http://www3.niaid.nih.gov/news/newsreleases/2009/interimpedsdata.htm
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.
The interim results include data from all available samples from the 583 children enrolled into the trial, and build upon the preliminary results released September 21 from a subset of volunteers. Those early results, based on blood samples taken eight to 10 days following the first injection, showed that in the majority of children 10 years of age and older, a single 15-microgram dose of vaccine elicited a strong immune response. In contrast, most of the younger children did not respond strongly to one dose of either 15 or 30 micrograms of vaccine.
The new data, obtained eight to 10 days after the second vaccine dose, are compared here with results obtained 21 days after the first vaccine dose:
* Among the youngest children (6 to 35 months), 100 percent had a robust immune response after the second 15-microgram dose compared with only 25 percent three weeks after the first dose.
* In children aged 3 through 9 years old, 94 percent had a robust response after the second 15-microgram dose compared with only 55 percent three weeks after the first dose.
* In general, the immune responses in children receiving two 15-microgram doses and those receiving two 30-microgram doses of vaccine were similar, suggesting that receipt of two 15 microgram doses is adequate to elicit a strong immune response.
Analysis continues on the data from this trial, and additional findings will be provided as they become available.
Additional information about this and other NIAID-sponsored trials of 2009 H1N1 influenza vaccines are available at the NIAID's H1N1 Flu page.
http://www3.niaid.nih.gov/topics/Flu/H1N1/Research/
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 http://www.nih.gov.
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Damn, hey?
XOXO
Me
Anne this concerns me. I hate to put the thought out there but I am sure others have thought the same thing. But what if this flu was not "just" a flu? What if the whole thing was created to affect the younger people in order to destroy our future generations? What if it was a virus left over from the earlier times of history and kept somewhere to be brought back on purpose?
ReplyDeleteAnd to give the kids a second dose of something we really are not all that sure about to begin with worries me that it will have long term side affects. If the child survives the flu after coming so close to death, will they ever be able to reproduce and have children of their own some day? This is something we will have to wait another 5 to 20 years maybe to find out. But what if? The ones being affected the most by the flu right now are the very ones our world will need to carry on the future with. If they all become sterile.....well....?? Yes....they will live to carry on...but if our kids can't have kids then something is intent on destroying mankind.
Peachie;
ReplyDeleteI highly doubt that this will be a problem... Remember, in the 50's and 60's we were all afraid of the "pinko commies". And THOSE fears led to many more problems than what we would have ever guessed with respect to overcoming all the negatives about foreign countries, (and other governments, religions etc).
From here: http://www.fox11online.com/dpp/mobile/local_wluk_brown_county_h1n1_vaccines_coming_slower_than_expected_200910161605_rev1
Brown County's health director says that the vaccine arrival could still be several weeks away.
"We understand from the state the vaccines are coming out slower than they expected."
"While not everyone believes getting the vaccine is the right thing to do...
Some people are saying that they are afraid to get the h1n1 shot- They think this is a new vaccine of some kind.
It's really NOT. It's a new strain of vaccine against a new type of flu.
But the vaccine itself has been out there for years and years."
I would be much much more afraid of catching the flu than of the vaccine.
It is imperative to get the vaccine.
Do not be afraid of your fears. Restated, be MORE afraid of catching this flu.
XOXO
Me
http://www.fda.gov/
ReplyDeleteCommon Ingredients in U.S. Licensed Vaccines
October 23, 2009
Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients
The Description and Ingredients information on this page is excerpted from the package inserts for each of the licensed Influenza A (H1N1) 2009 Monovalent Vaccines. Click on the below "Package Insert" links to view the complete original documentation provided by each manufacturer.
INJECTIBLE VACCINES
CSL Limited
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg HA per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus.
The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms).
The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.
Package Insert - CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine
Novartis Vaccines and Diagnostics Limited
Influenza A (H1N1) 2009 Monovalent Vaccine is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.
The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
The multidose vial stopper and the syringe stopper/plunger do not contain latex.
Package Insert - Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine
Sanofi Pasteur, Inc.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).
There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine.
All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex.
