Swine Flu Shot in U.S. May Rely on Emergency Use of Additives
July 29 (Bloomberg) — Swine flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic.
The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials, meeting today at the U.S. Centers for Disease Control and Prevention in Atlanta, plan to discuss use of the additives, and may also recommend who should be first to receive the limited amount of vaccines drugmakers say they will begin delivering in October.
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CSL Ltd., which has a $180 million order to supply bulk H1N1 antigen to the U.S. government, decided against boosting its vaccine with an adjuvant, preferring to use a formulation more closely resembling the seasonal flu shot, said Mary Sontrop general manager of the Melbourne-based company’s biotherapies unit.
The U.S. has contracts with five companies to provide flu shots. Novartis, based in Basel, Switzerland, is responsible for 45 percent of the supply, while Sanofi will provide 26 percent and CSL will make 19 percent, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, in an interview last week.
The remaining doses will be made by Glaxo and London-based drugmaker AstraZeneca Plc.
“Cabin Fever
Trying to stop the spread of swine flu at summer camp.
By Marc Siegel, Posted Friday, July 10, 2009,”
http://www.slate.com/id/2222549/
“For three summers, my 12-year-old son, Joshua, has attended Camp Modin, a beautiful camp in rural Maine. This year, when we dropped him off at the northbound bus, something was different: The counselors were taking children’s temperatures before letting them onboard. It seemed a wise precaution, as the new influenza A H1N1 swine flu strain continues to spread and the weather in Maine in June was cool this year, which would facilitate an outbreak of the virus. But as a physician who has studied the flu for many years, I was still worried. An infected person can be contagious even if he doesn’t have a fever.
My concern was justified. Three days after camp started, I called the camp director, Howard Salzburg, and discovered that he was beside himself. One of the parents, another physician, had used Tylenol to deliberately suppress his child’s fever so he wouldn’t be held back.
There were already 16 cases of the flu, confirmed by the Maine Center for Disease Control and Prevention to be the H1N1 swine flu strain.
Desperate to contain the infection, Howard had created a quarantine bunk for the sick and was having all the bunks cleaned with hospital-grade disinfectant.
One other tool could help stem the spread of infection—but using it would go against CDC protocol”...
...”it seemed to me it was time for our public health authorities to employ a more aggressive strategy.
Clinical trials have shown that Tamiflu, when taken within 48 hours of exposure, is 92 percent effective at preventing flu in adults and 82 percent effective in children.
Since we don’t yet have a vaccine, it was clear that the best strategy was to use the drug, which decreases the severity and the duration of the illness and helps prevent people who are in contact with flu patients from getting sick themselves.
I e-mailed the camp parents to let them know that Tamiflu is well-tolerated and safe and that I was starting my son on a 10-day course of it; it would be wise, I recommended, for them to do the same.
Prescriptions were soon flooding the camp’s fax machine; out of the 350 campers, 250 campers were started on the drug, as were more than 100 staffers.
At the same time that the prescriptions were pouring in, the Maine CDC asked to speak to me, since this was not its usual protocol.
It was holding Tamiflu in reserve for the sickest cases.
But our children had no immunity to this new strain of flu. Though most of the stricken Modin campers were only mildly ill, we’ve seen that the majority of the severe cases and deaths caused by this strain are occurring among children with chronic illnesses like asthma. Since campers could have had those conditions but not yet have been diagnosed, it made a lot of sense to use Tamiflu to reduce the amount of circulating virus.
I also explained to the director that most of the studies using anti-virals as a preventative, conducted in nursing homes, were likely applicable to the camp environment, since kids were crammed in bunks just as patients in nursing homes live close together.
Andrew Pelletier, the head epidemiologist for the Maine division of the CDC, said that his caution was informed by federal directives.
The Tamiflu protocol was based in part on fear of a shortage.
Supplies in Maine were plentiful—the camp had been able to procure more than 400 courses of Tamiflu with ease.
But the CDC was reluctant to dip too far into the supply, worried that not enough would be available if and when the new flu becomes more widespread.
Runs on Tamiflu and premature use of the drug, as people attempt to hoard it in case they or their families became sick, were another cause for concern.
I’m sure you are also concerned about resistance developing from overuse of the drug, I told him, but with a vaccine not yet ready, using Tamiflu to control outbreaks at camps is exactly what we should be doing.
The CDC allowed Modin to proceed,” (would the CDC have forbidden doctors to give Tamiflu to their patients?) “and the results were even more dramatic than I’d anticipated.”...
...”Camp Modin was perhaps the first experiment in close quarters with Tamiflu against the new pandemic strain.
