Date: March 1, 2012
Abstract: To date, all currently available, licensed influenza vaccines on the market are trivalent, or contain three strains of the influenza virus.
That is until now. In a press release Wednesday, Maryland biological products manufacturer, MedImmune, announced the US Food and Drug Administration (FDA) approval of the first quadrivalent vaccine to protect against seasonal influenza.
The vaccine, FLUMIST Quadrivalent, intranasal, offers broader coverage against the seasonal flu by incorporating a second influenza B strain.
The US Centers for Disease Control and Prevention (CDC) said in the past decade, two different strains of influenza B have circulated (B/Yamagata and B/Victoria) with half the years the flu vaccine did not contain the predominant strain.
This comes a day after the FDA's Vaccines and Related Biological Products advisory committee voted on which strains to include in the trivalent flu vaccines for the 2012-2013 season.
They voted nearly unanimously to replace the current Brisbane/Victoria strain with the Wisconsin/Yamagata strain.
The World Health Organization (WHO) recommended including the California and Victoria influenza A strains and the Wisconsin/Yamagata influenza B strain in vaccines for the Northern Hemisphere for the 2012-2013 season.
However, as MedImmune’s executive vice president of Research and
Development, Bahija Jallal said, “This is the first quadrivalent influenza
vaccine approved and MedImmune is pleased to be able to take the next steps in
making this product available to the public. We believe that the inclusion of
an additional B strain in an annual influenza vaccine could provide a direct
health benefit to individual vaccine recipients in the event that the correct B
lineage either is not selected for inclusion in a trivalent vaccine, or if both
lineages co-circulate” (Examiner, 2012).
Title: Vaccine Access Act Passes Florida Senate
Date: March 7, 2012
Abstract: The State of Florida is one-step closer to being the 46th state that allows pharmacists to administer shingles and pneumonia vaccination to adults, in addition to flu shots.
The bill, the Vaccine Access Act (HB 509/SB 850) passed the Florida Senate Wednesday with a vote of 36-1.
Last month, the bill passed the Florida House of Representatives unanimously with a vote of 118-0.
Rep. Ana Rivas Logan (R-Miami) sponsored the House bill, while Senator Steve Oelrich (R-Gainesville) sponsored the Senate bill.
Now the bill will be sent to Governor Rick Scott, hopefully to be signed into law.
The passing of the Vaccine Access Act has drawn praise by some consumer and pharmacy groups.
Bill Mincy, BPharm, national board chair of Pharmacy Choice & Access Now (PCAN) commended the Senate saying, “This is a great day for Floridians and demonstrates the desire for patients to have improved access to the vaccines that are critical to their health and well-being. This measure is a way to keep health care costs down -- helping patients to receive preventative immunizations rather than expensive treatments.”
Michael Jackson, executive vice president and CEO of the Florida
Pharmacy Association and a member of PCAN said, “It’s not every session the
legislature is faced with an issue that receives such wide support, but the
Vaccine Access Act is truly commonsense policy and significantly impacts the
lives of Floridians in a positive way -- even saving their lives. We encourage
Governor Scott to see this Act as a cost-saving and life-saving measure that
Floridians can immediately experience the benefits of” (Examiner, 2012).
Title: Foot-And-Mouth Disease Vaccine Developed In US
Date: April 26, 2012
Abstract: With the US livestock industry on alert after a diagnosis of "mad cow" disease in California, the BBC has gained rare access to a high-security compound where a vaccine for another deadly animal virus is close to completion.
Hijacked planes, dirty bombs and cyber attacks are all terror threats the US takes very seriously.
But there is another that many Americans may not have considered - foot-and-mouth disease.
The illness is one of the world's most contagious animal viruses. Although it does not infect humans, an outbreak in the US could cost the economy more than $50bn (£31bn), experts estimate.
To avert such a calamity, scientists working for the US government have spent several years developing a foot-and-mouth vaccine. It is expected to be licensed for use in the next few months.
"This is probably one of the most important innovations in the last 60 years in foot-and-mouth disease," says Dr Luis Rodriguez, research leader of the foreign animal disease research unit at the Plum Island Animal Disease Center, where the vaccine has been developed under top security.
"FMD is one of the largest burdens on animal health and production around the world. We pay attention to it when it gets into non-endemic countries like the UK - and if it ever came into the US it would be big news.
"But FMD is a burden every day on the lives of millions people around the world."
Foot-and-mouth causes havoc because it spreads so quickly. It infects cloven-hoofed animals such as cows, pigs, sheep and goats. Infected livestock have to be quarantined and are usually killed. Trade involving meat, dairy and other animal products comes to a standstill.
Vaccines already exist but are of limited use because veterinarians cannot distinguish vaccinated animals from infected animals - both test positive for foot-and-mouth.
That makes it difficult for a country to assure jittery importing nations its animals are free from the disease.
The new vaccine will come with an antibody test that will enable regulators to tell the difference, the researchers say.
And it will also be safe to manufacture in the US because it does not use the whole live virus and cannot replicate, says Dr Larry Barrett, director of Plum Island, a US Department of Homeland Security installation.
"In the US, you can only work on FMD in an island environment, which is why we came here 60 years ago," he says. "They wouldn't allow us on the mainland."
A government-operated ferry is the only way to reach the facility, north of New York's Long Island and just off the coast of Connecticut. No food or drink is allowed off the island to reduce the risk the virus will escape onto the mainland.
The vaccine works by triggering an immune response. A part of the foot-and-mouth virus is placed in a harmless vector - in this case a defective human virus.
The vaccine is then injected into the animal, providing it with the relevant genetic information its immune system needs to fight the foot-and-mouth virus.
"The animal actually makes the vaccine inside its body by producing the FMD protein necessary to create an immune response," says Dr Rodriguez.
