Swine Flu Vaccine Testing: What You Need to Know
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There’s good news on the swine flu front, and it comes from Argentina, of all places. After appearing in North America in April and reaching pandemic level – a first for the flu in the more than 40 years - scientists and researchers are following the disease in Argentina and other locations in the southern hemisphere to check for any foreboding mutations.
So far, so good, says Francisco Alvarado-Ramy, supervisory medical officer with the Centers for Disease Control. “We are monitoring what is happening in the southern hemisphere – Argentina, Chile and New Zealand – and so far the information we have is that the virus is behaving similar to what we saw in the spring,” Alvarado-Ramy said.
So for now, the expectation is for the disease to remain in its generally non-lethal form, duplicating the experience for most Americans in April and May. “Except that in the fall and winter we can expect more cases, but with the severity behaving much the same way as it has been,” Alvarado-Ramy said.
Dr. David Kimberlin, a Birmingham, Ala., pediatrician and member of the Committee on Infectious Diseases of the American Academy of Pediatrics, agreed. “We know what is circulating in the southern hemisphere and we are not seeing the mutations that would suggest a lethal twist in this virus,” he said.
Even better news, said Kimberlin, is a comparison of the novel H1N1 virus and the worst flu pandemic in the history of the country. In 1918, a pandemic of Spanish flu was responsible for an estimated 50 million deaths. That flu, Kimberlin said, was relatively mild the first year and then mutated between the first and second season to become a killer.
Scientists know what made up the Spanish flu, “and those genes are not in the H1N1 strain going on right now,” Kimberlin.
So far, scientists and researchers have completed at least two-thirds of the work necessary to come up with a vaccine that can be safely administered throughout the country, according to an update on August 7 on the Worth Health Organization’s web site.
Once a new strain of influenza with pandemic potential has been identified, it takes an estimated 5 months for the first supplies of approved vaccine to become available. Here is a vaccine timeline, including steps already taken and those that remain, according to the WHO.
- Identify the new virus. Samples of a virus strain different from existing strains are collected and studied in labs around the world.
- Prepare the vaccine strain. This laboratory work is required for the virus to be used in the manufacturing process of a new vaccine.
- Manufacturing the vaccine. This occurs after the vaccine virus arrives from the WHO scientists and is first tested to determine optimum growth conditions.
- Clinical Studies. This is actually occurring now in five countries – China, Australia, the United Kingdom, Germany and the United States, according to the WHO. Officials have estimated the initial results of the trials should be available in September.
- Regulatory approval. This is required before the vaccine can be sold and different agencies handle the process around the world. Because the vaccine is made in a similar fashion to the seasonal flu, this often takes very little time.
The process is moving smoothly so far, said Alvarado-Ramy. The vaccine will be distributed nationally by about five pharmaceutical companies, with the goal of blanketing the country with the vaccine as soon as possible, according to the WHO. In fact, when all the companies are working at full strength, the weekly production could hit 94 million doses of swine flu vaccine.
It’s a process that is entirely comforting to Amy Garcia, R.N., and executive director of the National Association of School Nurses. “I think parents have a right to be concerned” about the testing and development of a vaccine, Garcia said. “But I’ll you that I’ll be in line for the vaccine and my kids will be in line,” she said. “I have seen these vaccine-type diseases (such as whooping cough). Anything that can be prevented should be prevented. The American public has forgotten how deadly some diseases can be. We (the school nurses association) believe in vaccines.”