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H1N1 Vaccine Child Side Effects Report

FDA Permits Swine Flu Treatment With Unapproved Drug

Nov 2, 2009 Bernard P. Nelson

U.S. swine flu vaccine manufacturer provides results of H1N1 flu vaccine child clinical trials. FDA allows emergency use of FDA unapproved Peramivir 4 for swine flu.

The U.S. swine flu vaccine manufacturer and provider, Sanofi Pasteur, announced the results of the H1N1 vaccine child and infant clinical trials in a (author unknown) press release dated, October 14, 2009. The U.S. Centers for Disease Control states that the FDA unapproved drug Peramivir 4 will be used only for H1N1 hospitalized patients.

Sanofi Pasteur stated in their H1N1 child clinical trials press release, "The first clinical trial data from America’s youngest vaccine recipients, children 6 months through 9 years of age, show the vaccine induces an immune response and is well-tolerated. “

The Sanofi Pasteur press release, published on their website, says that the clinical trial data indicates that two doses of the vaccine should be administered to children under the age of 10 to prevent child swine flu symptoms. The title of the press release is “Sanofi Pasteur Announces Results of U.S. Clinical Trials of Influenza A (H1N1) Vaccine in Infants and Children.” The U.S. location of the manufacturer is Swiftwater, Philadelphia.

Swine Flu Vaccine Side Effects

Four hundred and seventy four children participated in the Sanofi Pasteur clinical trial, and were separated into two age groups. Two hundred and twenty nine children, aged six months through 35 months, were in the first group. Two hundred and forty five children, aged three years through nine years, were in the second group.

The clinical trial evaluated Sanofi Pasteur’s Influenza A 2009 Monovalent Vaccine in the children receiving the vaccine, and compared the results with the placebo group not receiving the vaccine.

The child clinical trial press release states that “No serious adverse events have been reported in the trial to date.” The press release did state that some vaccine reactions were observed which paralleled those typical reactions associated with the seasonal flu vaccine.

H1N1 Vaccine Ingredients

The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine, manufactured by Sanofi Pasteur, contains an “inactivated influenza virus.” The vaccine contains 15 mcg hemagglutinin (()HA) of the A/California/07/2009 H1N1 inactivated virus. In the single dose vials, the manufacturer claims that there are no preservatives. The multi-dose vials contain an (unnamed) preservative.

The vaccine is made the same way as the seasonal flu vaccine, and the manufacturer warns that the Monovalent Vaccine not be given to those “with a known severe hypersensitivity to egg proteins.”

Peramivir 4 for H1N1 Flu Infection or Influenza A

The U.S. Centers for Disease Control (CDC), providing swine flu vaccine recommendations, published an (author unknown) article on their website, dated October 29, 2009, titled, “Peramivir IV Questions and Answers for Health Care Providers.” The article states that due to the federal government declaring swine flu a “public health emergency,” the ”...FDA issued an Emergency Use Authorization authorizing the emergency use of the [FDA] unapproved drug Peramivir IV.”

The CDC states that Peramivir 4 will only be for “certain hospitalized adult and pediatric patients” that have been diagnosed with 2009 H1N1 flu infection or those with influenza A flu virus “...suspected to be 2009 H1N1 based on community epidemiology.” The unapproved drug is to be used on adult patients who are not responding to antiviral therapy, or other “appropriate circumstances.” Pediatric patients who do not respond to oral or inhaled antiviral therapy can be given Peramivir 4.

Peramivir 4 is an “intravenous neuraminidase inhibitor,” according to the CDC article. The drug inhibits the neuraminidase enzyme “...reducing the amount of virus in the body.” Peramivir 4 has not been proven to be effective for swine flu treatment, and there are “limitations to the safety and efficacy data...,” states the CDC.

Sanofi Pasteur, manufacturer of the swine flu vaccine for the U.S., states that there have been no serious side effects, to date, from children participating in the vaccine clinical trials. The CDC announcement to health care providers that the FDA unapproved drug Peramivir 4 is only to be used when other treatments fail for swine flu symptoms, and that there is no definite proof whether or not Peramivir will be effective for treating swine flu.

The copyright of the article H1N1 Vaccine Child Side Effects Report in General Medicine is owned by Bernard P. Nelson. Permission to republish H1N1 Vaccine Child Side Effects Report in print or online must be granted by the author in writing.

Influenza A Vaccine