"It's a very good innovation - the most effective way to date and very promising technology. I think it's going to revolutionise the way we look at FMD vaccines around the world today."
Research into new vaccines is also underway at the Institute for Animal Health (IAH) in the UK. In 2001 Britain was hit by a severe foot-and-mouth disease outbreak that devastated the farming and tourism industries.
More than 10 million sheep, cows and pigs were slaughtered in an attempt to contain the outbreak. Images of burning carcasses became the hallmark of the crisis.
"The British government has funded this research so that we will have the tools available to support a 'vaccinate to live' policy should we have another outbreak," says Dr Bryan Charleston, head of the livestock viral diseases program at the IAH.
That goal is still some years away, he says, but new approaches and scientific advances are giving cause for optimism.
The foot-and-mouth virus is a genome surrounded by a coat of proteins. The new vaccines use only the proteins - not the live genome part of the virus - which is why they are safe to produce, the scientists say.
Dr Charleston's British team is developing a vaccine that is produced in insect cells instead of a defective virus. Like the vaccine developed at Plum Island, it is extremely stable and can be deployed rapidly to stem an outbreak, he says.
"We have done the same sort of thing as scientists at Plum Island," he says.
"We just got there by a different route."
He hopes the vaccine will offer a longer lasting immunity to foot-and-mouth that will make it suitable for use in countries where the disease is endemic.
"In some cases current vaccines are only effective for three to four months which means livestock need to be vaccinated three or four times a year. The cost of gathering the animals alone is significant - it's just not practical," he says.
Only one major animal disease has been successfully eradicated so far - rinderpest - but scientists hope their work will one lead to the elimination of foot-and-mouth disease.
The last outbreak foot-and-mouth in the US occurred in 1929 and the biggest risk of the disease entering the country today comes mainly from infected animal imports.
There have been more than half a dozen high alerts already this year when samples from animals thought to be infected were flown by jet and helicopter to Plum Island for testing. All the cases turned out to be false alarms (BBC, 2012).
Title: Soligenix To Collaborate With IDRI On Biodefense Vaccines
Date: June 28, 2012
Abstract: Soligenix, Inc., a development stage biopharmaceutical company, announced a collaboration on Wednesday with the Seattle-based Infectious Disease Research Institute to develop biodefense vaccines using IDRI’s synthetic adjuvants and Soligenix’s ThermoVax platform.
The vaccines, which will also use Soligenix’s proprietary subunit proteins, may result in vaccines with characteristics for the rapid onset of protective immunity and long-term stability that could be stockpiled for use in an emergency. The first objective of the collaboration will be the development of an anthrax vaccine.
“IDRI is enthusiastic about working with Soligenix to support their efforts in developing their anthrax and ricin vaccine candidates, and are highly confident that IDRI’s adjuvant technology can help build effective vaccines,” Darrick Carter, IDRI’s vice president of adjuvant technology, said. “These new candidate vaccines could be the critical solution in providing protection to people in the event there is a bioterror threat from the release of anthrax or ricin toxins.”
The anthrax vaccine will combine IDRI’s adjuvant compounds for generating high titer neutralizing antibodies to anthrax toxin with Soligenix’s second generation dominant negative inhibitor subunit protein anthrax vaccine candidate called VeloThrax. The companies will also collaborate on a ricin vaccine.
“We are very pleased to be able to enter into a partnership of this type with IDRI,” Christopher J. Schaber, the president and CEO of Soligenix, said. “IDRI possesses novel R&D, manufacturing and technical expertise in the field of adjuvants. We believe that with the addition of IDRI’s potent adjuvants to our hyperimmunogenic anthrax and ricin toxin vaccines, we will have the potential to develop highly competitive biodefense vaccines that can address the exact needs of the US government with regard to rapid onset immunity with just one or two doses. As with any biodefense program, our goal is to have VeloThrax and RiVax stockpiled by the U.S. government in its strategic national stockpile.”
The initial research of the collaboration will be conducted under
Soligenix’s existing $9.4 million grant from the National Institute of Allergy
and Infectious Disease (BioPrepWatch, 2012).
Title: Homeland Security Develops Vaccine For Foot-And-Mouth
Date: July 6, 2012
Abstract: The Department of Homeland Security announced this week that it has developed the first vaccine for foot-and-mouth disease that can be licensed and manufactured in the United States.
The vaccine could be used against the infectious animal disease in case of an outbreak or attack. The vaccine is effective against just one strain of the virus, but vaccines against other strains are being developed, the Los Angeles Times reports.
“This is the biggest news in (foot-and-mouth disease) research in the last 50 years,” Lawrence Barrett, the director of the Plum Island Animal Disease Center on Long Island, N.Y., said, according to the Los Angeles Times.
Symptoms of foot-and-mouth disease include blisters on the feet and mouth, drooling, fever, loss of appetite and lameness. Animal herds that have become infected with the disease are typically destroyed.
The virus can be spread by bodily secretions, breath, the ground and can be transferred long distances by wind. While the United States has been free of the disease since 1929, Britain had an outbreak of foot-and-mouth in 2001 requiring the culling of 10 million cows. An outbreak in the United States could cost more than $50 billion.Vaccines are available against the virus but contain a live virus and thus cannot be legally manufactured in the United States. The new vaccine contains a coat of proteins that produces an immune response but does not contain genetic material of the disease. The DHS worked with Antelope Valley Biologics and GenVec Inc. to manufacture and license the vaccine (BioPrepWatch, 2012).
Title: Scientists See AIDS Vaccine Within Reach After Decades
Date: July 16, 2012
Abstract: At an ill-fated press conference in 1984, U.S. Health and Human Services Secretary Margaret Heckler boldly predicted an effective AIDS vaccine would be available within just two years.
