Long on the sidelines of pharma R&D, vaccine development is moving to center stage as most of the big pharmas diversify, spreading
their risk among the full gamut of revenue sources. And it helps that the vaccine market—$22 billion in 2009—is growing at
an annual rate of 10 percent, reaching $35 billion by 2014, according to a new Kalorama Information report. Vaccines are also
cost-effective: Every dollar spent on vaccination returns between $7 and $20 in avoided costs related to disease management.
The three giants in vaccine development—GlaxoSmithKline, Sanofi-Aventis, and Merck—all have late-stage candidates with enormous
potential to improve health in the developing world.
GSK has spent two decades and $500 million in an effort to create the first vaccine to prevent malaria, the mosquito-borne
parasite that kills more than 1 million children a year, mainly in Africa and Asia. The newest version, Mosquirix, is in early Phase III trials in 12,000 children in seven African countries (4,000 more children are needed for full enrollment).
The first data reports on safety and efficacy are due at the end of the month. In previous trials, Mosquirix achieved a protection
rate of only 45 percent—but given the disease's destructiveness, even partial protection will save the lives of many infants
and young children. Still, Mosquirix must step it up because the Malaria Vaccine Initiative has set the bar at 50 percent
Mosquirix was engineered by fusing a slice of the outer protein of a very deadly malaria parasite type with a slice of Hepatitis
B virus and an adjuvant chemical to boost response. The vaccine requires three injections for optimal protection, but even
a single dose will produce sufficient antibodies to prevent severe disease. Anticipating a review as early as 2012, the British
firm has vowed to make Mosquirix available to any nation that requests it, asking only a 5 percent return on its cost.
Sanofi Pasteur, Sanofi-Aventis' venerable vaccine innovator, has developed the first vaccine apparently potent against all
four serotypes of the dengue fever virus. There is no specific treatment for dengue, and some 2 million children every year
suffer a severe infection, especially in Latin America and Asia. The French firm is so confident in the data coming from its
global Phase III trials that it has already broken ground on a $500 million manufacturing plant for the blockbuster-to-be
ChimeriVax set to launch in 2014.
Merck is developing a vaccine, V710, against Staphylococcus aureus licensed from Intercell and based on an antigen found on almost all types of the bacteria.
S. aureus is the leading cause of hospital-acquired infections, and almost half of its strains are resistant to available
antibiotics. V710's potentially broad spectrum approach may prove sufficiently effective as to make it the first vaccine against
the superbugs. New data from a Phase II study of 200 patients with end-stage renal disease undergoing hemodialysis—and therefore
at high risk of infection—confirmed that V710 induced a sustained immune response.
Novartis' anti-meningitis B candidate is another vaccine with very broad antibody coverage. 4CMenB confers protection against most of the geographically and genetically diverse strains of the meningitis B bacteria, including
85 percent of adults and 75 percent of children. The Swiss firm is donating its meningitis B assay platform worldwide in order
to speed detection of culprit strains susceptible to the vaccine, which is expected to roll out in 2013.
Bavarian Nordic, the Danish vaccine specialty shop, is building up its biodefense portfolio with Immavune, a novel Phase III vaccine for smallpox that shows exceptional safety, even in the immune-compromised. It aims to combine
Immavune with MVA-BN, a novel preclinical candidate against anthrax, to provide populationwide protection against two of the
top bioterrorist threats.