Here in Canada we have already spent 1.5 billion vaccinating the high priority people, it is expected to go well over 2 billion (flu shot here is free). I work for a school board and they have taken custodians off their regular jobs to go around and wipe all door knobs, sink fixtures and other surfaces touched regularly twice a day, what a waste of time and money. I would be interested to know how much this will cost the government and business's at the end of the day.
everything is kind of getting ridiculous.
BC Soccer Association forwarded an email 2 weeks ago we're not allowed to shake hands after the games anymore. We have to stand across the field and wave "good game" like idiots.
you have to be joking.
not joking.
there are also hand sanitizers everrywherrre
As a person who supposedly represents medical opinion to people on the internet, TravisTheSky, PLEASE read and represent the whole story.
The package insert to which you refer states that "Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine" from that manufacturer - and they say this to cover their own asses.
While no one is saying here that we possess ALL possible knowledge about this vaccine (or any other medical issue), the FDA has judged - based on the knowledge they have about the safety of other flu vaccines produced in the exact same way, as well as lack of any information to the contrary - that the H1N1 vaccine is safe for pregnant women. And - based on all the knowledge we have about how H1N1 is having a disproportionately adverse effect on pregnant women - the FDA, CDC, & ACIP all agree that it is more beneficial than risky for pregnant women to get this shot.
Translation: We have no reason to believe that the H1N1 vaccine is harmful to pregnant women and every reason to believe that the H1N1 flu is especially harmful to pregnant women. We also know that the H1N1 vaccine is protective against the H1N1flu. So, according to the very best of our knowledge, pregnant women should get vaccinated.
Analogy: Saying pregnant women shouldn't get the H1N1 vaccination because there haven't been reproduction studies done in animals for this specific version of the flu vaccine is like saying pregnant women shouldn't eat broccoli - despite all its known benefits - because we haven't specifically tested the effects of broccoli on pregnancy. Or like saying blondes shoudln't wear seat belts because we haven't specifically tested the effects of seat belts on blonde people. (Okay, that last one is a little bit of a stretch. But only a little, and hopefully it gets the point across.)
correct me if i'm wrong but i thought the FDA didn't actually do any research themselves, they simply accept what's given to them by the company pushing their product....
I’m not sure I understand your point or what you mean by “do” the research, but it sounds below like the research is done through / overseen by the FDA:
FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.
Vaccine clinical development follows the same general pathway as for drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included are information about the vaccine's safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as the proposed clinical protocol for studies in humans.
Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic. Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects. Finally, Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or effectiveness, FDA may request additional information or studies, or may halt ongoing clinical studies.
If successful, the completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA). To be considered, the license application must provide the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists, biostatisticians, etc.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine. Also during this stage, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail.
Following FDA's review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.
Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine's proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.
The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also required to submit samples of each vaccine lot to the FDA for testing. However, if the sponsor describes an alternative procedure which provides continued assurance of safety, purity and potency, CBER may determine that routine submission of lot release protocols (showing results of applicable tests) and samples is not necessary.
Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.
References
• National Vaccine Advisory Committee. "United States Vaccine Research: A Delicate Fabric of Public and Private Collaboration." Pediatrics, Vol 100(6), Dec.1997, pp. 1015-1020.
• Parkman PD, Hardegree MC. "Regulation and Testing of Vaccines." In Plotkin SA, Orenstein WA, [eds.]. Vaccines, 3d ed. Philadelphia: Saunders; 1999, pp.1131-1143.
• Stehlin, Isadora. "How FDA Works to Ensure Vaccine Safety." FDA Consumer Magazine, March 1996.
what i mean by "do" the research is they, the FDA, don't conduct any research or tests themselves, they simply look over the test results that were given to them.
as your article stated
the license application must provide the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists, biostatisticians, etc.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine.
they review the research and tests handed to them by the company trying to get their product approved and the FDA looks it over and makes a risk/benefit assessment
don't compete; coexist
what are you but my reflection? who am i to judge or strike you down?
"I will promise you this, that if we have not gotten our troops out by the time I am president, it is the first thing I will do. I will get our troops home. We will bring an end to this war. You can take that to the bank." - Barack Obama
when you told me 'if you can't beat 'em, join 'em'
i was thinkin 'death before dishonor'
I got the regular flu about 3 years ago and ended up in hospital. I got that vaccine ever since, but not the swine one. It seems to be affecting kids. I know lots of schools around here have about half their regular attendance.
I got the regular flu about 3 years ago and ended up in hospital. I got that vaccine ever since, but not the swine one. It seems to be affecting kids. I know lots of schools around here have about half their regular attendance.
Do the schools have half their regular attedance because kids are getting vaccinated or because they're getting the flu?
