Researchers led by Gary Nabel, the former director of the Vaccine Research Center at the NIH’s National Institute of Allergy and Infectious Diseases, fused a protein called hemagglutinin, on the surface of the virus, to ferritin, another protein that carries iron in the blood, creating a new type of nanoparticle that elicited broader and more potent immunity than products sold by Sanofi and Novartis AG (NOVN), according to the study, published online today in the journal Nature.
The result may point the way toward a so-called universal vaccine that can be used against different viruses even as they mutate to evade the immune system, said Nabel, who was last year appointed chief scientific officer at Paris-based Sanofi (SAN), one of the world’s biggest vaccine makers.
The experimental product is “taking us probably several steps down the road towards the universal flu vaccine,” Nabel said in a telephone interview yesterday. It also “may have more diverse applications. We don’t have to limit ourselves to influenza.”
Flu viruses can mutate rapidly, creating threats faster than current technology makes new vaccines. Between 1976 and 2006, flu caused annual deaths ranging from a low of about 3,000 to a high of about 49,000, according to estimates by the U.S. Centers for Disease Control and Prevention in Atlanta. That costs the federal government more than $10 billion annually, according to a 2009 report from the U.S. Chamber of Commerce.
Worldwide, flu causes between 250,000 and 500,000 fatalities every year, according to the Geneva-based World Health Organization. In China this year, a new type of bird flu known as H7N9 has sickened at least 131 people and killed 36 of them, according to the WHO.
Sanofi’s Fluzone shot was used in the study, as well as vaccine boosters made by Sigma-Aldrich Corp. (SIAL) and Novartis. The experimental vaccine, whose intellectual property belongs to the NIH, may be up for grabs.
“It needs to get into people,” Nabel said. It’s up to the NIH to decide “to which party or parties they want to license it. I don’t think the final disposition has been settled.”
With Sanofi, there “could be nice synergies” for the product’s development, Nabel said, adding that as a former NIH employee he wouldn’t be able to himself negotiate an agreement between Sanofi and the NIH. “Obviously I will help whoever wants to advance this forward to humans,” he said.
The synthetic nanoparticle vaccine, which was tested on mice and ferrets, works by stimulating the production of neutralizing antibodies that latch on to parts of the virus that are common to different strains. Given that it’s made entirely from recombinant ingredients, it’s safer to make than standard vaccines, which are produced by growing the virus in eggs or cultured cells, according to a Nature press release.
“This is a very encouraging study of a new approach to making vaccines and shows very clearly this works very well with ferrets against different strains of flu,” Adam Finn, a professor of pediatrics at the University of Bristol Medical School in England, said in a separate statement. “Further studies will be needed to find out whether humans get similar protection and these are likely to take several years.”
Vaccines such as Fluzone are usually created each year from inactivated viruses of three different strains. They work best against those strains and need to be replaced after a year. A universal vaccine could provide protection against most or all flu strains for decades.
“The goal for all influenza vaccine researchers right now is to develop that universal vaccine,” Nabel said. “Without a question, that’s one of the most urgent public health needs.”
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