In a move that creates a new layer of competition among vaccine makers, the FDA on Feb. 22 approved Novartis' Menveo vaccine to prevent four strains of invasive meningococcal disease in people 11 to 55 years old.

Novartis expects to launch Menveo next month in the U.S., where it will compete with Menactra (meningococcal vaccine) from Sanofi-Aventis. Like Menactra, Novartis' Menveo fends off the A, C, Y and W-135 serotypes and targets 11- to 55-year-olds, although neither vaccine can prevent serotype B, which is the most prevalent strain to attack infants and toddlers Also see "One More Shot? The ACIP Continues Its Review Of Meningitis Vaccines" - Pink Sheet, 22 February, 2010.).

This is significant because about 60 percent of the cases that afflict these youngest children are attributed to serotype B, and this age group represents the biggest market opportunity in the U.S., according to Wall Street analysts.

Coincidentally, the approval comes just as the CDC's Advisory Committee on Immunization Practices meets this week to review the cost effectiveness of meningitis vaccines in infants and toddlers. The meeting is a prelude to determining whether three meningitis vaccines - GlaxoSmithKline is also developing one - should be included on the Childhood Immunization Schedule.

In announcing the Menveo approval, Novartis was quick to note that about 16 million adolescents alone between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease, suggesting that Menveo is capable of generating considerable revenue by serving that segment of the population.

Indeed, since 2005, the ACIP has recommended meningitis vaccination for adolescents, given that the disease can spread quickly in this age group, particularly among those living in such closed quarters as camp bunks, college dormitories and military barracks.

In recent years, the average number of annual cases among adolescents has been between 200 and 250, according to Amanda Cohn, an ACIP working group member and medical epidemiologist with the division of bacterial diseases at the CDC's National Center for Immunization and Respiratory Diseases.

In an e-mail, a Novartis spokesman wrote that the global meningitis market could reach $1.5 billion this year and cited analyst reports forecasting Novartis meningitis vaccine sales could reach $500 million by 2015. The drug maker also cited a report by Zuercher Kantonalbank analyst Michael Nawrath, who estimated sales could reach about $1.5 billion annually, once vaccines can be used for all age groups, including infants and toddlers.

Outcome of advisory committee meeting is "critical"

Novartis, in fact, hopes to win approval to vaccinate the youngest children, but as Sanford C. Bernstein analyst Tim Anderson notes, the ACIP is not likely to add Menveo to the list of recommended vaccines. "The outcome of ACIP [meeting] is going to be critical," he said, "and so far, it isn't exactly looking pretty."

The ACIP working group appears willing to consider issuing only a so-called permissive recommendation, which means the vaccines wouldn't be recommended for placement on the Childhood Immunization Schedule. Instead, vaccination would be left to the discretion of health care providers and parents.

The ACIP is considering this move because of the low incidence rate in recent years - only about 360 cases each year in children under five - and because the three vaccines being reviewed don't address serotype B. Placement on the childhood schedule - a more lucrative opportunity - would depend on the ACIP issuing what is known as an affirmative recommendation, which is routine vaccination.

Menveo is a first step, because as Bernstein sees it, the bigger money will be made by a vaccine that targets serotype B, given that the ACIP may be more likely to add such a vaccine to the Childhood Immunization Schedule. The prospect of routine vaccination of every infant in the U.S. has Anderson forecasting that Menveo could generate $500 million in sales by 2015. Novartis, however, is hedging its bets with another vaccine that targets serotype B in development.

"This is the more important vaccine for them and has the higher value proposition," said Anderson. "I don't know why, under the best of circumstances, this couldn't be another Prevnar (which sold $3 billion globally last year). Over the years, meningitis B could get to be that big."

However, Novartis recently acknowledged that a tolerability issue was found with its serotype B vaccine in Phase II and, more recently, in Phase III clinical trials due to fever. As a result, different formulations are being pursued. Recruitment for pivotal Phase III trials in Europe has been completed, though, and results are expected this year, with regulatory filing in Europe expected by the end of 2010.

"It's not a fever rate that has led to any adverse events that are worrisome. And we are confident that the risk-benefit profile based on what we know today is very positive," said Andrin Oswald, the chief executive of the Novartis vaccines business during a Jan. 26 conference call with analysts to discuss earnings. "Of course, we're looking at other formulations by which we will be able to make the vaccine even better going forward...So to find the right balance - having no fever, but still good protection - is not that easy. But, nonetheless, we are trying."

- Ed Silverman (e.silverman@elsevier.com)

Novartis Wins FDA Approval For Its First Meningitis Vaccine As ACIP Is Set To Meet

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