Vaccine Zombie video to watch !

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Today we will look at a study about the efficacy and safety of the flu vaccine in infants. The study was published in The Pediatric Infectious Disease Journal in February 2010.

Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study.

Englund JA, Walter E, Black S, Blatter M, Nyberg J, Ruben FL, Decker MD; GRC28 Study Team.

Study Summary- This was a double-blind, randomized, placebo-controlled trial, conducted in 1375 healthy US infants 6 to 12 weeks of age. Subjects received 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone, Sanofi Pasteur; N = 915) or placebo (N = 460) 1 month apart in combination with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following vaccination, and unsolicited adverse events for 28 days. Antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.

Results – No significant differences were seen between TIV and placebo groups for any safety outcome. Fever > or =38 degrees C within 3 days of vaccination was seen in 11.2% versus 11.7% of TIV versus placebo recipients. Serious adverse events within 28 days were reported in 1.9% of TIV and 1.5% of placebo recipients. Antibody responses to childhood vaccines were similar in both groups. Increased influenza-specific antibody responses in TIV recipients compared with placebo recipients were seen against all 3 strains in TIV recipients, with better responses to influenza A strains noted. Reciprocal geometrical mean titer to H1N1, H3N2, and B were 33, 95, and 11 in TIV recipients versus 7, 9, and 5 for placebo recipients.

Conclusion – This study fulfills all the basic requirements for a well designed scientific study. The sample was large (1,375 participants); it was double-blind, randomized and placebo controlled. This study showed that the trivalent, inactivated flu vaccine was just as safe as the placebo and highly more efficient than placebo in inducing antibody response to all three strains of the virus. The authors concluded as such:

TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.

Thomas has started a series on vaccines and disease and I thought it was such a great idea that I would hijack it, kind of.

While Thomas talks about specific vaccines and their impact on certain diseases I thought I would cover some more general topics under the umbrella of vaccines. So let me present my own vaccine mini-series to supplement Thomas’ – Vaccines: how they are made?, how do they work?, and why we can’t rely on therapeutics alone in the fight against disease?

This week we will look at how some of the common ways vaccines are made. This has been a topic of interest to me for a while, ever since I heard someone from the (miss-information spreading, anti-vaccination supporting) Australian Vaccination Network giving a talk at a Vegan festival about the dangers of vaccines. In front of a room full of people this woman proudly proclaimed that the polio vaccine is made in monkey brains and if you let your child take the oral polio vaccine they will be eating monkey brain. I was dragged away before I could ‘politely question’ the woman by my wife, who had declared a science free weekend .

Anyway, the point is that this woman was talking crap. There would be no logic to making the vaccine in monkey brains, how many monkey brains does she think evil scientists can get their hands on? All the monkey heads I get my hands on are used in the construction of two headed monkey slaves. I wouldn’t waste them on vaccine production.^¶

So what are the different types of vaccines and how are they made? There are a number of different types of vaccines and each have been developed for different reasons, to prevent different types of disease and to do specific jobs once inside the body. I’ll talk more about the body’s response next week but for now we can just look at the vaccines.

One of the oldest and most popular vaccines is the ‘killed vaccines’. As is implied the killed vaccines are whole infectious particles that are killed or inactivated in some way so they are no longer infectious but, importantly, still look to the immune system like they would if they were alive. Inactivation can be done using chemicals such as formalin and formaldehyde or can simply be ‘heat-inactivated’ or as I like to think of them – cooked. The early pneumococcal vaccines were cooked and now smallpox and Hepatitis B vaccines can be produced in this way. The inactivated vaccines are great because it is impossible for them to cause disease, they’re dead – so they’re fine.

A variation of the inactivated vaccines are the toxoid vaccines. These vaccines are designed to protect not against the whole micro-organism but against any toxic product it may make. Generally this involves taking the toxin itself and heating it. This works particularly well for protein toxins as they unravel when heated excessively so the protein toxins are rendered useless but even unravelled all the toxin components remain present allowing your immune system to recognise the constituent parts and, with any luck, the normal form of the toxin as well. Tetanus and diphtheria toxins have been used to make toxoid vaccines but snake and spider venom have also been used and are administered to farm animals in some cases.