The vaccine just became availabel to high risk people (including kids) about 2 weeks ago here. I got my daughter the vaccination.
As far as schools...eralier in the fall some schools had 1/2-2/3 of their population out sick. Now, not so much. So, at least in my area, the vaccination are not causing kids to become ill in great numbers as someone seems to be suggesting.
I find it funny that some of the same people that promote national health care based upon the fact that people will then be able to get PREVENTATIVE care are the same people against getting vaccinations.
I find it funny that some of the same people that promote national health care based upon the fact that people will then be able to get PREVENTATIVE care are the same people against getting vaccinations.
Why is that?
why would it be funny? ... is it funny because people are not behaving in a preconceived manner?
I find it funny that some of the same people that promote national health care based upon the fact that people will then be able to get PREVENTATIVE care are the same people against getting vaccinations.
Why is that?
why would it be funny? ... is it funny because people are not behaving in a preconceived manner?
Ummm...funny because people arguing for preventative care are criticizing preventative care.
It seems like wanting your cake and eating it too.
Ummm...funny because people arguing for preventative care are criticizing preventative care.
It seems like wanting your cake and eating it too.
both things are open to interpretation in my mind ... some people say drinking milk makes for strong bones and prevents osteoperosis (sp?) while some people don't ... i'm not too sure which people you are referring to in this thread but i know i'm in favour of public health care and i am choosing not to take the shot ...
for me - i like the idea that if i get hit by a car on my bike i'm not gonna have to worry about paying for my hospital visit ... whereas - my risk/benefit on the h1n1 shot (or any flu shot for that matter) is that i don't feel the need to get it ... still - i do think that if people want the shot - they should be able to get it ...
Tuesday, November 24, 2009
Associated Press
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LONDON — The pharmaceutical company GlaxoSmithKline says it has advised medical staff in Canada to not use one batch of swine flu vaccine for fear it may trigger life-threatening allergies.
GlaxoSmithKline spokeswoman Gwenan White said Tuesday the company issued the advice after reports that one batch of the swine flu vaccine might have caused more allergic reactions than normal.
She says the affected batch contains 172,000 doses of the vaccine. She declined to say how many doses had been administered before the advice to stop using them was given.
White says GlaxoSmithKline wrote to Canadian healthcare professionals advising them to stop using the batch on Nov. 18. She says a total of 7.5 million doses of the vaccine have been distributed in Canada.
Comments
there are also hand sanitizers everrywherrre
what i mean by "do" the research is they, the FDA, don't conduct any research or tests themselves, they simply look over the test results that were given to them.
as your article stated
they review the research and tests handed to them by the company trying to get their product approved and the FDA looks it over and makes a risk/benefit assessment
what are you but my reflection? who am i to judge or strike you down?
"I will promise you this, that if we have not gotten our troops out by the time I am president, it is the first thing I will do. I will get our troops home. We will bring an end to this war. You can take that to the bank." - Barack Obama
when you told me 'if you can't beat 'em, join 'em'
i was thinkin 'death before dishonor'
Do the schools have half their regular attedance because kids are getting vaccinated or because they're getting the flu?
As far as schools...eralier in the fall some schools had 1/2-2/3 of their population out sick. Now, not so much. So, at least in my area, the vaccination are not causing kids to become ill in great numbers as someone seems to be suggesting.
Why is that?
why would it be funny? ... is it funny because people are not behaving in a preconceived manner?
Ummm...funny because people arguing for preventative care are criticizing preventative care.
It seems like wanting your cake and eating it too.
both things are open to interpretation in my mind ... some people say drinking milk makes for strong bones and prevents osteoperosis (sp?) while some people don't ... i'm not too sure which people you are referring to in this thread but i know i'm in favour of public health care and i am choosing not to take the shot ...
for me - i like the idea that if i get hit by a car on my bike i'm not gonna have to worry about paying for my hospital visit ... whereas - my risk/benefit on the h1n1 shot (or any flu shot for that matter) is that i don't feel the need to get it ... still - i do think that if people want the shot - they should be able to get it ...
Tuesday, November 24, 2009
Associated Press
* Print
* ShareThis
LONDON — The pharmaceutical company GlaxoSmithKline says it has advised medical staff in Canada to not use one batch of swine flu vaccine for fear it may trigger life-threatening allergies.
GlaxoSmithKline spokeswoman Gwenan White said Tuesday the company issued the advice after reports that one batch of the swine flu vaccine might have caused more allergic reactions than normal.
She says the affected batch contains 172,000 doses of the vaccine. She declined to say how many doses had been administered before the advice to stop using them was given.
White says GlaxoSmithKline wrote to Canadian healthcare professionals advising them to stop using the batch on Nov. 18. She says a total of 7.5 million doses of the vaccine have been distributed in Canada.