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Sinovac: Chinese Vaccine `Protects' With 1 Dose

http://afludiary.blogspot.com/2009/08/sinovac-chinese-vaccine-protects-with-1.html

If they are only going to give one injection, yet getting a good immune response, that means that they have to be using an adjuvant. Here in the US, it was decided not use adjuvants for the swine flu vaccine, at least for now. So any vaccine that will be given out in the US, even if from a foreign source, cannot use adjuvants.

Now, what would your first thought about using the Sinvac product be if you were allowed to do so?

I can guess what many would be thinking.

"This is from China, right?"

With so many to vaccinate, not much time left to do it in, and perhaps less worry about possible side effects, the Chinese chose to go with the adjuvants. We'll know more later if they release the data.

If, as suggested by Sinovac's overnight announcement, reasonable immunity can be created with just one shot, it would greatly expand our capacity to vaccinate large numbers of the public.

Sinovac offered no data with their announcement, and so we have no idea about the dose, whether it was adjuvanted or unadjuvanted, the level of antibody response it elicited, or the age groups of those that showed this response.

In other words, all we have is a broad statement by company, and no data to back it up. Yet.

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US Cuts Doses of Flu Vaccine

http://afludiary.blogspot.com/2009/08/brother-can-you-spare-shot.html

So there won't be much available for the high risk groups, and not a surprise that they will have to prioritize.

It appears that HCW, if you read our little poll (https://allnurses.com/pandemic-flu-forum/would-you-accept-412057.html) won't be using the full amount allocated for them if our poll is anything to go by, and we get vaccinated at our usual robust 40% rate!!

I expect that by the time both doses of the vaccine are available (remember you have to get both for full immunity), many of us will be naturally immunized by the virus anyway...

But, in the back of my mind, I wonder about who the random perfectly healthy victims with a fatal result will be. That these deaths will occur is still likely. They are occurring already even here in the summertime. With more people getting sick in the fall, there will be more deaths in the high risk groups as well.

U.S. health officials on Monday said they have slashed their estimate of how many swine flu vaccine doses will be available for the start of a mass vaccination campaign in the fall.

Citing delays in manufacturing and packaging the vaccines, the Department of Health and Human Services said only 45 million doses of the new H1N1 vaccine would be on hand in mid-October, instead of the 120 million previously forecast.

The revised delivery guidelines would push back a federal government estimate that all those requiring vaccinations be immunized by the first week of December.

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Specializes in ICU,ANTICOAG,ACUTE STROKE,EDU,RESEARCH.

Also interesting to look at the current clinical trials for the vaccines

http://clinicaltrials.gov/ct2/results?term=H1N1

Seems they are all phase 2 studies-so they are measuring safety and efficacy rtaher than just efficacy-so little safety data available yet

Some are adult studies some paeds.

Some are adju

Some are placebo v vaccination

Some are looking at 2 different doses

Some have an upper cut off age of 65yrs (most)

None of the trials are due to finish before Spring next year

The exclusion criteria are fairly similar (if not completely the same) in all the studies

Some that are particularly interesting are

1.Pregnancy (have to avoid pregnancy for so long after shots)

2.Certain psychiatric illnesses of medications

3.Immunosuppresion (including steroid inhalers for the paed studies)

4.History of GB.

So if these groups of people are excluded from the studies,even if they did an interim safety analysis,there will not be any data available for these groups of people.

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Influenza virus-like particle vaccine

http://www.virology.ws/2009/08/19/influenza-virus-like-particle-vaccine/

A new type of vaccine against influenza, made with virus-like particles, has been shown to protect ferrets from infection with the 2009 H1N1 swine-origin strain. What is a virus-like particle, and how is it produced?