But a string of failed attempts - punctuated by a 2007 trial in which a Merck vaccine appeared to make people more vulnerable to infection, not less - cast a shadow over AIDS vaccine research that has taken years to dispel.
A 2009 clinical trial in Thailand was the first to show it was possible to prevent HIV infection in humans. Since then, discoveries have pointed to even more powerful vaccines using HIV-fighting antibodies. Now scientists believe a licensed vaccine is within reach.
"We know the face of the enemy," said Dr. Barton Haynes, of Duke University in Durham, North Carolina, and recent director of the Center for HIV AIDS Vaccine Immunology (CHAVI). The research consortium was funded by the National Institute of Allergy and Infectious Diseases (NIAID), founded in 2005 by the National Institutes of Health to identify and overcome roadblocks in the design of vaccines for the human immunodeficiency virus, which causes AIDS. NIAID's funding of CHAVI ended in June.
Unlike many viruses behind infectious disease, HIV is a moving target, constantly spitting out slightly different versions of itself, with different strains affecting different populations around the world. The virus is especially pernicious since it attacks the immune system, the very mechanism the body needs to fight back.
"The virus is far more crafty than we ever thought," said Haynes, who will outline progress in vaccine research at the International AIDS Society's 2012 conference being held in Washington from July 22-27.
First Sign of Hope
Thanks to drugs that can control the virus for decades, AIDS is no longer a death sentence. New infections have fallen by 21 percent since the peak of the pandemic in 1997 and advances in prevention - through voluntary circumcision programs, prevention of mother-to-child transmission and early treatment - promise to cut that rate even more.
Still, as many as 34 million people are infected with HIV worldwide. And with 2.7 million new infections in 2010 alone, experts say a vaccine is still the best hope for eradicating AIDS.
Teams have been working on a vaccine for nearly three decades, but it wasn't until RV144, the 2009 clinical trial involving more than 16,000 adults in Thailand, that researchers achieved any hint of success.
The test of a combination of two vaccines followed several big failures, including the stunning news that Merck's vaccine may have increased the risk of infection among men who were both uncircumcised and had prior exposure to the virus used in the vaccine.
"It had an extremely chilling effect on the whole field," said Colonel Nelson Michael, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, which led the RV144 trial.
The Thai study tested Sanofi's ALVAC, a weakened canary pox virus used to sneak three HIV genes into the body, and AIDSVAX, a vaccine originally made by Roche Holding's Genentech that carried an HIV surface protein.
Both vaccines had poor showings in individual trials. Researchers were so convinced the Thai trial would fail that 22 scientists wrote an editorial in Science calling it a waste of money.
Then came the shocker. Results of the study published in 2009 showed the vaccine combination cut HIV infections by 31.2 percent. According to Michael and many other experts, the result was not big enough to be considered effective, but its impact on researchers was huge, says Wayne Koff, chief scientific officer of the International AIDS Vaccine Initiative (IAVI) based in New York.
An extensive analysis of the Thai trial published this year in the New England Journal of Medicine offered clues about why some volunteers responded.
The study, led by Haynes, scientists at Walter Reed and 25 other institutions, found men and women who were vaccinated made antibodies to a specific region of the virus's outer coat, suggesting this region provides an important vaccine target.
Preparations are under way for a follow-up trial testing beefed-up versions of the vaccines among heterosexuals in South Africa and men who have sex with men in Thailand.
Once again, the trial will use a Sanofi vaccine, but instead of AIDSVAX, researchers will use a different vaccine candidate with a boosting agent from Novartis.
Michael said it has been a major effort to secure new research partners and funding, including support from host countries, as well as to persuade rivals Novartis and Sanofi to work together. The teams still need to retool the vaccines to work in South Africa, where the strain of HIV is different.
"We're really working as fast as we can," said Michael, who expects large-scale effectiveness studies to start in 2016.
The hope is to have at least 50 percent effectiveness, a level that mathematical modelers say could have a major impact on the epidemic. Michael thinks this might be the pathway for getting the first HIV vaccine licensed, possibly by 2019.
Vaccine experts are equally excited about a vaccine that Michael's team is developing with Harvard University and Johnson & Johnson's Crucell unit, which uses weakened versions of a common cold virus and a smallpox virus.
A study published in February showed this vaccine protected monkeys from a virulent strain of HIV. Animals that did become infected after repeated exposure also had low levels of virus in their blood. Safety studies in human patients are just starting, with large-scale efficacy studies slated for 2016.
The current crop of vaccines is largely designed to train immune system cells known as T-cells to recognize and kill cells already infected with HIV. While these trials progress, scientists are working on even more advanced vaccines that activate powerful antibodies to prevent HIV from infecting cells in the first place. Both would be administered before a person becomes exposed to the virus.
Most modern vaccines use this antibody approach, but HIV's extreme skill at mutating makes it difficult for specifically targeted antibodies to identify and neutralize the virus.
Teams led by Dr. Dennis Burton of the Scripps Research Institute in La Jolla, California, Dr. Michel Nussenzweig at Rockefeller University in New York, Dr. Gary Nabel of NIAID's Vaccine Research Center, Haynes at Duke and others have focused on rare antibodies made by 10 to 20 percent of people with HIV that can neutralize a broad array of strains.
Researchers think a vaccine that can coax the body into making these antibodies before HIV exposure would offer a powerful foil to many forms of the virus.
Such antibodies seek out and latch on to regions of the virus that are highly "conserved," meaning they are so critical to the virus that they appear in nearly every HIV strain. By attaching to the virus they make it incapable of infecting other cells.
Until 2009, scientists had identified only a few broadly neutralizing antibodies, but in the past few years teams have found dozens.
