USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

[Giuseppe]

USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

FDA NEWS RELEASE

For Immediate Release: July 20, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves Vaccine for 2009-2010 Seasonal Influenza


The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year?s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

?The approval of this year?s seasonal influenza vaccine is an example of the FDA?s important responsibility to assure timely availability of vaccine to help protect the health of the American public,? said Margaret A. Hamburg, M.D., commissioner of food and drugs. ?A new seasonal influenza vaccine each year is a critical tool in protecting public health.?

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA?s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

• an A/Brisbane/59/2007 (H1N1)-like virus
• an A/Brisbane/10/2007 (H3N2)-like virus
• a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical. Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

For more information:FDA Web Page on Influenza Vaccine Safety & Availability: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm
FDA List of Strains Included in the 2009-2010 Influenza Vaccine: http://www.fda.gov/BiologicsBloodVa...st-MarketActivities/LotReleases/ucm162050.htm
U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza Resources for Health Professionals: http://www.cdc.gov/flu/professionals/vaccination/
U.S. Centers for Disease Control and Prevention Web Page with Key Fact About Seasonal Flu Vaccine: http://www.cdc.gov/flu/protect/keyfacts.htm
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<cite cite="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172772.htm">FDA Approves Vaccine for 2009-2010 Seasonal Influenza</cite>

 

[Zac]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

The vaccine for the 2009-2010 seasonal influenza contains:

• an A/Brisbane/59/2007 (H1N1)-like virus
• an A/Brisbane/10/2007 (H3N2)-like virus
• a B/Brisbane/60/2008-like virus

Hmmm, not much change. It's a bit surprising since the 2008-2009 selection was a poor match. (44% as I recall)

The 2008--09 trivalent vaccine virus strains are

A/Brisbane/59/2007 (H1N1)-like
A/Brisbane/10/2007 (H3N2)-like
B/Florida/4/2006-like antigens.

http://www.cdc.gov/flu/professionals/acip/primarychanges.htm

 

[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Given that 90% of influenza in New Zealand is novel H1N1, the seasonal vaccine content may be a moot point, eh?

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[Commonground]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

That's what I'm thinking also, AlaskaDenise.

 

[tropical]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Yes.

Maybe they will somministrate it northern as a simulated pandemic vaccine one when the real vanish ...

It will be a exper. to got a seasonal vacc, and than maybe after few months the pandemic one - maybe it remains only a seasonal (the logic better this cross-reactivity, than nothing ...)

 

[Giuseppe]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Yes.

Maybe they will somministrate it northern as a simulated pandemic one when the real vanish ...

It will be a exper. to got a seasonal vacc, and than maybe after few months the pandemic one - maybe it remains only a seasonal (the logic better this cross-reactivity, than nothing ...)

This could help the mood of people...

This also could be linked to previous animal studies about reduced mortality in 1918-like virus infected animals previuosly vaccinated with trivalent seasonal vaccine containing H1N1 viruses (New Caledonia and Texas)....

 

[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

However, for myself (remembering my HK duck story) in the absence of any vaccine I have a plan. When a bad H1N1 appears to be first arriving in my community, I will seek out a seasonal vaccination, not because of the match, but for the immune system stimulation. I want that VAX about 2-3 weeks prior to exposure.

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[Giuseppe]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

See http://www.flutrackers.com/forum/showthread.php?t=112856

With A. Garcia-Sastre, T. Tumpey and Y. Kawaoka presentation and papers...

 

[Zac]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

That's true enough. I usually don't even bother with flu vaccinations unless at least 2 of the strains were changed.

 

[Zac]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

However, for myself (remembering my HK duck story) in the absence of any vaccine I have a plan. When a bad H1N1 appears to be first arriving in my community, I will seek out a seasonal vaccination, not because of the match, but for the immune system stimulation. I want that VAX about 2-3 weeks prior to exposure.

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Is there any data that suggests that would help? I'm not fond of flushots since they often make me feel mildly feverish and slightly ill for the day.

 

[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

A 2007 discussion of this same subject is here:

http://www.flutrackers.com/forum/showthread.php?p=119287&highlight=H9N2+ducks#post119287

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[Giuseppe]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

However, for myself (remembering my HK duck story) in the absence of any vaccine I have a plan. When a bad H1N1 appears to be first arriving in my community, I will seek out a seasonal vaccination, not because of the match, but for the immune system stimulation. I want that VAX about 2-3 weeks prior to exposure.

.

There may be some true thing in your words, but we need a response by those researchers that earlier investigated 1918-like virus infections reduced mortality in animals vaccinated with H1N1/Texas or H1N1/New Caledonia.

FT is under the eyes of some of these researchers' or their students/assistants.

This is a good point to submit to these valuable Readers...

 

[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

A 2006 discussion of this same subject (with many good links) is here:

http://www.flutrackers.com/forum/showthread.php?t=4350&highlight=cross+reactive+immunity

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[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

My bottom line logic for getting a near-exposure seasonal VAX is not only potential cross-reactivity stimulation, but ..... it won't hurt anything, so why not?

However, it must be timed correctly. I believe that extra stimulation peaks at about 14 to 21 days, then slowly declines, until about 100 days. There is a chart of that buried somewhere here at FT.