If you have been taking influenza 101, you know that new virus particles are produced in infected cells by budding. During this process, the membrane bulges from the cell and is eventually pinched off to form a free particle. These virus particles contain the viral RNA segments, and an assortment of viral proteins including PA, PB1, PB2, NP, M1, M2, HA, and NA. But not all of those viral proteins are needed to produce an influenza virus particle. When only the viral HA, NA, and M1 proteins are synthesized in cells, particles are released from cells that look very much like influenza virions (illustrated). These are called 'virus-like particles' because they resemble influenza viruses, but lack the viral genome and many viral proteins.

Influenza virus-like particles are not infectious, but they are immunogenic: when injected into animals, they induce the production of anti-viral antibodies that can block infection. In one study, virus-like particles were produced in cultured insect cells by using an insect virus vector - a baculovirus - to deliver genes encoding the influenza HA, NA, and M1 proteins. Mice inoculated with these virus-like particles were protected after challenge with infectious virus. More recently, mice vaccinated with virus-like particles produced with proteins from an H5N1 avian strain were protected against challenge with lethal H5N1 viruses.

These findings suggest that virus-like particles could be used in humans to protect against influenza infection. They offer a number of advantages over the current influenza virus vaccines, most of which are prepared by growing virus in embryonated chicken eggs. Viral infectivity is destroyed with formalin, and the virions are then disrupted with detergents. Virus-like particle vaccines would not require these treatments, and would be available to individuals with egg allergies. Some influenza virus vaccines are produced in cell culture, but these are also treated to eliminate infectivity.

Another important advantage of the virus-like particle vaccine is that it can be produced relatively rapidly: within weeks, compared to months for egg-produced vaccines. This property would be especially useful when new pandemic strains emerge. For example, the swine-origin H1N1 influenza virus emerged in the spring of 2009, and vaccine manufacturers are scrambling to have a product ready for the fall.

Because an influenza virus-like particle vaccine is a new type of vaccine, many years of testing in animals and in humans will be required before it can be used. Some of the questions that must be addressed include the safety of the vaccine in humans, whether the anti-viral antibody repertoire induced by the vaccine is sufficiently broad, and of course whether immunization confers efficient protection against challenge in the majority of recipients.

I am particularly curious about how an influenza virus-like particle vaccine would compare with the infectious, attenuated influenza vaccine, Flumist. This intranasally-administered vaccine mimics a natural infection and has been shown to be more effective in preventing influenza than inactivated vaccine. While virus-like particle vaccines are an attractive option, they are not infectious and therefore might not induce the same antibody repertoire as would an infectious virus. A disadvantage of Flumist is that it is produced in eggs. If influenza virus-like particles prove safe and efficacious in humans, they could replace the egg-grown, inactivated vaccines.

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No Side Effects So Far in Trial of Swine Flu Shot

http://www.nytimes.com/2009/08/22/us/22flu.html?_r=1

There have been no serious side effects from the first set of injections of the new swine flu vaccine, federal health officials said Friday in predicting that nearly 200 million doses could be produced by year's end.

Clinical trials in adults began on Aug. 7, and those in children on Wednesday.

"There are no red flags regarding safety," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing the trials.

Because the only side effects in adults were sore arms, which are typical of any flu shot, trials on children were able to begin, and those in pregnant women are expected to begin early next month, Dr. Fauci said in a telephone news conference with officials from the Food and Drug Administration and the Centers for Disease Control and Prevention.

The vaccine will be tested in about 4,500 people. That is far too few to pick up subtle side effects, but the virus strain in the vaccine is close enough to one strain in seasonal shots so that side effects are expected to be similar.

The trials will help officials decide whether to recommend one dose or two. Even with seasonal flu shots, young children who have never had the flu sometimes need two doses to get a "take"-vaccinologist jargon for a protective immune response.

Unless the virus changes, health officials do not expect to recommend mixing in adjuvants. Adjuvants, usually oil-water emulsions or aluminum salts, boost the immune system but also often heighten unpleasant side effects.

(hat tip pfi/pixie)

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I was at a conference today about H1N1. They gave us a list of global manufacturers of the vaccine.