So far, scientists have isolated the antibodies, identified what part of HIV they target and even know the exact shape they make, Koff said. Researchers are now using this information to design vaccines that prompt the immune system to make them.
"We're not there yet," Nabel said.
NIAID this month said it will spend up to $186 million over the next seven years to fund the Centers for HIV/AIDS Vaccine Immunology & Immunogen Discovery. The new consortium is focused on making vaccines that induce these protective antibodies, with major grants going to Duke and Scripps.
Nabel said no vaccine being tested today "is likely to hit it out of the park," but many researchers do feel advances in broadly neutralizing antibodies are key to developing a highly successful HIV vaccine.
"It's really a new day when we start to think about where we are with AIDS vaccines," Nabel said (MSNBC, 2012).
Title: Needle-Free Vaccines: How About A Patch Instead?
Date: August 20, 2012
Abstract: Every parent dreads it — holding the baby still while a nurse or technician pushes a needle into the tender flesh of a plump little thigh. The screams are bad enough — add the guilt at knowingly inflicting pain, even with the knowledge that a moment of discomfort is warding off death or weeks of illness.
But what if there was another way? What if a little clear patch arrived by mail, one that could be stuck onto the child’s back and then would dissolve painlessly? Baby’s protected, no one cries and everyone is saved the time and expense of an office visit. Several labs are working to make it happen.
Not only would it ease distress, but Dr. Erin Giudice, a pediatrician at the University of Maryland School of Medicine, thinks it might help fight a growing resistance to vaccination.
“Obviously, for little kids vaccination is very scary and we come at them with a big needle every time they need a vaccine,” Giudice said in a telephone interview.
It's common sense that sitting in front of computer and TV screens is making people fatter. A study out this week puts some precise numbers on it, though — and finds a surprisingly steady pattern across rich and poor countries.
“Having been around parents before and after their children receive multiple needle-based vaccines at the same time, I just can’t imagine that some proportion of why some families decide not to vaccinate ... might have something to do with that we are giving some of these vaccines by a needle,” Giudice says.
Researchers for the government, for universities and at drug companies are all working to make this happen. Already a few needle-free alternatives exist — FluMist nasal spray, which vaccinates against flu with a squirt up the nose, is one. There are oral vaccines for cholera, typhoid and rotavirus.
The earliest vaccines were needle-free. Polio vaccine was once delivered orally — sometimes even on a sugar cube. And from ancient times, people inoculated one another against smallpox by scratching the skin and applying the scab from an infected person, or wiping a bit of cloth against a smallpox pustule and putting it into the nose. But these methods both only worked because they used a live virus – and they often infected people with the very disease they were meant to prevent.
New technologies may make it easier to design needle-free vaccines. One group got the go-ahead from the Food and Drug Administration last week to start testing a needle-free vaccine in people.
The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research group, has teamed up with a company called Medicago that works on vaccines using virus-like particles — little pieces of virus that can’t cause disease but that stimulate the immune system the way a live virus could. It's delivered via a device made by Israeli company NanoPass using what are called microneedles.
Dr. Steven Reed, founder and president of IDRI, says it doesn't hurt and he thinks it will work better than standard, needle-delivered vaccines. He tried it himself.
“You just feel a little pressure — nothing else,” Reed says. The tiny device is covered with sharp little blades that scratch the skin. “It is incredibly small. You can’t even see it.” Reed says. It penetrates the first layer of skin, delivering the vaccine formula itself to immune cells called dendritic cells, which then pass it around the whole body to stimulate protection.
It’s delivered with a needle-free syringe, and Reed believes it would be easy for people to administer it themselves, much like people with diabetes can inject themselves with insulin.
IDRI’s vaccine is designed to protect against H5N1 avian influenza — the so-called bird flu that’s been cooking in Asia, Africa, Europe and the Middle East since 2003 and that many scientists fear could mutate to cause a deadly pandemic in people.
Besides being painless and perhaps something that could be mailed to people, the vaccine should eventually be cheaper and easier to make than current flu vaccines, which must be incubated in eggs and take months to produce. “Our main motivation, frankly, was to get superior efficacy by targeting the dendritic cells,” Reed says. It’s grown in tobacco plants and uses a booster called an adjuvant, which makes a little vaccine go a long way.
"Our idea is to ultimately produce a one-dose vaccine that you could give yourself – imagine a flu vaccine that you can easily administer using a simple, painless microneedle device arriving in your mailbox,” said IDRI’s Darrick Carter.
A similar approach has been developed at Georgia Tech, but it does away with the syringe. The microneedles are embedded in a patch that can be stuck on the skin until it dissolves. It’s being tested against flu and polio.
“The early studies they have that are published give us an indication that it might result in a better response in a shorter amount of time than some of the current vaccines,” says Martin Crumrine, a biodefense specialist at the National Institute for Allergy and Infectious Diseases, part of the National Institutes of Health, which is paying for many of the studies.
In the case of a swiftly moving pandemic or a biological attack, that could be very important. It took months to make and roll out vaccine against H1N1 swine flu when it first broke out in 2009 and thousands of people died during the delay. While in the end H1N1 did not kill more people than annual seasonal flu does, the victims tended to be children and young adults rather than the elderly who are the most likely to die from flu.
NIH is also checking out an oral vaccine against anthrax. Made by PaxVax Inc. of San Diego, it’s given in a capsule – something that, if it works, would be a big improvement on the five injections that military personnel must now get to protect them against anthrax. Anthrax is considered one of the most likely biological weapons – it killed five people in 2001 when someone sent anthrax-laced letters to Congress and media companies.
Needle-free formulations may not only make patients happier, but they may be more stable and thus cheaper and easier to deliver. Most current vaccines must be refrigerated – a real problem for agencies trying to ship them, especially in hot regions and the developing world. “It’s much easier to give a tablet or two than it is to assemble people to give them injections,” says Crumrine.
