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A Dose of Swine Flu (H1N1) Vaccine Works for Pregnant Women,Two for kids

A single dose of vaccine against the pandemic H1N1 influenza virus provides a strong immune response in healthy pregnant women, but studies confirm that two doses are required in children under 9, said Dr. Anthony Fauci, director of the NIAID
 

FOR IMMEDIATE RELEASE

PR Log (Press Release)Nov 03, 2009 – Neither finding was a surprise, but they validate the guidelines of current immunization programs. Pregnant women safely get "robust" protection from one dose of the H1N1 swine flu vaccine; but children under age 10 really need two doses, NIH studies show.The findings are straight-from-the-clinic data from ongoing studies funded and coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) at clinical centers across the country.

"This should be reassuring news to those women who already have received the H1N1 vaccine, and it is vital information for those pregnant women who have not been vaccinated," NIAID Director Anthony Fauci, MD, said at a news conference. "Importantly, the pregnant women participating in the trial have tolerated the vaccine well and no safety concerns have arisen."

"I am pleased to be able to share some good news. Nearly all the pregnant women who received a single 15-microgram dose had a robust immune response," said Fauci, adding that the one-dose regimen produced a robust immune response in 92 percent of the women.

Alarmingly, a recent CDC survey found that about half of pregnant women and other adults with risk conditions do not seek medical attention when they come down with H1N1 swine flu symptoms.

It's also becoming increasingly clear that H1N1 swine flu is mainly a disease of young people. Children, teens, and young adults bear the brunt of infections -- and of hospitalizations and deaths.

The NIAID clinical trials have shown that children, teens, and young adults over age 10 need just one dose of the H1N1 swine flu vaccine for protection.Early results from these studies suggested younger children might need two doses. That's true, new study results show.Even three weeks after getting their first dose of H1N1 swine flu vaccine, only 25% of kids ages 6 to 35 months and only 55% of kids ages 3 to 9 years are protected. Even giving these kids a one-time double dose did not improve immune responses.

Among children 6 months to 35 months old, 100 percent had a robust immune response eight to 10 days after the second dose of the vaccine, as did 94 percent of the children 3 years to 9 years of age, Fauci said.Earlier results from the trial had found that older children -- 10 to 17 years old -- needed only a single dose of the vaccine.

To date, the deaths of 114 children and 22 pregnant women have been positively linked to the swine flu, according to the U.S. Centers for Disease Control and Prevention.Meanwhile ,  Dr. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases, said Monday at the press conference that the shortage of H1N1 swine flu vaccine continues, because of variables with the egg-based production process.

"Expect continued challenges over the days ahead, but over time we expect that supply will start to increase and eventually catch up with the tremendous demand we are seeing now," she said. "It's getting better each day, but, unfortunately, it is not where we want it to be yet."


As of Friday, there were 26.6 million doses of vaccine in circulation, up from 16.1 million doses the week before, according to the CDC. First estimates by manufacturers had put the vaccine supply at 40 million doses by the end of October and 190 million by the end of the year.

Over the last several years, the federal government has invested in newer, faster ways to make vaccines, Fauci said. "But it takes years to get where we want to be," he said.

The current technology requires growing the virus in eggs, Fauci said. "There are many fragilities about that, one of which is that the virus is variable in its growth -- if we are lucky it grows very well and we have a good yield on time," he said.

Also Monday, independent health advisers were to begin monitoring the safety of the H1N1 vaccine, an extra preventive measure the federal government promised in this year's unparalleled program to watch for possible side effects, the Associated Press reported.

On Sunday, ABC News reported that a study published earlier this year that found N95 respirators were better than surgical masks at preventing flu had been retracted. The retraction came on the last day of the Infectious Diseases Society of America annual meeting, in Philadelphia.

After a re-analysis of the study that was prompted by questions from reviewers, the findings were deemed no longer significant, said Holly Seale of the University of New South Wales in Sydney, Australia. The lead author of the study, Raina MacIntyre, also of the University of New South Wales, did not attend the Philadelphia meeting.

Gellin also announced the release of a detailed plan to monitor the safety of the 2009 H1N1 swine flu vaccine.

Use of the CDC's Vaccine Safety Datalink system, which links data from eight managed-care organizations with data on 9 million Americans -- 3% of the U.S. population.

The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system, which links data from large insurance plans covering about 10% of the U.S. population.
Analysis of background rates of rare adverse events that occur without vaccination, to make it easier to determine whether vaccination increases the rate at which any of these events occurs.

A collaboration between Johns Hopkins University and the CDC in which people who received the H1N1 swine flu vaccine report their experiences via the Internet.

The Clinical Immunization Safety Assessment (CISA), a collaboration between six academic centers that will collect and store clinical samples from people who may be at risk for serious adverse events linked to vaccination or influenza.

The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), a collaboration between an association of birth-defect specialists, the American Academy of Allergy, Asthma, and Immunology, and Boston University, which will conduct studies of H1N1 swine flu vaccine, H1N1 swine flu antiviral treatment, and H1N1 swine flu disease.

(edited by Mark Anderson)

Swine Flu H1N1 cases are rising Significantly-CDC:http://genericdrugsonline.blogsome.com/2009/10/24/swine- ...

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Issued By:Mark Anderson
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Country:United States
Categories:Health, Science, Medical
Tags:swine flu, h1n1, Health, cdc, influenza
Last Updated:Nov 03, 2009
Shortcut:http://prlog.org/10398555

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