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Swine flu vaccine is being pushed for children/pregnant women but has not been tested

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annsni

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According to the US News and World Report:

"If the H1N1 flu outbreak doesn’t peak until midwinter, it could be curtailed with a staggered vaccination program that begins with children and ultimately targets 70 percent of the population, researchers report online September 10 in Science. "

"Current estimates suggest that between 45 million and 52 million doses of vaccine will be ready by mid-October, with another 195 million by the end of the year. Longini and his colleagues find that because children will experience the highest infection rates they should receive vaccines first. Vaccinating other at-risk groups, such as health care workers and those with compromised immune systems, is also important. Given the pattern of spread among connected people, the researchers suggest that vaccinating 70 percent of the U.S. population will contain the virus."

"If the pandemic flu peaks earlier in October, a vaccination program that targets children would need to be launched as soon as possible, the new analysis in Science concludes.
The new work is well done and highlights the importance of vaccinating children, says Jan Medlock, a mathematical biologist at Clemson University in South Carolina. Close quarters with multiple peers and more liberal personal hygiene policies make kids more likely to carry germs. Vaccinating kids protects them and reduces disease transmission, protecting others, he says.
Compared with most influenza viruses, the H1N1 pandemic flu has also caused more disease in people under age 25 than in older people, perhaps because older people have some preexisting immunity to this strain. That offers another reason to focus initial vaccine efforts on younger people."

all from http://www.usnews.com/articles/scie...vaccination-should-target-children-first.html

Additionally, pregnant women should receive the vaccine:

ATLANTA - Swine flu has been hitting pregnant women unusually hard, so they are likely to be among the first group advised to get a new swine flu shot this fall.
Pregnant women account for 6 percent of U.S. swine flu deaths since the pandemic began in April, even though they make up just 1 percent of the U.S. population.
On Wednesday a federal vaccine advisory panel is meeting to take up the question of who should be first to get swine flu shots when there aren't enough for everyone. At the top of the list are health care workers, who would be crucial to society during a bad pandemic.

But pregnant women may be near the top of the list because they have suffered and died from swine flu at disproportionately high rates.

"Experts believe an effective vaccine would benefit not only a pregnant woman but also her unborn child."

from "http://www.msnbc.msn.com/id/32184356/


However, here's from the vaccine insert:


8.1 Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers
Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

8.4 Pediatric Use
Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.



Unbelievable.
 

donnA

Active Member
they want to give children and pregnant women a vaccine that has not been tested?
this isn't even legal is it?
 

annsni

Well-Known Member
Site Supporter
they want to give children and pregnant women a vaccine that has not been tested?
this isn't even legal is it?

Apparently it is. And not just want to give it to them but highly recommending it and promoting it! THAT is so scary!
 

Johnv

New Member
This is a nonissue. The H1N1 flu vaccine has been tested in the same manner that other flu vaccines are tested. The "Pregnancy", "Nursing Mothers" and "Pediatric Use" alerts locted on the insert are the same that one finds on the common flue vaccines every year. Expectant mothers, children, and elderly are the highest risk groups for common flu every year, and every year they are encouraged to be vaccinated. H1N1 is no different.
 

annsni

Well-Known Member
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This is a nonissue. The H1N1 flu vaccine has been tested in the same manner that other flu vaccines are tested. The "Pregnancy", "Nursing Mothers" and "Pediatric Use" alerts locted on the insert are the same that one finds on the common flue vaccines every year. Expectant mothers, children, and elderly are the highest risk groups for common flu every year, and every year they are encouraged to be vaccinated. H1N1 is no different.

However, the H1N1 vaccine in the past has had very different side-effects than the standard seasonal flu vaccine, has it not?
 

donnA

Active Member
it's now legal to give untested rugs to people? how do drugs like this get passed on to the public, we've seen in the pst drugfs take years of testing to get approval. now this, untested drugs given to epople. thats not good.
 

Johnv

New Member
However, the H1N1 vaccine in the past has had very different side-effects than the standard seasonal flu vaccine, has it not?
There haven't been any side effects at all. The New England Journal of Medicine reports that that not only have the results been highly effective, but no adverse effects have been reported.
it's now legal to give untested rugs to people?
That's a misrepresentation of the facts on how testing is performed. The nature of how a vaccine functions makes it unnecessary to perform testing on variations in population unless there's an indicator that the effects will be different. Flu vaccines fit into that category.
 
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annsni

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There haven't been any side effects at all. The New England Journal of Medicine reports that that not only have the results been highly effective, but no adverse effects have been reported.

What is the size of the study? How many were tested?
 

Johnv

New Member
NEJoM actually cited numerous studies. Between all the different studies done by now, there have at this point been clost to ten thousand people in study groups.

