Staff Writer
Related story: Spanish flu link could explain H1N1's spread
The emergence of the novel influenza A H1N1 virus provided evidence of something public health leaders had long worried about -- that traditional flu vaccine manufacturing would need months to respond to a new virus.
Special
Dr. Sang-Moo Kang, a team leader in Dr. Richard Compans' lab, purifies and concentrates viruslike particles.
Special
Dr. Sang-Moo Kang, a team leader in Dr. Richard Compans' lab, purifies and concentrates viruslike particles.
Special
Dr. Sang-Moo Kang, a team leader in Dr. Richard Compans' lab, purifies and concentrates viruslike particles.
While the first novel H1N1 vaccine shots are expected to roll out in October, researchers in Georgia are looking at new methods for vaccine production that could potentially create a vaccine much quicker that could also be more accurate, cover more flu strains and potentially be safer.
One approach is called a viruslike particle -- VLP -- vaccine. A virus called a baculovirus is re-engineered to express the hemagglutinin, HA, protein and other proteins from the target flu strain. The baculovirus infects insect cell lines in the lab, which then express out the virus proteins in a new particle that the host's immune system recognizes as a virus and creates antibodies against. It is safer because it does not use a virus genome to infect host cells.
In work done by Emory University's Richard Compans with VLP vaccine created with material from the avian influenza H5N1 virus, the vaccine created a powerful response in mice with a fraction of the material normally needed to get a response.
A normal seasonal influenza shot would contain about 15 micrograms of antigen to produce the protective antibodies, said Dr. Compans, director of the Influenza Pathogenesis and Immunology Research Center, a joint center of excellence of Emory and the University of Georgia.
"In animal studies, we're seeing that very low doses, as low as 2 micrograms, was sufficient to completely protect against a high infectious dose," he said. VLP vaccines would have a number of advantages over the traditional method of influenza vaccine, which relies on injecting the strain into fertilized eggs and growing the vaccine virus strain inside them.
"Use of chicken eggs is kind of an old-fashioned and time-consuming procedure," Dr. Compans said, taking months to produce a vaccine. VLP vaccines are able to turn around vaccine much quicker -- Dr. Compans' lab has already produced a VLP vaccine against the novel H1N1 virus and it seems to be effective in mice, he said.
Ralph Tripp, of UGA and associate director of the joint influenza center of excellence, said his lab is testing a VLP vaccine, created by Novavax, in pigs with the new virus.
"You could cut out several months, get it down to at least on the order of as little as two months," Dr. Compans said. That would allow vaccine to be made closer to the traditional beginning of the flu season instead of selecting the vaccine strains in February, as is done with traditional egg-based manufacturing. That could potentially allow for a more accurate vaccine to the specific flu strains in circulation.
The VLP process would also eliminate the need to handle potentially deadly pandemic flu strains during manufacturing. Dr. Compans' work in avian influenza revealed another potential advantage -- the effect appears to last.
"We've seen responses as long as we've measured," he said. "I think the studies have gone out to 20 months in mice, which is almost as long as a mouse will live, and they're still protected."
And when the vaccine includes an adjuvant protein that appears to boost its effect, it appears to cover a broader spectrum of influenza strains in mice, Dr. Compans said.
"There are at least two main advantages this would offer. It would potentially lessen the need to have annual vaccinations," he said. The other is it might provide some protection should a new strain emerge, as happened this year, he said.
Another new vaccine approach is using mammalian cells created in the lab to grow a vaccine strain, as Dr. Tripp is doing at UGA. This process is also much quicker than the egg-based approach -- reducing production time by three or four months -- and more flexible than current approaches, he said.
The cell-based approach eliminates egg proteins from the vaccine (a problem for those with egg allergies) and also the possibility of other viruses lurking in the eggs, Dr. Tripp said. Novel H1N1 virus doesn't appear to grow very easily in eggs and other potential pandemic viruses are an even bigger problem, he said.
"Most of the (highly pathogenic) avian influenza viruses actually kill eggs when they infect them," Dr. Tripp said. "So it is very hard to make a vaccine for high-path H5N1 for example."
