ＣＤＣのDr. Anne Schuchatインフルエンザ部長は、2回目の接種時に同時に季節性インフルエンザワクチン接種をすることは可能であるという。しかし、鼻スプレーフォームのワクチンは同時接種はすべきでないとした。鼻スプレーワクチンFluMistは弱毒生ワクチンのためリスクがやや多く2才未満の小児や喘息の子どもは推奨しない。
One Shot of Vaccine Can Protect Most Children
By DONALD G. McNEIL Jr.
Published: September 21, 2009
A single shot of swine flu vaccine appears to protect most children and teenagers nearly as well as it protects adults, federal health officials said Monday.
Young children who have never had the flu or a flu shot, however, need two doses, they said. So, to fully protect them against both swine and seasonal flu this year, those children will need four shots.
“I’m pleased to bring you more good news,” Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters on Monday in a telephone news conference about the trials of the new vaccine his agency is overseeing. On Sept. 10, he reported that adults were protected by a single shot, rather than the two that many experts had predicted; the announcement effectively doubled the nation’s supply of swine flu vaccine and halved the paperwork.
Preliminary results of the next round of trials, in pregnant women, are expected next month.
The latest trials, done in about 600 children and teenagers, ages 10 to 17, found that they received a “robust immune response” from a single dose, Dr. Fauci said. (Specifically, after 10 days, 76 percent had enough antibodies in their blood to be considered immune to swine flu. While that is not 100 percent protection, some could be expected to develop more antibodies after 10 days, and 76 percent is considered “not bad at all” for flu vaccine, Dr. Fauci added.)
Children 6 months to 9 years old received some protection from one shot, but not enough, so health officials will recommend that they get two shots 21 days apart.
“This is not an unexpected finding and is in accordance with what we find with seasonal flu vaccine,” Dr. Fauci said.
Because young children have immature immune systems, pediatricians usually give them two shots the first time they administer flu vaccine. After that, annual shots act as boosters.
Doctors can give both the swine and seasonal flu shots in a single visit and then the two together again 21 days later, said Dr. Anne Schuchat, director of the flu division of the Centers for Disease Control and Protection. But they should not give more than a single dose of either vaccine in nasal spray form at one time, she added.
Nasal spray vaccine, known as FluMist, uses a weakened live virus, which gives more protection but carries slightly more risk and so is not recommended for children under 2 or children with asthma or who wheeze.
Seasonal flu vaccine has already been shipped, and health officials are urging Americans to get it right away. The first doses of swine flu vaccine are expected to become available in early October. The initial 3.4 million doses will be in nasal spray form, but the injectable versions are expected one to two weeks later.
There were no serious reactions to the vaccine among the 600 children tested, Dr. Fauci said. Some complained of sore arms or mild fevers, he said, but that is typical for flu shots.
For Immediate Release
Monday, September 21, 2009
NIAID Office of Communications
Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine
Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine ― the same dose that is in the seasonal flu vaccine ― generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.
"This is very encouraging news," says NIAID Director Anthony S. Fauci, M.D. "As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results."
The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide. The trial is assessing the safety and immune responses to one and two doses of either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being compared for three age groups: children 6 months to 35 months old; 3 to 9 years old; and 10 to 17 years old.
The preliminary results are based on blood samples taken eight to 10 days after the first vaccination. Immune responses were strongest among the oldest children, those 10 to 17 years old. In this group of 25 children, a strong immune response was seen in 76 percent who received one 15-microgram dose of vaccine. The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.
"These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated," notes Dr. Fauci.
Study investigators are also collecting blood samples from the volunteers approximately three weeks after both the first and second injections. It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will be similar to that of seasonal influenza vaccination and will continue to rise for several weeks following vaccination, says Dr. Fauci. The study is being closely monitored by the trial physicians and staff as well as by an independent safety monitoring committee.
The vaccine being tested in this trial is manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu.
NIAID is conducting trials of 2009 H1N1 influenza vaccines through its longstanding vaccine clinical trials network, the Vaccine and Treatment Evaluation Units. Additional information about the NIAID-sponsored clinical trials in children is available in an Aug. 18 Bulletin: http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pedvax.htm and a Q&A: http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm. A detailed description of the trial protocol is at clinicaltrials.gov: http://clinicaltrials.gov/show/NCT00944073.
For more information on influenza, including pandemic influenza and avian influenza, visit www.flu.gov. Also, see NIAID’s Web portal at http://www3.niaid.nih.gov/topics/Flu/.
NIAID conducts and supports research ― at NIH, throughout the United States, and worldwide ― to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
The National Institutes of Health (NIH) ― The Nation's Medical Research Agency ― includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
One H1N1 Vaccine Dose May Suffice for Older Children One H1N1 Vaccine Dose May Suffice for Older Children
Posted by Journal Watch Editors • September 22nd, 2009 • Printer-friendly
Children aged 10 to 17 may need to receive only one dose of the vaccine against 2009 H1N1 influenza, preliminary results from the NIH indicate. Younger children do not show as strong an immune response with a single dose.
In blood samples taken 8 to 10 days after vaccination with a single 15-µg dose, the following percentages of children showed a robust immune response, which is generally predictive of protection:
* 76% of those aged 10 to 17 years
* 36% of those aged 3 to 9 years
* 25% of those aged 6 to 36 months
Children 6 months to 9 years of age may need two doses of the vaccine, NIAID Director Dr. Anthony Fauci told Physician’s First Watch.
Dr. Fauci said: “These results are not unexpected and are … similar to what is seen with seasonal influenza vaccines.”
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