The rules of statistical analysis dictate that a pattern can be predicted with as little as a few hundred samples, and a permanent pattern can be demonstrated with as little as 1500 samples. This is true of any statistic. In other words, whether the number studied is 1500 people, or 150,000 people, the numeric result is the same (anyone reading this who hastaken a statistical analysis class in college will confirm that). H1N1 statistical analysis is well past that.
 

Revmitchell

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What is the size of the study? How many were tested?

http://content.nejm.org/cgi/content/full/NEJMoa0907650


Background The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.

Methods We conducted a single-center study, involving 175 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 µg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-µg doses of MF59-adjuvanted vaccine, or 7.5 or 15 µg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.

Results Results of an interim analysis of the responses to the 7.5-µg dose of MF59-adjuvanted vaccine by days 14 and 21 are presented (data from four of the seven groups studied, for a total of 100 subjects). The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively. Two subjects reported fever, with a temperature of 38°C or higher, after the first dosing. Antibody titers, expressed as geometric means, were generally higher at day 14 among subjects who had received two 7.5-µg doses of the MF59-adjuvanted vaccine than among those who had received only one by this time point (P=0.04 by the hemagglutination-inhibition assay and P<0.001 by the microneutralization assay). By 21 days after vaccination with the first dose of 7.5 µg of MF59-adjuvanted vaccine, the rates of seroconversion, as measured with the use of a hemagglutination-inhibition assay and a microneutralization assay, were 76% and 92% of subjects, respectively, who had received only one dose to date (with the second dose scheduled for day 21) and 88 to 92% and 92 to 96% of subjects, respectively, who had already received both doses (P=0.11 and P=0.64, respectively).
 
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Revmitchell

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What is the size of the study? How many were tested?


According to the CDC no tests are final but are in the process as of Sept 18:

Q: What safety studies have been done on the 2009 H1N1 influenza vaccine and have any been done in pregnant women?

A: A number of clinical trials which test 2009 H1N1 influenza vaccine in healthy children and adults are underway. These studies are being conducted by the National Institutes of Allergies and Infectious Diseases (NIAID). Studies of 2009 H1N1 influenza vaccine in pregnant women are expected to begin in September.

Q: What are the possible side effects of the 2009 H1N1 influenza vaccine?

A. The side effects from 2009 H1N1 influenza vaccine are expected to be similar to those from seasonal flu vaccines. The most common side effects following vaccination are expected to be mild, such as soreness, redness, tenderness or swelling where the shot was given. Some people might experience headache, muscle aches, fever, nausea and fainting. If these problems occur, they usually begin soon after the shot and may last as long as 1-2 days. Like any medicines, vaccines can cause serious problems like severe allergic reactions. However life-threatening allergic reactions to vaccines are very rare. In 1976, an earlier type of swine flu vaccine was associated with cases of a severe paralytic illness called Guillain-Barre Syndrome (GBS) at a rate of approximately 1 case of GBS per 100,000 persons vaccinated. Some studies done since 1976 have shown a small risk of GBS in persons who received the seasonal influenza vaccine. This risk is estimated to be no more than 1 case of GBS per 1 million persons vaccinated. Since then, flu vaccines have not been clearly linked to GBS. GBS has a number of different causes, and GBS can occur in a person who has never received an influenza vaccine. The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death substantially outweigh these estimates of risk for vaccine-associated GBS.

Anyone who has a severe (life-threatening) allergy to eggs or to any other substance in the vaccine should not get the vaccine. People should always inform their immunization provider if they have any severe allergies, if they’ve ever had a severe allergic reaction following flu vaccination, or if they have ever had GBS.
 
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Johnv

New Member
It's not just one study. There have been several. This is just one of many. So far, all studies have been consistent.
 

annsni

Well-Known Member
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Is that Chicken Little I hear yelling again?

I would just like to see some decent testing on a vaccine before it's fast-tracked and pushed so much and even forced on some people. If the insert in the vaccine itself says that it's not been tested on pediatric or pregnant patients, how can we be sure it's safe?

My family gets the standard flu shot but even my pediatrician will not provide this shot because of the lack of good testing.
 

Johnv

New Member
I would just like to see some decent testing on a vaccine before it's fast-tracked and pushed...
Current testing is consistent with flu vaccine testing done every year every year. This is no different. This is a nonissue.
If the insert in the vaccine itself says that it's not been tested on pediatric or pregnant patients, how can we be sure it's safe?
It's the same insert found with the common seasonal flue vaccine. Again, this is no different. Again, this is a complete nonissue. There's no need to test it on one-legged dog catchers or Eskimo fisherman either, btw.
Well, the good news is...recommended. Not required by law. For now we still have freedom not to vaccinate.
Absolultely right. Since I travel for work a lot, I will be getting vaccinated as soon as reasonably possible. However, I have no plans to vaccinate my children for H1N1 or the common seasonal flu.
 
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