When the camp started using it, the total number of cases was 40, and the daily incidence was 14.
Two days later, the number of new cases was four.
(Look at the Modin statistics here.)
http://www.slate.com/id/2222549/sidebar/2222551/
“16 new cases of the influenza H1N1 swine flu strain, June 24-29
24 new cases on June 30
Tamiflu treatment and prophylaxis started on July 1 and 2
14 new cases on July 1
15 new cases on July 2
4 new cases on July 3
3 new cases on July 4
1 new case on July 5
1 new case on July 6
0 new cases on July 7
Overall, 6,000 screening temperatures were taken.
Five children stopped Tamiflu due to nausea.
Children were screened by the camp doctor, Dr. Marvin Lee, for ear, sinus, and throat infections that often accompany the flu, and antibiotics were prescribed for four children”
“There were soon more than 80 campers and staff with the flu—all cases were mild, and the first three were confirmed as H1N1 swine flu strain by the CDC—but no one on Tamiflu as a preventive measure became sick, not even the counselors and nurses who were caring for the quarantined bunk.
While my son took his daily Tamiflu dose and enjoyed the wilds of Maine, the quarantined kids watched TV and played video games for a week before being allowed to return to their regular bunks. “...
..”As cases of flu began to appear at other camps in Maine, word of Modin’s successful containment spread, and pediatricians were again asked to fax prescriptions to Maine for Tamifu.
It is clear that especially in advance of a vaccine, Tamiflu is an effective way to squash H1N1 outbreaks and protect the most vulnerable.
If we use it properly now, we may not need it as much in the future.
It is definitely time for the CDC to change its protocol. “
Posted on Sat, Aug. 01, 2009
JASON EBERHART-PHILLIPS: PREPARE FOR MORE H1N1 VIRUS THIS FALL
As the H1N1 flu epidemic enters its fourth month in Kansas, the lurid headlines and cable news frenzy that marked the early stages of the outbreak are over. It may seem that the threat is gone. But the virus never left.
Here and around the world, the H1N1 pandemic is gaining momentum. We need to get ourselves prepared.
For a completely new organism, the novel H1N1 flu virus has a remarkable capacity to transmit itself among human hosts. In only 100 days, it spread from two countries on one continent to 160 countries on every continent of the world.
Most disease has been mild, or without any noteworthy symptoms. But for a significant minority of hosts, the disease has been severe. Already the pandemic strain has claimed about 800 lives worldwide, three times the number lost to the “bird flu” since 2003.
The Centers for Disease Control and Prevention estimates that in the next two years, 20 to 40 percent of the U.S. population will be stricken, with many of the cases compressed into “waves” of infection lasting eight to 12 weeks. The number of pandemic-related deaths could range from 90,000 to several hundred thousand.
In Kansas, as many as 10,000 cases already have occurred, with confirmed disease now reported in 35 counties throughout the state. Ordinarily flu is not seen during summer months, but more counties were newly confirmed with H1N1 disease during July than in any previous month.
The pattern of cases here, as in other states, points to a distinctly higher risk for the young. The average age for confirmed cases in Kansas is just 17 years, with about 80 percent of cases occurring before the age of 35 years. Although the elderly would comprise a majority of severe cases in a normal flu season, cases of H1N1 flu are relatively rare in people over 65.
Our objectives are to reduce illness and death from the pandemic while minimizing social disruption. Together we will monitor the spread of the disease, advise health care providers on treatment and prevention, educate the public on “social distancing” and other techniques to slow down transmission, and, if necessary, release publicly held stockpiles of antiviral drugs that can speed recovery in cases of severe disease and reduce the risk of fatal complications.
At the same time this fall, we will work with local public health departments to administer the largest single vaccination campaign our state has ever seen, if federal health authorities decide to make an H1N1 vaccine available for use in the whole population.
Hospitals and other health care providers are now making sure they are ready for a surge in demand for their services in the months ahead. Businesses around the state are preparing for continuity of operations in the event of high levels of absenteeism. Schools are preparing teachers and parents for heightened vigilance, strict exclusion of ill students, and possible schoolwide dismissals.
If you have gotten out of the habit of careful handwashing, covering your coughs and staying in when you’re ill, it’s time to take such precautions again. For information on H1N1 flu activity, go to the Web site www.kdheks.gov.
In a pandemic, neither alarm nor complacency is helpful. But by understanding the risks, taking reasonable steps to prevent transmission, and working together on solutions, we will get through this and keep one another safe.
Jason Eberhart-Phillips is Kansas state health officer.
http://www.kansas.com/950/story/913603.html