of the two licensed vaccines, which provide the broadest protection against meningococcal disease. However, only a small fraction of the population can complete receiving both vaccines. If approved, the pentavalent vaccine will not only simplify the administration process by bringing down the number of doses required for full vaccination but also increase vaccine coverage in the country.
If left untreated, meningococcal disease can either lead to death within 24 hours. If not, then the survivors are left with significant long-term disabilities. The serogroup B accounts for the majority of disease in the United States and Europe.
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Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the overall healthcare sector include Kamada KMDA and Morphic MORF, which sports a Zacks Rank # (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 26.2% in the year-to-date period.
The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 37.7% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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