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Health Officials Race to Create H1N1 Flu Vaccine

May 20, 2009 at 12:00 AM EDT
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At the World Health Organization's annual meeting this week, a main topic was the ongoing effort to develop a vaccine against the H1N1 swine flu virus. Betty Ann Bowser reports on efforts to create a new vaccine and concerns over having the time to properly produce it.

JIM LEHRER: And next, creating a new flu vaccine. Betty Ann Bowser reports for our Health Unit, a partnership with the Robert Wood Johnson Foundation.

BETTY ANN BOWSER, correspondent: Ever since swine flu started sweeping the globe in near pandemic proportions, health officials have been worried about creating a vaccine to fight it. It’s so much of a concern that it’s overshadowed all other topics on the agenda at the World Health Organization’s annual meeting in Geneva this week.

Dr. Margaret Chan is the director-general of the World Health Organization, or WHO.

DR. MARGARET CHAN, director-general, World Health Organization: In the name of global solidarity, I have reached out to drug companies and vaccine companies and start discussion with them. I would like to thank them for their cooperation.

We will look at different mechanisms to ensure that poor countries are not left behind without access to both medicines, antivirals, as well as a pandemic vaccine, should that be required.

BETTY ANN BOWSER: So far, the virus has infected some 10,000 people in over 40 countries and killed more than 80.

And this time, U.S. health officials say they don’t want to repeat any of the mistakes that were made back in 1976, when the U.S. government implemented a nationwide vaccination program against swine flu.

Dr. Anthony Fauci is the director of the National Institute of Allergy and Infectious Diseases.

DR. ANTHONY FAUCI, director, National Institute of Allergy and Infectious Diseases: The decision back in 1976 to both produce the vaccine against the 1976 swine flu and distribute it to as many Americans as you could was actually coupled in the same decision. So once the decision was made to make it, then they were going to give it.

BETTY ANN BOWSER: Back then, after a young recruit at Ft. Dix, N.J., died from the disease, several hundred others on the base got sick.

SCIENTIST: For the first time in the history of the world, we have a vaccine ready in plenty of time to protect everyone against this infection.

Lessons from the past

BETTY ANN BOWSER: Forty-five million people were inoculated, but the government abandoned its vaccination effort after 10 weeks. That was because about 500 people developed rare side effects of an autoimmune disease called Guillain-Barre syndrome. It can lead to paralysis, and about 25 deaths were associated with the vaccination.

DR. ANTHONY FAUCI: The lesson is to make sure that you have separate decisions about production, how much to produce, and then whether to administer or not. And you should give yourself the opportunity at multiple points in that process to say, yes, we have enough evidence to go ahead or, no, we don't. That's the major lesson to be learned.

BETTY ANN BOWSER: Beyond those questions, the government and vaccination manufacturers are wrestling with a more fundamental issue. Dr. Bruce Gellin heads the U.S. National Vaccine Program.

DR. BRUCE GELLIN, director, National Vaccine Program Office: The biggest challenge, frankly, is time. This is a virus that emerged relatively recently, and the goal would be to have a vaccine available, should there be a need to use it, in the fall.

BETTY ANN BOWSER: Here, at Sanofi Pasteur in Swiftwater, Pa., the world's largest manufacturer of influenza vaccine, the company's labs are now waiting for the arrival of an H1N1 seed strain from the Centers for Disease Control in Atlanta.

It's one of seven labs around the world racing to find the key ingredient: the seed strain, which is an actual sample of a virus, that is used to develop a vaccine.

PHIL HOSBACH, vice president, Sanofi Pasteur: We're prepared. We're ready to go. We're still waiting for that seed virus. And once someone tells us what our role and responsibility is, we can begin the manufacturing process, shortly after receiving that seed virus.

Flu season in Southern Hemisphere

BETTY ANN BOWSER: Phil Hosbach is vice president of Sanofi Pasteur. He's in charge of the company's response to the potential pandemic.

PHIL HOSBACH: What we would do is we would take that working seed and introduce it into our full-scale manufacturing process. And that would normally take about three to four months before it would yield the first doses that we could make available to public health authorities.

BETTY ANN BOWSER: While newer manufacturing technologies have emerged, most flu vaccine production, like Sanofi Pasteur's, relies on a 50-year-old process that depends on chicken eggs. And according to flu experts, it's proving to be the most reliable method for developing an H1N1 vaccine.

PHIL HOSBACH: We're inoculating eggs with these -- with this seed virus, the working seed virus. The virus itself grows inside the eggs, and it multiples. We then harvest the material from inside the eggs, and we filter out, and we have just the virus remaining.

BETTY ANN BOWSER: About two to three weeks after that, the resulting growth is taken from the eggs and used to develop small pilot lots of vaccine for clinical trials coordinated by the National Institutes of Health.

Right now, all eyes are on the southern hemisphere, where the fall and winter flu season is just getting underway. And the swine flu virus, like all influenza viruses, can mutate as it moves around, another potential problem for vaccine production.

DR. BRUCE GELLIN: Influenza viruses are evolving all the time. From the perspective of a vaccine, what's important is to try to determine whether or not they've evolved so much that a vaccine you create today is no longer as -- might no longer be as effective to a virus that returns in the fall.

Looking at the genetics of the virus and looking at some of the patterns that happen over the summer will give us some indication of whether or not a vaccine that we're developing now would be effective in the fall.

Questions remain

BETTY ANN BOWSER: Health officials, here and abroad, told the NewsHour today they think vaccine manufacturers are on track to create a vaccine by fall, but many questions remain about how many doses can be produced and who should get the vaccine.

U.S. Health and Human Services Secretary Kathleen Sebelius spoke to reporters while attending the WHO meeting in Geneva yesterday.

KATHLEEN SEBELIUS, Health and Human Services secretary: The discussion moving forward has to involve how that capacity, if and when a vaccine is necessary, is distributed and what is the appropriate not only protocol for who gets vaccinated, who is the most vulnerable population, in what order, but how then we deal in the developed countries with developing countries.

BETTY ANN BOWSER: Both U.S. and World Health Organization officials say the seed strain should be in the hands of manufacturers by the end of the month.

And they don't anticipate having drug-makers interfere with their production of current seasonal flu vaccine.