Not all would be painless. “We are looking at a dengue fever vaccine that can be delivered using a device that you put on the skin surface, press a button, and it uses a small compressed air charge to put the vaccine into the skin,” Crumrine said. Does it hurt? “Probably,” he said.
A more experimental approach would use an electrical charge to make DNA from a virus or bacteria go right through the skin. Called electroporation, it’s being tested against West Nile virus, among other infections, Crumrine says.
NIH scientists are also working on a nasal vaccine, akin to FluMist, that can protect babies against respiratory syncytial virus (RSV). Using a nasal spray can stimulate immune cells right in the sinuses, throat, and lungs as well as throughout the body. RSV infects nearly every child by age, puts as many as 120,000 U.S. children into the hospital every year and globally, it kills 160,000 young children a year.
Other approaches in the works include a dry powder influenza vaccine being developed by Nanotherapeutics that can be inhaled, to protect against a very common stomach bug called norovirus. It’s grown in tobacco plants, like IDRI’s flu vaccine.
Why is it taking so long? Vaccines are usually given to healthy people. amd so they must be much safer than drugs used to treat disease. They're also tricky to make -- a small Maryland company called Iomai spent years testing a vaccine administered using a sandpaper-like device, only to have it fail at the last stages of testing last year. The parent company in Austria shut down most of the operation.
But Giudice would welcome any new approach that got more children immunized. "People are no longer taking it at face value that, yes, I should vaccinate my children," she says."All the evidence we have that is backed up by science shows that it is way, way safer to vaccinate your children than not to vaccinate your children. I feel that anything we can do to make it easier for these parents is helpful” (MSNBC, 2012).
Title: From The Flu Shot To The Shingles Vaccine, Walmart To Offer 10
Date: August 23, 2012
Abstract: Starting Monday, August 27, the world’s largest retailer will be taking another “shot” at offering affordable health care by making available 10 common vaccines against infectious diseases at 2,700 of its stores.
According to a Walmart press release Thursday, the retailer chain will team up with Mollen Immunization Clinics to offer ten CDC-recommended immunizations- Flu (influenza), Pneumonia (pneumococcal), Hepatitis A, Hepatitis B, Chickenpox (varicella), HPV (human papilloma virus), MMR (measles, mumps, rubella), Meningitis (meningococcal), Shingles (herpes zoster) and tetanus,diphtheria and whooping cough (pertussis) (Tdap).
Being the visionary company that it is, Walmart will use registered nurses to administer in-store vaccinations across all store locations, making them the first national retailer to do so.
The move is Walmart’s effort to expand its presence in the multi-billion
dollar health care market.
Previously, in 2006, the retailer had great success with a $4 generic-drug program.
John Agwunobi, M.D., president of Walmart U.S. Health and Wellness said, “According to the Centers for Disease Control and Prevention, many adults are not up-to-date with recommended life-saving immunizations. Vaccinations may not be top-of-mind while the weather is still warm, but they are a critical part of public health, especially in light of recent outbreaks of whooping cough and shingles.
We are making it easy and affordable for our customers to receive their vaccinations – while on their normal shopping trips they can simply stop by immunization events, which will accept thousands of insurance plans and offer low price options for our cash paying customers.”
This year’s flu shot protects
against the H1N1, H3N2 and influenza B virus strains. Flu shots at Walmart are available for $25 (Examiner, 2012).
Title: West Nile Virus Vaccine In Development
Date: September 5, 2012
Source: WMBF News
Abstract: Researchers are working on a vaccination that could protect humans from the West Nile Virus, and early tests of the vaccine look promising.
Inside the labs at the University of Oklahoma Health Sciences Center researchers are able to isolate strains of the west Nile virus and can then use a chemical which inactivates the virus basically rendering it harmless.
"We know that we can do it and we know through lab models that it can actually protect against infection," says Dr. James Papin one of the researchers involved in the experiments.
Researchers are now in the process of developing the actual vaccine which would then be followed by years of testing before it hits the market (WMBF News, 2012).
Title: Rogue Strain Of MMR Vaccine 'Caused Deafness'
Date: September 5, 2012
Abstract: Katie Stephen, who lost the use of her left ear days after being inoculated as a child, is reportedly the first known victim to prove her case to the Vaccine Damage Payments Unit.
But the 21-year-old has been refused the £120,000 payout for vaccine injury because it is only given to people with 60% disablement.
The measure used by the Department of Work and Pensions (DWP) to decide payouts defines single-sided deafness as 20% disablement.
It comes after a second victim, who lost hearing in both ears, received compensation in a previous case, the paper said.
Miss Stephen's mother Wendy said: "She wasn't born this way. This was done to her by the Department of Health. They distributed pamphlets arguing that this was the right thing to do for your child and not just that but the right thing to do for herd immunity in the UK against these three illnesses."
Paul Breckell, chief executive of Action on Hearing Loss, said: "We are disappointed that the formula used by the Vaccine Damage Payments Unit does not fully recognise the impact for Katie in completely losing the hearing in her left ear."
Miss Stephen, from Stonehaven, in Aberdeenshire, was 15 months old when she was given the inoculation in 1991.
A health visitor recorded hearing problems at 18 months old, although previous tests had been normal, and in 1996 she was diagnosed with deafness.
According to The Times newspaper, her medical records show that she was deafened by an MMR jab using the rogue Urabe strain of mumps, which was given to 5.4 million British children between 1988 and 1992.
In total, 10 cases of deafness after the jab were formally recorded at the time, the paper said.
An academic study found that the cause of deafness in six of those cases was unknown but MMR was a possibility, it added. Four of the suspect cases had single-sided deafness.
