Pfizer's Trumenba Vaccine Approved By European Commission

Pfizer Inc. (NYSE:PFE) announced that its Trumenba vaccine received approval from the European Commission (EC) for active immunization of people aged 10 years and older for the prevention of invasive disease caused by Neisseria meningitidis serogroup B (MenB).

Shares of Pfizer have underperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has lost 1.5% during the period, while the broader industry witnessed an increase of 9.1%.

The marketing authorization will enable Pfizer to commercialize the vaccine in all European Union (EU) member states, along with Iceland, Liechtenstein and Norway.

The vaccine is already marketed in the U.S.

Coming back to the news, the European approval was based on data from a clinical development program, evaluating more than 20,000 adolescents and adults. The data from the study demonstrated established safety profile for Trumenba, which works by inducing protective serum bactericidal antibody responses to diverse MenB test strains.

The drug has both two- and three-dose schedules, which help in administration of the vaccine based on individuals’ risk of exposure and susceptibility to MenB. According to the press release issued by Pfizer, nearly 60% of the meningococcal disease cases in Europe were caused by serogroup B. Meningococcal disease is often difficult to diagnose and distinguish from less serious and common diseases such as flu. Despite treatment with the available antibiotics, around 10% - 15% of the patients die with 3% - 5% of the survivors suffering from physical and mental disabilities.

With the approval of Trumenba, Pfizer’s Meningococcal Vaccines portfolio now includes vaccines to immunize people against five of the most common disease-causing meningococcal serogroups in this region.

The vaccine will pose strong competition to GlaxoSmithKline plc’s (NYSE:GSK) Serogroup B meningococcal vaccine Bexsero.

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Zacks Rank & Key Picks

Pfizer currently carries a Zacks Rank #3 (Hold). Stocks worth considering in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . VIVUS sports a Zacks Rank #1 (Strong Buy) while Regeneron carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all the four trailing quarters with an average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.17 to $10.52 for 2017 and from $10.90 to $12.10 for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.

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