The company released the results from the second stage of the Phase I/IIa human clinical trial of its virus-like particle (VLP) vaccine against H5N1 avian influenza and said it appeared to work as well as other vaccines.
Novavax's VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain that emerged in humans in Indonesia in 2005, and has infected at least 135 humans, 81% of whom have died.
"These results are strong and very competitive and they compare well with any vaccine against pandemic flu, whether licensed or in development," Novavax President and Chief Executive Officer Dr. Rahul Singhvi said in a conference.
The study evaluated at least 160 individuals who received two injections, in doses ranging from 15 micrograms (mcg) to 90 mcg or placebo. All subjects tested negative for neutralizing antibodies to the H5N1 A/Indonesia strain at the beginning of the study. At the highest dose, the vaccine produced a response against one version of the lethal H5N1 bird flu in 94 percent of patients, while no responses were observed among individuals who received a placebo.
Novavax is developing avian flu vaccines that it hopes will interrupt and/or halt a pandemic in time. Novavax has collaborated with GE Healthcare, a unit of General Electric Company, to advance a new flu vaccine that could be swiftly produced in large quantities.
Most influenza vaccines use either a weakened but live flu virus or a killed virus to stimulate the human immune system
define, while Novavax vaccine is concentrated around three proteins found in flu viruses: the neuraminidase (N), the M1 protein, and hemagglutinin, the one common vaccines battle against most of the time.
The traditional vaccines must be reformulated every year to match the constantly mutating flu strains, and take months to make using specially grown live chicken eggs. Novavax's process, which uses insect-cell cultures, an produce seven to 10 times as much vaccine in the same time as techniques that rely on eggs or cells from mammals.
"These data are exciting because they demonstrate that recombinant VLPs are a valid and potent vaccine approach against influenza. Combined with our innovative manufacturing approach, our VLP vaccine candidate has the potential to address an unmet need in pandemic influenza preparedness efforts being planned by health authorities around the world," Singhvi said.
The clinical stage biotechnology company’s VLP vaccine can be an effective and affordable tool of a pandemic solution that can help countries that lack sufficient production of the vaccines protect people against the flu pandemic in time.
Influenza A virus subtype H5N1, also known as A(H5N1) or H5N1, is a subtype of the Influenza A virus that is capable of causing illness in many animal species, including humans.
A bird-adapted strain of H5N1, called HPAI A(H5N1) for "highly pathogenic avian influenza virus of type A of subtype H5N1", is the causative agent of H5N1 flu, commonly known as "avian influenza" or simply "bird flu", and is endemic in many bird populations, especially in Southeast Asia.
According to the World Health Organization's most recent data, the lethal H5N1 virus has infected more than 385 people and killed 243 (as of June 19) of them since the virus re-emerged in Asia in 2003.
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