Asked why the industrial injuries measure was being used on vaccine-damaged children, a SWP spokeswoman said: "This is not in regulations - it was considered at the inception of the scheme that disablement should be assessed as a percentage similar to the system as applied in the War Pensions and Industrial Injuries Schemes."
She added: "The payments were set at the same level as the Industrial Injuries Benefit and does provide financial support to those eligible.
"Those who are eligible for this help may also be eligible for other support from the benefits system."
The Department of Health (DoH) stressed the importance of the MMR vaccine and said it had saved many lives.
Director of Immunisation Professor David Salisbury said: "It is important that parents get their child vaccinated against measles, mumps and rubella - all of which are highly infectious.
"Uptake rates for the MMR vaccine are at their highest level for 10
years and it is the best way to protect children against all three
infections" (Telegraph, 2012).
Title: Early Test Suggests Dengue Vaccine Possible
Date: September 12, 2012
Source: Fox News
Abstract: Results from an early test of a dengue vaccine suggest it isn't ideal, but scientists say the study is still encouraging news in the global fight against the disease known as "break-bone fever."
There is currently no treatment or vaccine for dengue, which causes symptoms including fever, severe joint pain, headache and bleeding. The mosquito-borne disease infects up to 100 million people worldwide every year, mostly in Asia, Africa and Latin America.
The research "provides the first evidence we could actually develop an effective vaccine against dengue," said Orin Levine, a professor at Johns Hopkins Bloomberg School of Public Health. He was not connected to the study, published online Tuesday by the journal Lancet.
"This is a milestone, but we're not there yet," he said.
Larger studies in about 30,000 people are now under way and should provide more information about the effectiveness of the vaccine made by Sanofi Aventis SA. Other dengue vaccines are being developed but Sanofi's is the furthest along.
The Sanofi vaccine was tested in more than 3,600 Thai children ages 4 to 11. More than 2,400 got three injections of the vaccine six months apart while about 1,200 got a rabies vaccine or a dummy shot. The study was paid for by Sanofi.
During about two years of follow-up, there were 134 dengue cases, including five severe cases. In the vaccine group, about 3 percent got dengue, compared to about 4 percent in the group that didn't get the shot. The difference wasn't big enough to suggest any benefit from getting the vaccine.
Scientists said the vaccine seemed partly effective against three of the four viruses that cause dengue and no unusual side effects were reported. The study took place during an outbreak of mostly type 2 dengue, which causes the most serious disease, but the vaccine didn't work against that kind.
"It's not exactly a slam dunk," said Scott Halstead, a senior scientific adviser for the Dengue Vaccine Initiative, who wrote an accompanying commentary. He said Sanofi might need to consider reformulating the vaccine or creating separate shots for each type of dengue.Joachim Hombach, a dengue expert at the World Health Organization, said it was encouraging that the vaccine appeared safe. "But the public health value of this vaccine remains to be demonstrated," he said (Fox News, 2012).
Title: MOH Will Administer Meningitis A Vaccine In The Three Northern Regions
Date: September 20, 2012
Abstract: The Ministry of Health in its efforts to reduce the incidence of meningitis epidemic that regularly hits the northern sector of Ghana has introduced a new vaccine “Meningitis A Conjugate Vaccine” (MenAfriVac) to prevent
Meningococcal Meningitis ‘A’ epidemic in the three northern regions.
The Meningococcal disease is an infection of meninges, the thin lining that surrounds the brain and the spinal cord. It is usually caused by a virus or bacterium (meningococcal).
The vaccine, specifically made for Africa, was expected to prevent 123,000 deaths by 2018; prevent permanent disability in 287,000 children and adults; prevent 11 million DALYs lost – the sum of year of potential life lost due to premature mortality and the years of productive life lost due to disability- and save approximately 99.7 million dollars in medical costs for diagnosis and treatment.
The new vaccine has already been introduced to Mali, Niger and Burkina Faso which is expected to be particularly effective in protecting children less than two years of age, which hitherto could not be covered under the old vaccine, the conventional polysaccharide vaccines.
The vaccine was funded by Global Alliance for Vaccines and Immunization, World Health Organization, UNCEF and Ministry of Health and would be administered free of charge to the public.
Dr Nana K.O. Antwi-Agyei, Programme Manager, Expanded Programme on Immunization (EPI) of the Ghana Health Service, said this at a press conference organized to highlight activities of the 2012 Meningitis ‘A’ Preventive Campaign.
He said they would embark on a 10-day mass immunization of Meningitis ‘A’ Vaccination Campaign in the three northern regions from October 2 to October 12, this year, on the theme: “Stop Meningitis, get Vaccinated Now”.
Dr Antwi-Agyei said the campaign was targeted at all persons from the age of one to 29 years who were the most vulnerable group when it came to meningitis epidemic.
He said evidence suggested the vaccine induces a higher and more sustained immune response in that age group and that explained why the GHS was targeting that age bracket.
The 10-day campaign, he said, was aimed at vaccinating at least 95 per cent of the target population.
He said other objectives of the MenAfriVac were to maintain stock of vaccines for epidemic response, enhance surveillance and national capacity building and improve case management.
He said the success of the campaign lay in the flow of the supply chain and the effectiveness of the social mobilization, and how all diverse events following immunization reported during and after implementation were treated and properly investigated.
Mr Rojo Metle Nunoo, Deputy Minister of Health, in a speech read on his behalf by Dr Addae Donkor, Deputy Director of GHS, said Ghana and other sub-Saharan countries have been experiencing explosive and repeated meningococcal epidemics over the years.
He said those epidemics occurred every eight to 12 years in 25 countries of the “meningitis belt’’ and around 450 million people in those areas were at risk of the disease.
“The epidemics usually start during the dry season (January to March) and end at the onset of the rainy season (May to June). An epidemic wave can last two to three years, and receding during intervening rainy season,” he said.
