PROVIDENCE – An analysis of the new strain of what’s being called Shanghai bird flu, known as H7N9, conducted by Dr. Anne S. De Groot and her team of researchers at EpiVax Inc., has concluded that there may be a need to develop a new vaccine to combat a potential devastating outbreak of the disease.
In addition, De Groot and her EpiVax team have developed recipes for both DNA-based and protein-expression vaccines that they are willing to share with global and federal health authorities. The company’s work is focused on the viral coat and the internal proteins of the H7N9 virus.
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There are two distinct sources of worry about the new strain, according to De Groot, who is chief science officer, founder and CEO of EpiVax, a Knowledge District-based biosciences firm that has pioneered the technology of immunoinformatics to design and manufacture vaccines.
The first is the likelihood that the new flu outbreak may be related to a massive pig die-off in March in China, suggesting that the flu already may have migrated from a mammalian host.
“Everyone is calling H7N9 a bird flu, because this particular strain was found in poultry market and pigeons,” she said. Despite the reports by Chinese authorities that it doesn’t seem to be spreading from humans to humans, De Groot expressed worry that the flu outbreak could be linked to serious pig die-offs in China, with a mammalian signature. “When you hear of a massive pig die-off, with pig carcasses flowing down the river to Shanghai, overflowing from the pig cemeteries upstream, it suggests something very virulent, such as pig influenza outbreak,” she said.
De Groot cited a story by Laurie Garrett of The Denver Post, who reported on April 7 that 16,000 pig carcasses had reached Shanghai by March 20 along the Huangpu River, a tributary of the Yangtze River. Hundreds of miles west of Shanghai, pig carcasses also washed up along the shores of Xiang River in Changsha – along with thousands of dead ducks.
“One very plausible explanation is that the H7N9 virus has undergone a mutation — perhaps among spring migrating birds,” Garrett wrote. “Once influenza adapts to pig cells, it is often possible for the virus to take human-transmissible form. That’s precisely what happened in 2009 with the H1N1 swine flu, which spread around the world in a massive, but thankfully not terribly virulent, pandemic.”
The second major concern voiced by De Groot about the need to move quickly to develop a flu vaccine is that Epivax’s analysis showed that cross-protection from previous flu vaccines used during the last few years may not stimulate defenses against the new strain.
“In 2009, we predicted that there would not be as many hospitalizations as feared by the Centers for Disease Control and Prevention for H1N1,” she said. “This flu strain is much more worrisome, because the same type of cross-protections are not there for this flu. People will not have the antibodies because of the different viral coat, and we also predict that they won’t have the cross-protective T-cell responses,” De Groot said, based on her team’s analysis.
Unlike the traditional antibody vaccines that are grown in eggs and then harvested, EpiVax’s vaccines recipes could immediately go into production in a much more efficient manner, according to De Groot.
“The process of manufacturing flu vaccine with eggs is so inefficient,” De Groot said. “The last time [we had a pandemic], it took twice as long as expected – six months instead of three – to get enough vaccine for people, but by that time the [H1N1] flu pandemic had already peaked. Ever since, the U.S. government has been investing in alternative approaches. DNA vaccines are one of the alternatives. They are safe, effective, and we know how to deliver these vaccines.”
De Groot said that she had been in contact with researchers at Shanghai’s Pasteur Institute, the National Institutes of Health as well as with the U.S. Defense Department, which EpiVax is currently working with to develop vaccine on demand for Lassa fever.
The director of the Centers for Disease Control and Prevention has sought to reassure the American public, according to a Reuters story published on April 7. “We work to have the public’s back,” said Thomas Frieden, director of the CDC. “It’s our job to be concerned and to move quickly whenever there’s a potential problem.”
But De Groot also voiced concern about the CDC’s approach. “They don’t have a vaccine for this new strain,” she said. “If they start to make a new vaccine, it will be using the standard approach, the egg approach.”
EpiVax’s focus, De Groot continued, “is on T-cells. The CDC focus is on antibodies. They don’t get the importance of cross-protective T-cell response.
In terms of moving the EpiVax recipe for the flu vaccine into production, De Groot said it could be done in a few days, either working with a factory in North Dakota for the DNA-recipe or at a new protein-expression facility in Texas run by the Defense Department, where it would be possible to produce millions of doses in a week.
In answer to a question about the proprietary nature of the recipes, De Groot said that it wasn’t her immediate concern. “It does not need to stand in the way of getting a H7N9 vaccine up and running. There is no time to waste.”
