| | |  Health & Beauty | October 2009 
Swine Flu Shot Gets Mexican Test
 Matthew Herper - Forbes.com
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October 21, 2009
 |  | A vaccine for the 2009 H1N1 influenza virus made in insect cells could be approved in Mexico as early as next year. |  | | |
If the 2009 H1N1 influenza strain had turned out to be a killer, we'd have been in trouble, because right now drug companies can't produce enough flu shots to go around.
Novavax, a tiny biotechnology firm, is turning the shortage into an opportunity. It says it will soon start clinical trials of its experimental vaccine for the 2009 H1N1 influenza in Mexico.
Any other year, Novavax's effort would have seemed like a long shot. Its vaccine is genetically engineered and produced in insect cells - pretty different from producing shots in chicken eggs, as most vaccine makers now do. Regulators might have wanted more proof that the method could work. But Mexican authorities are letting Novavax go ahead with a trial against the new H1N1 strain in 3,000 people with the aim of selling the shots in Mexico in 2010.
The 2009 H1N1 flu - sometimes called swine flu because it resembles viruses found in pigs - is forcing a global rethinking of flu shots. The decades old process of making shots in chicken eggs just isn't up to battling a pandemic. Eggs from hundreds of thousands of chickens are infected with flu virus - roughly one egg for every dose made - and then purified to make the killed-virus vaccine. It takes four or five months to develop a new vaccine.
The United States Centers for Disease Control had forecast that there would be as many as 120 doses of vaccine available in October. Instead, less than 30 million are expected, meaning only those who need vaccines most, like kids and pregnant women, are likely to get them.
"That's the situation in the most powerful country in the world. What do you think is going on elsewhere?" says Rahul Singhvi, Novavax's chief executive and former head of vaccine manufacturing at Merck ( MRK - news - people ). His company's vaccine is not as different from previous entrants as it might seem, he says. And because Mexico needs to look for new sources of H1N1 inoculations, it must make the tough decision of whether it's better to try out a new approach - or not have any vaccinations at all.
For Novavax, Mexico represented a perfect proving ground for its technology. The 2009 H1N1 pandemic started there, and the virus is still spreading fast. That means that lots of people in the study are likely to be exposed to it, and it will be possible to see if the 2,000 participants who receive Novavax's shots get confirmed infections less than the 1,000 who don't. If their immune systems respond and the vaccine appears safe, Mexican regulators would be likely to approve it, Singhvi says.
Novavax is conducting the study with Avimex, a Mexican vaccine maker, and General Electric's GE Healthcare unit, which is manufacturing the vaccine.
Vaccinations against 2009 H1N1 should actually be more effective than those against seasonal flu. Flu shots are thought to be 80% effective at preventing infection against the virus contained within them, but health officials have to guess which strains of flu are circulating. Sometimes they're wrong, and that makes the flu shot less effective.
Novavax's vaccines utilize what are called virus-like particles - genetically engineered molecules designed to train the immune system to recognize a particular virus. Singhvi points out that vaccines for the human papilloma virus (HPV) are also made using virus-like particles, and that a newly approved HPV vaccine, Cervarix from GlaxoSmithKline, makes these particles in the same type of insect cells his company uses.
Other high tech approaches are in the works. VaxInnate, of Cranbury, N.J., is working on making a new type of vaccine in bacteria. The technology is very different from any marketed vaccine, but it could produce large volumes of inoculation quickly and cheaply. Vical, of San Diego, Calif., is working on flu vaccines that work by delivering DNA into cells. |
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