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HHS Science Briefing

 

 

# 3935

 

The HHS has just concluded a science briefing held with Dr. Anne Schuchat, Director of of the CDC's National Center for Immunization and Respiratory Diseases and by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Dr. Bruce Gellin, the director of the National Vaccine Program Office.

 

The purpose of the meeting was to bring us up to date on recent NIAID clinical trials conducted on the H1N1 vaccine involving healthy pregnant women, and healthy children under the age of 10, and to answer reporter’s questions about vaccine safety.

 

With pregnant women, the good news is a single 15 µg vaccine dose provoked a robust immune response in 92% of the subjects tested.  A 30 µg dose was only slightly more effective (96%).

 

Among children under the age of 10, two doses of H1N1 vaccine, given roughly 4 weeks apart, provoked a robust immune response.

 

Children between the ages of 6 and 35 months only saw a robust response after 1 dose 25% of the time, and children aged 3 to 9 years, only 55% of the time.

 


Therefore, the recommendation remains that children under the age of 10 receive two doses of the vaccine. 

 

More details are available from these two press releases, available from the NIAID website.

 

 

Monday, Nov. 2, 2009

Media Contact: NIAID Office of Communications
(301) 402-1663
niaidnews@niaid.nih.gov

Initial Results Show Pregnant Women Mount Strong Immune Response To One Dose of 2009 H1N1 Flu Vaccine

Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

 

“For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring,” says NIAID Director Anthony S. Fauci, M.D.  “The immune responses seen in these healthy pregnant women are comparable to those seen in healthy adults at the same time point after a single vaccination, and the vaccine has been well tolerated.”

 

According to the Centers for Disease Control and Prevention, since the outbreak began last spring, at least 100 pregnant women have been hospitalized in intensive care units in the United States and at the last official count, 28 pregnant women have died.

 

A preliminary analysis of blood samples taken 21 days post-vaccination from a subgroup of 50 pregnant women participating in the trial shows the following:

  • In 25 women who received a single 15-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 92 percent, or 23 of 25, of these women. 
  • In 25 women who received a single 30-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 96 percent, or 24 of 25, of these women.

(Continue . . .)

 

 

 

November 2, 2009
BULLETIN

 

Updated Results: In Youngest Children, a Second Dose of 2009 H1N1 Influenza Vaccine Elicits Robust Immune Response


The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced interim results that show that children nine years of age and younger have a significantly improved immune response when given a second 15-microgram dose of 2009 H1N1 influenza vaccine.


The clinical trial evaluated the immune response of children six months to 17 years of age who received two doses of either 15 or 30 micrograms of 2009 H1N1 influenza vaccine. One of the most important findings from this study is that among children nine years old and younger, the second dose elicited a robust immune response after eight to 10 days, a significant improvement over the immune responses in this age group following only a single dose.

 
These findings support the current recommendation of the Advisory Committee on Immunization Practices (ACIP), which sets U.S. recommendations for all immunizations: To achieve an immune response likely to protect from illness, children nine years of age and younger should receive two 15-microgram doses of 2009 H1N1 vaccine. The trial data also continue to support the recommendation that children ten years of age and older should receive only one 15-microgram dose of vaccine.

(Continue . . .)

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