Attenuated vaccines are a little different because they involve a live infectious disease particle that has been severely weakened. They are often more effective than inactivated vaccines because you can generally introduce the attenuated version via the normal route of infection to maximise the appropriate response. To attenuate an infectious organism the best and most utilised way is to take a human version of the disease and force it to infect something not human. That could be a whole animal like a mouse or a cell line derived from another spices such as Vero cells that were derived from monkey kidneys. If you force the infection and collect the micro-organisms that were successful and re-infect your non-human host number of times (generally 7-8 times) you can end up with a human pathogen that is optimised for infecting a non-human. This gives you immune system a significant advantage in generating an immune response and life-long protection against something that looks like the real thing but doesn’t behave like the real thing.

In some cases using the using the entire infectious agent can be less effective than using only the parts that will be the target of the immune response. Subunit vaccines are generally produced for viruses and are enormously useful as vaccines. Just as the name suggests rather than using a whole dead virus or a weakened version of a live virus the sub-unit vaccines just use a part of them and often that part is the component that will interact with the immune system under normal conditions. When a virus infects a cell it does so to manufacture more copies of itself and its genome. Following manufacture of all the viral elements they must be assembled into new viruses but this is a random and often inefficient process. Often genomes are left out of assembling virus particles leaving an empty shell. This shell can leave the cell and infect a new cell but doesn’t contain a genome so cannot deliver a payload of viral DNA. Researchers noticed this and found that if you could prevent genome entry you could produce virus-like particles that contained all the bits of the virus except for the genome, therefore could be seen by the host’s immune system but were entirely non-infectious! HepB, Human papilloma virus and some flu vaccines are made like this. These vaccine types are effective but as they do not persist in the host often require multiple doses for full activity.

Finally the last major group of vaccines are the conjugate vaccines. Conjugate vaccines contain something you want the immune system to target conjugated or ‘stuck’ to something the immune system will easily recognise. The most obvious example (to me anyway) are the current Pneumococcal vaccines. The outer coat of the bacteria is made of sugars that the immune system doesn’t recognise easily but when stuck to a an inactivated form of the diphtheria toxin the immune system can recognise both and protection against the sugar is maintained.

The vast majority of vaccines these days are made as subunits or conjugates as we move away from giving people whole bacteria or viruses. This is due to cases of re-activation or incomplete killing of vaccine stocks resulting in the very disease the vaccine was designed to protect against. Even still given the amount of vaccinations that occur each year and the proportionally tiny number of adverse reactions it’s easy to see vaccines for the wonderful addition to preventative healthcare that they are.

^¶ Whilst I maintain the woman was wrong there is a connection between monkey brains and polio vaccines and just the faint hint at truth is all that’s needed by the anti-vaccination groups.

In the early 1930’s polio virus was harvested from monkey spinal cords by grinding them up and treating the pulp with formaldehyde which inactivates the virus. After testing the mixture on himself and others in his lab, Maurice Brodie trialled it on a sample of 3000 children. It didn’t work, at all. Not a single person developed immunity to polio and some suffered adverse reactions to the mixture, resulting in it never being used again. That’s it, that’s the polio – monkey brains link.

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References

Buonaguro L, Tornesello ML, & Buonaguro FM (2010). Virus-like particles as particulate vaccines. Current HIV research, 8 (4), 299-309 PMID: 20353398
Graves PM, Deeks JJ, Demicheli V, & Jefferson T (2010). Vaccines for preventing cholera: killed whole cell or other subunit vaccines (injected). Cochrane database of systematic reviews (Online), 8 PMID: 20687062
Dhillon S (2010). DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa): A Review of its Use as Primary and Booster Vaccination. Drugs, 70 (8), 1021-58 PMID: 20481658

Last December, as the Administration terrorized America with the threat of the waning H1N1 “epidemic aka epic-demic, I wrote this piece Swine Flu Vaccine Recall, Short Ships, and Many Questions. At the time, I was really interested how the vaccine and distribution was paid for, but could find no information. Well, well, well… that changed today by sheer accident.