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[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

A 2001 paper: http://www.ncbi.nlm.nih.gov/pubmed/11591118?dopt=Abstract

.....The 1997 incidence of avian influenza infections in humans in Hong Kong heightened the need for pandemic preparedness and a search for vaccines and vaccine delivery systems that can confer broad protection. In this report, we demonstrate that the delivery of H1N1 subtype influenza viral antigens as immunostimulating complexes (ISCOM) induces broad cross-protection in mice against challenge with various influenza virus subtypes, including the avian H9 and the H5 strains that were recently responsible for deaths in humans......

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[Zac]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Thanks for the links. This is very interesting reading.

Since the type A strains didn't change for the 2009-2010 flu vaccine, I wonder if it would still provide that up to 100 day benefit for someone who already received the vaccination last year.

 

[Giuseppe]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

see http://www.flutrackers.com/forum/showthread.php?t=112856

with a. Garcia-sastre, t. Tumpey and y. Kawaoka presentation and papers...

are there some reasons to think the above authors' results may have been fabricated or manipulated before publications?

Are there applicable to our pandemic scenario?

Where are people that are thinking about 1918 and current h1n1 similarities?

I greatly appreciate a response.

 

[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

I re-read some of those earlier H9N2 protected H5N1 poultry papers. They think that part or all of the immunity is afforded because of similar internal epitopes. Remember how H9N2 was a donor to H5N1? So that theory wouldn't apply to our case. However, some refer to a general immune system stimulation. One interesting paper relates to the 1976 Ft. Swine flu situation..They speclate that a recent H3N2 VAX may have saved many exposed to Hsw1N1. this may be more applicable to our current situation.

http://www.flu.org.cn/en/article-3874.html

(snipped)

Concerns that influenza A (H3N2) infection or vaccination might stimulate antibody to A/Mayo Clinic were addressed. Four groups were studied to identify persons with >4-fold heterotypic HAI antibody increases to A/Mayo Clinic. None were found in 39 Fort Dix soldiers who received influenza vaccine in February 1976 (group 1), and none were found among 27 hospitalized soldiers from posts other than Fort Dix who had >4-fold rises in complement fixation (CF) antibody to influenza A (group 2) (7). In the third group, >4-fold rises in antibody titers developed in 3 (8%) of 40 soldiers from Fort Dix and elsewhere who had been hospitalized with an A/Victoria isolate (7). In the fourth group, a single serum sample was studied from each of 168 randomly selected Fort Dix basic trainees who had received their annual influenza vaccination 3 to 4 weeks earlier (11). Only 4 (2%) had HAI titers >1:20 to A/Mayo Clinic (11). In similar studies by others, in 0%?6% of persons, heterotypic antibody to influenza A/swine developed after infection with A/Victoria (H3N2) or influenza vaccination (12,13).

(note: "novel virus was named A/New Jersey/76 (Hsw1N1). Initially, HAI serologic studies of Fort Dix populations were performed at WRAIR by using inactivated A/Mayo Clinic/103/74 (Hsw1N1) antigen from CDC (7). The A/Mayo Clinic virus was recovered in 1974 from lung tissue obtained at autopsy from a man with Hodgkin disease who lived on a swine farm (8). "


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[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

My references to a HOng Kong duck should be revised to refer to Hong Kong poultry. see related 2002 article at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=136145#r26

Protective Cross-Reactive Cellular Immunity to Lethal A/Goose/Guangdong/1/96-Like H5N1 Influenza Virus Is Correlated with the Proportion of Pulmonary CD8+ T Cells Expressing Gamma Interferon
Sang Heui Seo,1 Malik Peiris,2 and Robert G. Webster1*

(snipped)

Abstract

A/Goose/Guangdong/1/96-like H5N1 influenza viruses now circulating in southeastern China differ genetically from the H5N1 viruses transmitted to humans in 1997 but were their precursors. Here we show that the currently circulating H9N2 influenza viruses provide chickens with cross-reactive protective immunity against the currently circulating H5N1 influenza viruses and that this protective immunity is closely related to the percentage of pulmonary CD8+ T cells expressing gamma interferon (IFN-γ). In vivo depletion of T-cell subsets showed that the cross-reactive immunity was mediated by T cells bearing CD8+ and T-cell receptor (TCR) α/β and that the Vβ1 subset of TCR α/β T cells had a dominant role in protective immunity. The protective immunity induced by infection with H9N2 virus declined with time, lasting as long as 100 days after immunization. Shedding of A/Goose/Guangdong/1/96-like H5N1 virus by immunized chickens also increased with the passage of time and thus may play a role in the perpetuation and spread of these highly pathogenic H5N1 influenza viruses. Our findings indicate that pulmonary cellular immunity may be very important in protecting na?ve natural hosts against lethal influenza viruses.

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[AlaskaDenise]

Re: USA. FDA Approves Vaccine for 2009-2010 Seasonal Influenza

..........Are there applicable to our pandemic scenario?

Where are people that are thinking about 1918 and current h1n1 similarities?

I greatly appreciate a response.

Is there any recent research that can enlighten us on this subject?

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