Mr Nunoo said over one million cases of meningitis had been reported in Africa since 1998.
He said in 1996 to 1997, one of the largest epidemic waves ever recorded swept across Africa, causing over 250,000 cases and 25,000 deaths.
“In Ghana, there were 18,703 cases and 1,356 deaths reported between November, 1996 and May, 1997 in the northern Sector,” he added.
He, therefore, encouraged the public the targeted areas to come out to participate in the programme.
Dr Iyabode Olusanmi, UNICEF Representative in Ghana, said Meningitis A vaccine had been tested and proven to be safe and several million doses had been given in several parts of the world, including neighbouring countries such as Burkina Faso, Mali and Niger.
She said all forms of adverse events following vaccination with Meningitis A Conjugate Vaccine were rare and occurred in about one to two per 10,000 people vaccinated.
“Severe adverse events occur in about one per 1,000,000 people vaccinated. Vaccines are constantly being monitored to ensure that any adverse reactions are recorded and investigated,” she said.
Dr Iddrisa Sow, World Health Organization Country Representative, said the initiative of manufacturing and making it available for affordable prices came after the 1996 and 1997 epidemic.
He said the Meningitis A Vaccines was a fast track vaccine with a South-South cooperation where India helped a lot.He said there were different types of meningitis and having the disease after the vaccine should not bring doubt about the efficacy of the meningitis A (GNA, 2012).
Title: ECDC Studies Shed New Light On Narcolepsy And H1N1 Vaccine
Date: September 20, 2012
Abstract: The European Centre for Disease Prevention and Control (ECDC) today confirmed a link between narcolepsy and pandemic 2009 H1N1 vaccination in children in Finland and Sweden, the two countries that originally reported a problem with the vaccine.
The agency summed up an extensive epidemiologic investigation in a technical report. The investigation combined two different studies conducted by the ECDC and the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium and includes a group of countries that reported possible pandemic vaccine–linked narcolepsy cases and ones that have not: Denmark, Finland, France, Italy, the Netherlands, Norway, Sweden, and the United Kingdom.
One study looked at the background rates of narcolepsy, and the other was a case-control study conducted to tease out risk factors.
The full 159-page report and a summary of the findings are available on the ECDC's Web page. Only one vaccine has been linked to the narcolepsy cases, Pandemrix, made by GlaxoSmithKline, which contains the company's proprietary AS03 adjuvant.
ECDC's probe follows a preliminary report that confirmed the narcolepsy link to the pandemic vaccine in Finland. The link first came to light in August 2010 when a Finnish pediatric neurologist noted a slight rise in narcolepsy cases. Around the same time, Swedish experts noticed a similar pattern in kids who had received Pandemrix.
In July 2011 European drug regulators reviewed the link and recommended a labeling change that limited the vaccine's use in children and teens to instances in which protection for the 2009 H1N1 virus was needed and other seasonal trivalent vaccines weren't available.
To conduct the background study, investigators used eight large linked healthcare databases from seven countries. They found that before 2009 H1N1 vaccination campaigns, narcolepsy incidence over a 10-year period was stable, about 0.85 diagnoses per 100,000 population, with rates that were lower in kids.
For the case-control study, researchers used a common protocol, case report form, and case definition, and they had detailed instructions for collecting data.
They found that new cases of narcolepsy reported after the pandemic vaccine launched in the fall of 2009 increased significantly in Sweden and Finland compared with other countries. They found no increased incidence in the Netherlands, the United Kingdom, and Italy, though they noted that vaccine uptake in children ages 5 to 19 was low in those countries.
A strict primary analysis to avoid biases such as media awareness and diagnostic awareness effects found no significant risk to kids in countries apart from Sweden and Finland.
A sensitivity analysis based on onset of excessive daytime sleepiness before media attention, however, found an increased risk of narcolepsy in kids following 2009 H1N1 vaccination both in countries that had and hadn't reported a problem with the vaccine. A similar analysis suggested an association in adults before awareness increased in countries that hadn't reported a vaccine-narcolepsy link.
The group recommended further studies that boost statistical power by including more cases collected from the period before awareness increased and including more European countries that had significant vaccine coverage, such as Ireland. In April, Ireland's health department reported a 13-fold greater risk of narcolepsy in kids who received the Pandemrix vaccine.
The investigators also suggested that an understanding of the vaccine-narcolepsy link could be strengthened by pooling national studies that weren't included in today's report, such as sleep-study–based investigations and those from Ireland, the United Kingdom, and Germany.
The researchers also recommended expanding the investigation to countries outside Europe—such as Canada and Brazil—that used pandemic vaccine with the AS03 adjuvant but didn't have as much media attention about the narcolepsy link.
Future studies should also assess possible links in countries that used different 2009 H1N1 vaccines, adjuvanted and unadjuvanted, the authors concluded (CIDRAP, 2012).
Title: Doctor: Injection Can 'Cure' PTSD In Veterans
Date: September 21, 2012
Source: Fox News
Abstract: A federally-approved injection is offering new hope to veterans suffering from post-traumatic stress disorder (PTSD). The injection, which takes approximately 15 minutes to administer, has led to dramatic improvements in some veterans who suffer from the disorder.
With 23,000 soldiers set to withdraw from Afghanistan this year, somewhere between 11 to 20 percent of them will suffer from PTSD, according to estimates from the Department of Veterans Affairs.
PTSD is an anxiety disorder that typically follows exposure to a traumatic event such as combat, disaster or assault. Symptoms include nightmares, jumpiness, paranoia, irritability and aggressiveness. It is often accompanied by depression, substance abuse or other anxiety disorders.