Glaxo SmithKline (UK) and Novartis (Switzerland) will have MF59, the novel flu vaccine adjuvant in them. together they make up 50% of the H1N1 vaccines available globally.

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Thanks for telling us this. It is very interesting, katnip. Did they give you any links to info online that would indicate which of any of these adjuvated vaccines will be used in the US?

So far, I have only heard that adjuvants have not been approved for use in flu vaccines here, so if there has been a change in policy, we need to know this. It would be big news. I have only heard that the US purchased adjuvants for the stockpile for possible future use.

What do we know so far about which companies are for sure going to supply the US, and what kind of vaccines are they sending?

Can anyone contribute articles on vaccines that are definitely going to be used here? We should make a list of what they are going to be using on the US population. This could be important information to know so that everyone can make the best choice of what may be available if deciding to be vaccinated ourselves or for our family members.

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Specializes in ICU,ANTICOAG,ACUTE STROKE,EDU,RESEARCH.

The vaccine will be tested in about 4,500 people. That is far too few to pick up subtle side effects, but the virus strain in the vaccine is close enough to one strain in seasonal shots so that side effects are expected to be similar.

Phase IV clinical trials often include thousands of people.It can take 10 years of clinical trials to get a drug license.

I like the word "subtle".Assume that might mean longer term, but they have already started giving it to childen.

I am wondering if the vaccines can be given a license after phase II studies only,

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http://www.nytimes.com/2009/08/22/us/22flu.html?_r=2

I can understand your concern, misswoosie. Apparently there were 3 different US agencies represented at the telephone news conference. In retrospect, this actually is not a very informative article at all. They fail to identify exactly which manufacturer's vaccine they are talking about, for surely not all the vaccines will generate the same response. This press release was more of a feel good kind of conference which did not give precise information out.

Personally, I would like to hear more about all of the vaccines that they are planning on using here in the US.

Which vax are they are going to use in your country, misswoosie? Will it contain an adjuvant? Which agencies will oversee this in the UK?

“There are no red flags regarding safety,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing the trials.

Because the only side effects in adults were sore arms, which are typical of any flu shot, trials on children were able to begin, and those in pregnant women are expected to begin early next month, Dr. Fauci said in a telephone news conference with officials from the Food and Drug Administration and the Centers for Disease Control and Prevention.

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Specializes in Rehab, Sub Acute.

First, We as Nurses have the responsibility to be our Patients Advocates! And it is time that we all stand up for our Patients and Ourselves!

The Swine Flu Vaccination was patented in 2003 by Novartis. The swine flu virus was described as being "Man-Made" including spliced DNA from the bird flu viruses, human flu viruses, and several diffrent swine flu viruses. And most recently 8/13/09 Novartis has launched a legal action against Glaxo Smith Kline claiming that it is infringing one of its patents. That makes me want to ask questions... will I be refusing any and all flu vaccinations this year, and I question if I should administer Flu vaccinations to my Patients.

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First, We as Nurses have the responsibility to be our Patients Advocates! And it is time that we all stand up for our Patients and Ourselves!

The Swine Flu Vaccination was patented in 2003 by Novartis.

The Novatis vaccine of 2003 cannot be the same vaccine that Novartis will use now, NurseforChange because the target is a different virus entirely.

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Thanks for telling us this. It is very interesting, katnip. Did they give you any links to info online that would indicate which of any of these adjuvated vaccines will be used in the US?

So far, I have only heard that adjuvants have not been approved for use in flu vaccines here, so if there has been a change in policy, we need to know this. It would be big news. I have only heard that the US purchased adjuvants for the stockpile for possible future use.

What do we know so far about which companies are for sure going to supply the US, and what kind of vaccines are they sending?

Can anyone contribute articles on vaccines that are definitely going to be used here? We should make a list of what they are going to be using on the US population. This could be important information to know so that everyone can make the best choice of what may be available if deciding to be vaccinated ourselves or for our family members.

They did not specify. I'm not sure they know exactly yet since it will be the federal government that buys and distrbutes the vaccine.

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