I have a friend on the road who asked me to check into something in Pennsylvania. One of my first tools of choice, that I use, is to examine the Stimulus Watch 2.o site. As I proceeded to the links this morning and those pertaining to Pennsylvania, at the top of the list was

Contract

To supply vaccines for CDC’s adult vaccine contract

$413,955

Swiftwater

PA

0

0

So I just had to click on it and low and behold I found SANOFI PASTEUR INC. and guess what! Sanofi Pasteur Begins Shipping Influenza Vaccine in U.S. for 2010-2011 Season

I really must find out how this newest shipment was paid for, because I just discovered how last year’s shipment was funded, Stimulus dollars in June, (note July is absent) August, and September 2009 by a  bill signed in February 2009 for stimulus and job creation? How did that happen? How is it happening this year?

Sanofi Pasteur Begins Shipping Influenza Vaccine in U.S. for 2010-2011 Season

SWIFTWATER, PA

SANOFI PASTEUR INC.

Total Received: $45,109,874.70 – Visit on the Web

Below you will find all the contracts, grants, and loans received by SANOFI PASTEUR INC. as of October 30, 2009. You can sort by the different table columns. Click on an item for more information and to comment and vote on the item.

Primary Recipient

Type	Description	Amount	City	State	Jobs	Vote
Contract	To supply vaccines for CDC’s adult vaccine contract	$413,955	Swiftwater	PA	0	0
Contract	To supply flu vaccines for CDC’s adult vaccine contract	$1,896,623	Swiftwater	PA	0	0
Contract	To supply pediatric vaccines for CDC’s Vaccine for Children contract.	$10,358,763	Swiftwater	PA	0	-1
Contract	HHSO100200800073I Modification 5 – manufacturing of clinical trial material in support of H1N1 clinical trials for Mix n Match and…	$730,000	Swiftwater	PA	0	0
Contract	The contractor shall furnish all necessary facilities, equipment, materials, and personnel, and shall perform all services necessary to conduct three…	$29,360,000	Swiftwater	PA	31	-1
Contract	To supply flu vaccines for CDC’s VFC vaccine contract	$2,350,534	Swiftwater	PA	0	-1

What Say You America? Was it All About the Money? Where has the Money come from? Where is the Money now? “We the People” are being taking for a last ride via AIR POLAND!

Dedicated to JoAnne, I finally got to use it

*Taken from The Epoch Times. Written by Stephanie Lam & Chowa Choo.

The Finnish National Institute for Health (THL) proposed suspending vaccinations for H1N1 swine flu, due to suspected links to increased narcolepsy in children and adolescents, the body announced this week.

Six cases of narcolepsy, a chronic disorder causing excessive daytime sleepiness and extreme fatigue, have been reported after patients had been receiving the Pandemrix vaccine.

Six cases of narcolepsy is consistent with annual averages, reports THL, but all of these patients were affected after being vaccinated, and there are nine additional cases that have not yet been confirmed.

The precautionary measure will take effect until the actual cause of the current health issue can be established. Preliminary results of the investigation will take several months to be known, says the THL.

“A number of different reasons may be behind the observed rise in the incidence of narcolepsy: A(H1N1) infection, vaccination, a compound effect of infection and vaccination, or some other factor entirely. Infections in general are known to cause narcolepsy,” said a THL press release.

In Sweden, the Medical Products Agency started a similar investigation on Aug. 19 for the same reason. Sweden has bought 18 million doses of the vaccine, sufficient for everyone in the country to have two injections. In Europe, about 30 million people have been vaccinated, and worldwide at least 90 million.

Last winter, 29 million children in the United States were given a seasonal influenza shot that incorporates the swine flu vaccine, but according to Tom Skinner, press officer of Centers for Disease Control and Prevention, narcolepsy associated with the vaccine has not been reported.