To address the soldiers who aren't finding relief from standard therapies, Dr. Eugene Lipov, medical director of Advanced Pain Centers in Chicago, director of pain research at Northwest Community Hospital and medical director of Chicago Medical Innovations, is championing a little-known treatment called Stellate ganglion block (SGB).
According to Lipov, PTSD sufferers who have been administered the block have reported relief from symptoms in as little as 30 minutes.
Lipov has received a waiver from the FDA to perform SGB and is currently recruiting participants for a clinical trial. SGB, which has also been used in the past to treat depression, schizophrenia, psychosis, and other mental health disorders, is not backed by the Department of Veterans Affairs for treating PTSD in soldiers.
For the treatment, local anesthetic - commonly used in epidurals during labor - is injected into a collection of nerves in the neck known as the stellate ganglion. These nerves are connected to various parts of the brain, including the amygdala, which are thought to be associated with PTSD.
One theory behind the development of PTSD suggests that when a person is under massive stress, the level of nerve growth factor (NGF) in his or her system increases. NGF prompts the growth of new sympathetic nerves, which release a hormone called norepinephrine.
Norepinephrine underlies the "fight-or-flight" response in the
body and directly increases heart rate and blood pressure. Researchers
such as Lipov believe high levels of NGF in people with PTSD are directly
responsible for their heightened sensitivity to environmental stimulus.
SGB essentially "turns off" the NGF activity, leading to the decline of norepinephrine in a person's system.
"As long as NGF continues to be active it maintains the extra growth of [sympathetic] nerves, or 'leaves,'" Lipov said. "NGF is the fertilizer for these leaves, so the procedure takes away the fertilizer."
"I've seen soldiers going 120 miles an hour before the block, and 30 minutes later in the recovery room, they'll say, 'I'm chilling now; I'm ok,'" he added.
So far, Lipov has treated 65 patients from 25 states and one person from New Zealand. The cost of the injection is approximately $1,000 and is fully covered by his non-profit Chicago Medical Innovations.
Lipov said the procedure works in 70 percent of patients, and they show at least 50 percent improvement in symptoms.
"The most marked improvement is in sleep -the nightmares going away," he said.
Living with PTSD
For some PTSD sufferers, like Raleigh Showens, 65, of McHenry, Ill., the injection is a last resort measure to find relief - and literally, a matter of life or death.
Showens, who was a MedEvac for 19 months, said while he never saw combat in Vietnam, he witnessed the horrific results.
"I saw the death and destruction, and I was just 19," Showens said. "We flew in Easter Sunday of '67, and we were loading a lot of bodies in...I was sick, and I had a nurse come up, put her arms around me and say, 'Soldier, you're going to have to get tough.'"
While Showens learned to block out things he saw during the war, when he returned home a year and a half later, he had trouble re-adjusting to civilian life.
"My family and friends all said, 'You're not the same person,' and it bothered me," Showens said. "I could see the difference, too. I was short-tempered and on edge all the time, but I didn't know what to do about it."
Showens turned to alcohol to bury his problems. The VA also prescribed him various medications to help with his depression and sleeping problems.
Iraq veteran Chris Carlson, 41, from Lombard, Ill., did two tours in Afghanistan and one in Iraq during Operation Iraqi Freedom, and reported similar experiences when he came home.
"I started reliving some of the experiences and what I saw," Carlson said. "I had horrible nightmares and would wake up in cold sweats. It got worse and worse as time went on."
Carlson said he would wake up and start drinking alcohol. "Instead of coffee, I'd be drinking beer first thing in the morning," he said.
Showens lived with his symptoms for more than 40 years until December 2010, when he met Lipov at a political rally. At the time, Showens was contemplating the idea of committing suicide.
"I was tired of living that way," he said. "I was tired of putting my family through it."
The injection was a last ditch attempt to cure his PTSD. "If it didn't work, nobody could look at me and say, 'You should have tried this, and you didn't,'" Showens said. "I didn't even think about it or hesitate. What difference would it make? I already had my destiny planned."
Showens went in for the injection on December 20. Despite his expectations, within a half hour, he felt relaxed. But something even more remarkable happened later that night.
"I had had nightmares - pretty much destroyed the house every night since 1968," Showens said. "I can honestly say that night was the first time I slept all the way through the night without a nightmare."
He added when his nightmares returned a week later, he had to go back in for a second injection. Since then, he's been living without PTSD symptoms and off medications.
"We don't know why sometimes it takes more than one block to [relieve PTSD symptoms]," Lipov said. "I think sometimes the first doesn't take away enough NGF. Sometimes, we have to do five or six injections."
Carlson experienced drastic improvements as well after his first injection.
"I was skeptical," Carlson said, "Like, a needle in my neck, how will that help me? But immediately I felt so much better physically, mentally and emotionally."
Carlson ultimately required a second injection, like Showens, but said he has been symptom-free for 10 months. He has also stopped drinking.
"It's really hard to explain," Carlson said. "I was in this deep depression, hearing things, always looking out windows or under doors...but now all that stuff isn't affecting me. I just feel so much better."
Standard treatments for PTSD include psychological approaches such as cognitive behavioral therapy and a class of medications called selective serotonin reuptake inhibitors (SSRIs), often used in conjunction with one another.
However, according to Dr. Paula Schnurr, deputy director at the National Center for PTSD, only 30 to 40 percent of patients officially go into remission from these treatments.
The actual remission rates may be higher, according to Schnurr, but it can be difficult to gage success in a rigorous, scientific study.
The VA and Department of Defense fund select experimental treatments for PTSD, not including SGB, which Schnurr said they choose based on evidence supporting the treatments and outcomes of the patients.
"In the field, we've got more treatments but also challenges to make them better and more efficient and more effective in patients," Schnurr said. "We're not 100 percent there yet" (Fox News, 2012).