Package Insert - Sanofi Pasteur, Inc Influenza A (H1N1) 2009 Monovalent Vaccine
INTRANASAL (NASAL SPRAY)
MedImmune LLC
Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer co
http://www.fda.gov/
ReplyDeleteCommon Ingredients in U.S. Licensed Vaccines
October 23, 2009
The vast majority of the over one billion doses of vaccines manufactured worldwide each year are given to healthy babies, children and adults. Thus, it is critical that vaccines be demonstrated to be safe and effective. FDA demands that vaccines undergo a rigorous and extensive development program in the laboratory, as well as in animal studies and human clinical trials, to determine their safety and effectiveness. Highly trained FDA scientists and clinicians carefully review all the information in a marketing application before approval and use by the public. Prior to licensure, as part of FDA’s review, FDA takes all the ingredients into account, including the active ingredients as well as other substances. After FDA approves a vaccine, FDA and CDC continuously monitor its safety.
Why is aluminum in some vaccines?
Aluminum salts are incorporated into some vaccine formulations as an adjuvant to enhance the immune response in the vaccinated individual. The aluminum salts in some U.S. licensed vaccines are aluminum hydroxide, aluminum phosphate, alum (potassium aluminum sulfate), or mixed aluminum salts. For example: aluminum salts are used in DTaP vaccines, the pneumococcal conjugate vaccine, and hepatitis B vaccines.
Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. Of note, the most common source of exposure to aluminum is from eating food or drinking water.
Are other adjuvants used in US vaccines?
Yes, there is one other adjuvant used in one U.S. licensed vaccine. Cervarix, a vaccine licensed by FDA on October 16, 2009, to prevent cervical cancer caused by human papillomavirus types 16 and 18, includes AS04 in its formulation. AS04 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL). MPL is a purified fat-like substance.
How does FDA evaluate adjuvants for safety and efficacy?
When evaluating a vaccine for safety and efficacy, FDA considers adjuvants as a component of the vaccine; they are not licensed separately.
Why are antibiotics in some vaccines?
Certain antibiotics may be used in some vaccine production to help prevent bacterial contamination during manufacturing. As a result, small amounts of antibiotics may be present in some vaccines. Because some antibiotics can cause severe allergic reactions in those children allergic to them (like hives, swelling at the back of the throat, and low blood pressure), some parents are concerned that antibiotics contained in vaccines might be harmful. However, antibiotics most likely to cause severe allergic reactions (e.g., penicillins, cephalosporins and sulfa drugs) are not used in vaccine production, and therefore are not contained in vaccines.
Examples of antibiotics used during vaccine manufacture include neomycin, polymyxin B, streptomycin and gentamicin. Some antibiotics used in vaccine production are present in the vaccine, either in very small amounts or they are undetectable. For example, antibiotics are used in some production methods for making inactivated influenza virus vaccines. They are used to reduce bacterial growth in eggs during processing steps, because eggs are not sterile products. The antibiotics that are used are reduced to very small or undetectable amounts during subsequent purification steps. The very small amounts of antibiotics contained in vaccines have not been clearly associated with severe allergic reactions.
Why is formaldehyde in some vaccines?
Formaldehyde has a long history of use in the manufacture of certain viral and bacterial vaccines. It is used to inactivate viruses (e.g., influenza, polio) and to detoxify bacterial toxins, such as the toxin used to make diphtheria vaccine. Formaldehyde is diluted during the manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines. The average q
Anne...I'm in the south. What was "pinko commies?" Never heard that expression for what we experienced here. Is this referring to the times when we were so close to nuclear war with the communists? Yes..I do remember the "tests" and the "what to do if this happens" routines. What cave or underground building to go to "just in case." Is this what you mean? I was born in April '54, and I live less than an hour from Redstone Arsenal. Back then, Redstone was one of the target places for those "just in case" moments. Well....it sorta still is. But yes...I do remember those constant "drills." LOL! Like any of it would have mattered if something actually did happen.
ReplyDeleteSorry to stray from the point. But you threw me with the "pinko commie" phrase. LOL!
That is what I meant. Sorry for the "cornf00sion"
ReplyDeletehehehe
XOXO
Me
PS
You must have just slid in there- I was born in '58 and cannot remember those drills.
(Just the weather and fire ones).