Dr. Compans and colleagues at Georgia Tech have been working on another approach that would make getting flu vaccine easier -- a microneedle array technique that could apply vaccine to the skin without using needles and syringes. It uses tiny needles coated with vaccine to apply it directly through the skin.
"It has many advantages: it's painless. A lot of people don't like to get vaccinated because they don't want to be stuck by a needle," he said. "It potentially works with lower vaccine doses; and it doesn't produce the hazardous waste of leftover needles and syringes."
It could potentially be made as a patch that people could apply themselves, eliminating the need to line up for clinics in the event of a pandemic, Dr. Compans said. A better vaccine and a better way to give it is possible in the future.
"We are pursuing both lines of work," Dr. Compans said.
Reach Tom Corwin at (706) 823-3213 or tom.corwin@augustachronicle.com.
Click here to see a graphic explaining the new vaccine.
FLU CLINICS
Available this week at county health departments unless otherwise noted:
BURKE: Monday, 8 a.m. to 7 p.m.; Tuesday-Thursday, 8 a.m. to 5:30 p.m.; Friday, 8 a.m. to 4:30 p.m.
COLUMBIA-EVANS: Monday, 8 a.m. to 7 p.m.; Tuesday, 8 a.m. to 4 p.m.
COLUMBIA-GROVETOWN: Monday, 8 a.m. to 7 p.m.; Tuesday, 8 a.m. to 4 p.m.
COLUMBIA-APPLING: Monday, 8 a.m. to 7 p.m.; Tuesday, 8 a.m. to 4 p.m.
EVANS LIBRARY: Wednesday,1-4:30 p.m.; Thursday, 10 a.m. to 4:30 p.m.
EMANUEL-SWAINSBORO: Monday, 8 a.m. to 7 p.m.; Tuesday, 8 a.m. to 6:30 p.m.; Wednesday-Thursday, 8 a.m. to 4:30 p.m.; Friday, 8 a.m. to 4:40 p.m.
EMANUEL-ADRIAN: Wednesday, 8:30 a.m. to 4 p.m.
EMANUEL-TWIN CITY: Monday, 8 a.m. to 4:30 p.m.; Tuesday, 8 a.m. to 6:30 p.m.; Wednesday-Thursday, 8 a.m. to 4:30 p.m.; Friday, 8 a.m. to 2 p.m.
GLASCOCK: Monday, 8 a.m. to 5 p.m.; Tuesday, 8 a.m. to 6:30 p.m.; Wednesday to Friday, 8 a.m. to 5 p.m.
JEFFERSON: Monday, 8 a.m. to 6:30 p.m.; Tuesday-Friday, 8 a.m. to 4:30 p.m.
JENKINS: Monday, 8 a.m. to 7 p.m.; Tuesday-Friday, 8 a.m. to 5 p.m.
LINCOLN: Monday-Friday, 8 a.m. to 4:30 p.m.; closed daily noon to 12:30 p.m.
McDUFFIE: Monday, 7 a.m. to 5 p.m.; Tuesday, 7 a.m. to 7 p.m.; Wednesday, 7 a.m. to 6 p.m.; Thursday, 7 a.m. to 7 p.m.; Friday, 7 a.m. to 5 p.m.
RICHMOND-SOUTH AUGUSTA: Monday, 8 a.m. to 7 p.m.; Tuesday-Friday, 8 a.m. to 5 p.m.
RICHMOND-LANEY-WALKER: Monday, 8 a.m. to 7 p.m.; Tuesday-Friday, 8 a.m. to 5 p.m.
SCREVEN: Monday, 8 a.m. to 7 p.m.; Tuesday-Friday, 8 a.m. to 4:30 p.m.
TALIAFERRO: Monday, 8 a.m. to 5 p.m.; Tuesday-Friday, 8 a.m. to 5 p.m.
WARREN: Monday, 8 a.m. to 7 p.m.; Tuesday-Friday, 8 a.m. to 4:30 p.m.
WILKES: Monday, 8 a.m. to 7 p.m., Tuesday-Friday, 8 a.m. to 4:30 p.m.
