Friday, August 27, 2010

Vaccines Flu Over 65 Lower Antibody Titers Safe Clinical Trials Influenza CA A-H1N1, A-Perth H3N2, and B-Brisbane Standard and High Dose 4X Higher Mus

Tags: Vaccines 2010, CA H1N1, A-Perth H3N2, B-Brisbane, Standard, Fluzone-High Dose Seniors,

… Persons aged ≥65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups,[1,2] and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults.[3]

The H1N1 Swine Bird Flu first appeared in 1918 and again in 1958. Luckily for the world, the H1N1 virus has been around for some time before the declared Pandemic. The virus attacked adults and young who were not six or older in 1958 and those who were not exposed in some form from the mother or any substance that causes our immune system to develop resistance to the virus.

In 1918 the Bird Flu Pandemic killed babies and young adults. During the current epidemic the H1N1 virus mutated at least 300 times. A careful study of these mutations showed that even though the virus guts mutated extensively, the attachment point structure remained largely the same so future mutations, unless we are unlucky will not kill many people. Our immune response is to the attachment structure. The Flu Death gene resides inside the whole structure present in the 1918 flu, but not the current H1N1 virus.

Not often mentioned or appreciated is that the immune response of younger children and adults is often quite strong which produces lots of Cytokines which causes inflammation at the infection site. It is especially bad in the lungs because cytokines also bring lots of water with it. Many die from bacterial pneumonia, a form of drowning.

The reason that so many young children infected with H1N1 e-coli in hamburgers have their kidneys shut down is that cytokines in large amounts damage organs too. When the SARS virus was killing essentially everyone who got infected in Hong Kong, the nurses and doctors were dying too! Someone realized that patients had to be treated with massive doses of Prednisone to ramp down the immune response of the patients.

Luckily about half of the critical patients with H1N1 got Prednisone or more would have died. How about the other half? They must have read the "smart" Harvard article analyzing the Chinese doctors use of Prednisone and declared the results invalid! These smart guys forgot that the doctors were not doing a research study, they were trying and did save their patients!

For the first time in many years, influenza B has been added to the seasonal vaccine, and also another mutant form of influenza A-Perth H3N2. I am now not aware of the history of these flu viruses so I cannot advise you how dangerous they may be.

Incompetence of those running the CDC and its political head did not realize that seniors died from seasonal flu because the vaccine did not work well because an older person’s immune system may have been too weak to develop resistance to the flu virus. This is seen often in young children younger than six and so the Obama administration clinically tested the new vaccines on both young children, pregnant mothers, and was extended to seniors for this year to determine dose in recommendations.

This led to the High Dose Vaccine which is four times the dose previously used. Side effects increased to 1.1 percent may produce fevers as high as 102 degrees and rarely over this. Side Effects will be monitored very close as the early vaccinations start in September instead of the usual October. I plan to get the vaccine in late September when I see my doctor for other tests. It will be injected into the muscles for slower release.

Let logic and information influence whether you get vaccinated or not. I strongly recommend the former no matter what the fear mongering crowd does.

Jim Kawakami, August 27, 2010, http://jimboguy.blogspot.com

Abstract and Introduction

Introduction

http://www.medscape.com/viewarticle/721317?sssdmh=dm1.634157&src=journalnl&uac=26057PR Persons aged ≥65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups,[1,2] and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults.[3]

On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone.

Fluzone High-Dose is licensed as a single dose for use among persons aged ≥65 years and will be available beginning with the 2010–11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines.[4] This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.

Standard dose inactivated trivalent influenza vaccines contain a total of 45 µg (15 µg of each of the three recommended strains) of influenza virus hemagglutinin antigen per 0.5mL dose.[5]

In contrast, Fluzone High-Dose is formulated to contain a total of 180 µg (60 µg of each strain) of influenza virus hemagglutinin antigen in each 0.5mL dose. Like other inactivated influenza vaccines, Fluzone High-Dose is administered as an intramuscular injection.[6] Fluzone High-Dose is available as a single-dose prefilled syringe formulation and is distinguished from Fluzone by a gray syringe plunger rod. As with other 2010–11 influenza vaccines, Fluzone High-Dose will contain antigens of the three recommended virus strains: A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like.[7]

Immunogenicity data from three studies among persons aged ≥65 years indicated that, compared with standard dose Fluzone, preparations of Fluzone High-Dose elicited significantly higher hemagglutination inhibition (HI) titers against all three influenza virus strains that were included in seasonal influenza vaccines recommended during the study period.[8–10]

In one study, prespecified criteria for superiority, defined as when the lower 95% confidence limit of 1) a ratio of geometric mean HI titers is >1.5 for at least two strains and 2) the difference in fourfold rise of HI titers is >10% for at least two strains, were demonstrated for persons aged ≥65 years who received Fluzone High-Dose compared with Fluzone for influenza A(H1N1) and influenza A(H3N2) antigens.

Prespecified criteria for noninferiority to Fluzone were demonstrated for the influenza B antigen.[6,9] Whether the higher postvaccination immune responses observed among Fluzone High-Dose vaccine recipients will result in greater protection against influenza illness is unknown.

Solicited injection site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared with standard Fluzone, but typically were mild and transient.[8–10] In the largest study, 915 (36%) of 2,572 persons who received Fluzone High-Dose, compared with 306 (24%) of 1,275 persons who received Fluzone, reported injection site pain ≤7 days after vaccine administration.

In the same study, significantly more Fluzone High-Dose recipients (1.1%) reported moderate (>100.4°F–≤102.2°F [>38°C–≤39°C]) to severe (>102.2°F [>39°C]) fever, compared with Fluzone recipients (0.3%).[9]

ACIP Guidance for Use of Fluzone High-dose

Fluzone High-Dose may be used for persons aged ≥65 years. All persons aged ≥6 months are recommended for annual influenza vaccination beginning with the 2010–11 influenza season. ACIP has not expressed a preference for any specific licensed inactivated trivalent influenza vaccine, including Fluzone High-Dose, for use in persons aged ≥65 years.[4] Data demonstrating greater protection against influenza illness after vaccination with Fluzone High-Dose are needed to evaluate whether Fluzone High-Dose is a more effective vaccine for persons aged ≥65 years.

A 3-year postlicensure study of the vaccine effectiveness of Fluzone High-Dose compared with standard dose inactivated influenza vaccine (Fluzone) was begun in 2009 and should be completed in 2012. As with other inactivated influenza vaccines, Fluzone High-Dose should not be administered to anyone with a known hypersensitivity to egg proteins or influenza vaccine. Adverse events after receipt of any vaccine should be reported to the Vaccine Adverse Event Reporting System at http://vaers.hhs.gov.

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