According to Marjo Renko, chairwoman of Finland’s national group of experts on vaccines, a substance was identified as possibly cause narcolepsy, but later denied it.

“There is no proof that the increase in narcolepsy would be linked with the vaccines. We do not suspect anything. This is mere speculation,” she said, according to Helsingin Sanomat.

The meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) just updated the 2009 recommendations regarding the use of influenza vaccine for the prevention and control of influenza.  These 2010 influenza recommendations include new and updated information.

The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in fields associated with immunization, who have been selected by the Secretary of HHS to provide advice and guidance to HHS and the CDC on the control of vaccine-preventable diseases. The role of the ACIP is to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products.

Highlights of the 2010 revisions include:

1. Recommendation that annual vaccination be administered to all persons over 6 months of age for the 2010–11 influenza season
2. Recommendation that children aged 6 months–8 years should receive 2 doses of the 2010–11 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010–11 season if they meet the following criteria:
   • Vaccination status is unknown OR
   • Have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009–2010 but received only 1 dose in their first year of vaccination)
   • Children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history
3. Recommendation that vaccines contain the 2010–11 trivalent vaccine virus strains:
   • A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines)
   • A/Perth/16/2009 (H3N2)-like
   • B/Brisbane/60/2008-like antigens be used
4. Information about Fluzone High-Dose, a newly approved vaccine for persons aged ≥65 years
5. Information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Vaccination efforts should begin as soon as the 2010–11 seasonal influenza vaccine is available and continue through the influenza season.

These recommendations also include a summary of safety data for U.S.-licensed influenza vaccines. These recommendations and other information are available at CDC’s influenza website (http://www.cdc.gov/flu); any updates or supplements that might be required during the 2010-2011 influenza season also will be available at this website.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0729a1.htm?s_cid=rr59e0729a1_e

Clinical Infectious Diseases 1 June 2010 V.50  N.11  p.1487–1492

Jonathan A. McCullers, Lee‐Ann Van De Velde, Kim J. Allison, Kristen C. Branum, Richard J. Webby, and Patricia M. Flynn

Department of Infectious Diseases, St Jude Children’s Research Hospital, Memphis, Tennessee

Background

The world is facing a novel H1N1 influenza pandemic. A pandemic scare with a similar influenza virus in 1976 resulted in the vaccination of nearly 45 million persons. We hypothesized that prior receipt of the 1976 “swine flu” vaccine would enhance immune responses to the 2009 novel H1N1 influenza strain.

Methods

A prospective, volunteer sample of employees aged 55 years at a children’s cancer hospital in August 2009 was assessed for antibody responses to the 2009 pandemic H1N1 influenza virus and the 2008–2009 seasonal H1N1 influenza virus.

Results

Antibody responses by hemagglutination‐inhibition assay were high against both the seasonal influenza virus (89.7% had a titer considered seroprotective) and pandemic H1N1 influenza virus (88.8% had a seroprotective titer). These antibodies were effective at neutralizing the seasonal H1N1 influenza virus in 68.1% of participants (titer 40), but only 18.1% had detectable neutralizing titers against the pandemic H1N1 influenza virus. Of 116 participants, 46 (39.7%) received the 1976 “swine flu” vaccine. Receipt of this vaccine significantly enhanced neutralization responses; 8 (17.4%) of 46 vaccine recipients had titers 160, compared with only 3 (4.3%) of 70 who did not receive the vaccine ( by χ2 test).

Conclusions

In this cohort, persons aged > 55 years had evidence of robust immunity to the 2008–2009 seasonal H1N1 influenza virus. These antibodies were cross‐reactive but nonneutralizing against the 2009 pandemic H1N1 influenza strain. Receipt of a vaccine to a related virus significantly enhanced the neutralization capacity of these responses, suggesting homologous vaccination against the 2009 pandemic H1N1 influenza virus would have a similar effect.

abstract

http://www.journals.uchicago.edu/doi/abs/10.1086/652441