Q & A
Q: When will a vaccine against novel influenza A H1N1 become available?
A: The only certain shipment for early October is 3.4 million doses of the live inactivated nasal mist vaccine, which will be distributed on a population basis, said Dr. Jay Butler, chief of the 2009 H1N1 vaccine task force for the Centers for Disease Control and Prevention.
For the rest of the novel H1N1 vaccine, the CDC has contracted with McKesson Corp. to ship the vaccine and Georgia has one of the four distribution sites, according to the Georgia Department of Community Health. The state would not say where it is for security reasons. The state had hoped the distribution would begin sometime in late September or early October when the initial 45.2 million doses were released. Another 18.6 million was expected will go out by Oct. 31.
Georgia was expected to get 2 million of those doses by the end of October, Georgia DCH said. McKesson is going to ship directly to larger providers, those providing 100 shots or more, who have signed a provider agreement. Small providers will get their doses through the county health department. Those who would like to be providers can sign up with their health district office. They have to agree to give the novel H1N1 vaccine to those in the priority group, which includes pregnant women, those who live with an infant less than 6 months of age, children and young adults ages 6 months to 24 years old, direct care patient providers and adults with underlying health conditions that put them at risk for complications from flu.
Q: Why are there two flu shots this year?
A: One is against the seasonal flu strains that circulate during a typical flu season. After the novel influenza A H1N1 was identified in April, the decision was made not to hold up production of the seasonal shot to include it in that shot but to produce a vaccine against that strain separately. Production of the novel H1N1 shot began after production of the seasonal vaccine was completed.
Q: Will the seasonal flu shot help protect against novel H1N1 infection?
A: It is not expected to help provide much protection, particularly in young people.
Q: So why get the seasonal flu shot?
A: While the novel H1N1 is the dominant flu strain now and became the dominant flu strain during flu season in the Southern Hemisphere, which precedes flu season in the U.S., how influenza will play out here is unpredictable. The seasonal strains could make a resurgence and could still cause problems for vulnerable populations. The CDC recommends seasonal influenza shots for those at risk of complications.
Q: Is the novel H1N1 vaccine safe?
A: The FDA thinks so. Last week, the agency approved all of the novel H1N1 vaccines even though they are still in clinical testing. The agency said it did so because the vaccine was produced using the same process as the seasonal flu vaccine, which FDA said has a history of safety and effectiveness.
Q: What are the side effects?
A: According to information from the manufacturers, side effects are mild and include rash, influenza-like symptoms and reactions at the site of the injection.
Q: When can I get the shots?
A: The seasonal influenza vaccine is available now, although some providers with Vaccine for Children who treat Medicaid patients are still waiting for their shots. Counties in the East Central Health District around Augusta will begin holding their flu clinics on Monday and run through Friday .
STRAIN CHANGED SINCE SHOT'S FORMULATION
Though there is no evidence it will provide any protection against novel influenza A H1N1, public health officials are making a strong push for people to get the seasonal flu shot, particularly the elderly. That shot contains two influenza A and one influenza B strains.
However, there might be a problem with one of the influenza A strains, known as H3N2. Since the flu strains for the vaccine were selected back in February, the circulating H3N2 strain has changed, according to Ralph A. Tripp, associate director of the Influenza Pathogenesis and Immunology Research Center at the University of Georgia and Emory University, one of six regional centers of excellence in influenza funded by the National Institutes of Health. The phenomenon is called antigenic drift -- the composition of the antigens by which antibodies in the immune system would recognize the circulating virus has changed enough that it might go unrecognized. That means the level of protection from the seasonal flu shot against that particular strain has been reduced, Dr. Tripp said. For example, it might have gone from 80 percent to 60 percent, but the exact level of reduction is not known yet, he said.
The Centers for Disease Control and Prevention is "aware of the drift strain of H3N2 but we are not seeing widespread circulation at this point," spokesman Tom Skinner wrote in an e-mail. "It's early in our flu season and flu is unpredictable. We encourage people to get vaccinated, particularly if they are in a priority group for vaccination. It's possible that circulation of the seasonal flu viruses included in the vaccine may increase and people need to be prepared."
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