News

Federal court rejects vaccines-autism link

Liz Jones — Wed, 17 Mar 2010 15:55:24 -0400

A federal court has determined that the theory that thimerosal-containing vaccines cause autism is "scientifically unsupportable," and that the families of children diagnosed with the condition are not entitled to compensation.

Three special masters in the U.S. Court of Federal Claims determined that families of Jordan King, William Mead and Colin Dwyer didn't prove a link between the vaccines and autism. The three released more than 600 pages of findings after reviewing these test cases.

Although Special Master George Hastings was sympathetic with the King family and believed they brought their claim in good faith, he found "the opinions provided by the petitioners' experts in this case, advising the King family that there is a causal connection between thimerosal-containing vaccines and Jordan's autism, have been quite wrong."

Special Master Patricia Campbell-Smith expressed doubt that the amount of inorganic mercury deposited in the brain from the vaccines could cause the effects the Mead family had alleged. "Inorganic mercury is not the form of mercury understood to be most toxic in the doses involved in childhood vaccines, and a normal fish-eating diet by pregnant mothers produces a greater source of inorganic mercury for deposition in the brain than thimerosal-containing vaccines do," Campbell-Smith writes.

As CNN notes, the special masters' decisions are subject to review by judges in the U.S. Court of Federal Claims. Within the next 30 days, attorneys for the families will ask the claims court judges to review the decisions and rule that the children are entitled to compensation. In addition, the Supreme Court recently granted certiorari in the case over the question of whether people injured by vaccines can sue drugmakers in state and federal court.

The court's decision comes shortly after the release of a survey on parents' vaccine choices for their children. Results of the survey showed that a quarter of parents indicated they believe vaccines can cause autism. However, they were surveyed more than a year before the Lancet decided to retract Andrew Wakefield's controversial study linking vaccines to autism.

- see Campbell-Smith's decision
- read Hastings' decision
- see Denise Vowell's decision
- find more at CNN

WHO suspends Indian vax purchases as it probes quality

John Carroll — Wed, 17 Mar 2010 15:07:36 -0400

Perplexed by the appearance of mysterious white sediment inside vials of vaccine produced by an Indian subsidiary of Sanofi-Aventis, the World Health Organization has suspended the purchase and distribution of its Shan5 jab. According to Sanofi, the move comes as a "precautionary measure pending outcome of an investigation of vaccine quality."

A spokesperson for the WHO insists that there have been no safety problems yet discovered with the vaccine, a shot that provides protection against diphtheria, pertussis, tetanus, Haemophilus influenza B, and hepatitis B. However, even after vigorous shaking, the sediment was hard to disperse. And that, she adds, is a rare problem.

India's Shantha Biotechnics landed a contract valued at $340 million last fall to supply the vaccine to the WHO through 2012--just months after Sanofi bought it.

- here's the Wall Street Journal report

Merck joins coalition backing cutting-edge vaccine plant

John Carroll — Thu, 11 Mar 2010 10:32:25 -0500

Merck, IBM and Battelle have signed up to partner with GE Healthcare on a new, state-of-the-art vaccine plant that has been proposed by the University of Pittsburgh Medical Center.

The vaccine facility backers want to build a new vaccine facility using cutting-edge technologies that can respond on an emergency basis to bioterror attacks, according to a report in the Pittsburgh Business Times. Merck would contribute its drug-development expertise, with IBM handling IT and Battelle doing the pre-clinical work and research.

UPMC set up a nonprofit corporation for the vaccine manufacturing project, which they propose building near the old Pittsburgh airport. Backers say the facility would employ 1,000 people.

"We are committed to solving the most critical problems in human health and stand ready to be a full partner in this impressive public-private initiative," Battelle Vice President John Wade said in a statement.

- check out the story from the Pittsburgh Business Times
- here's the press release

(Editor's Note: This story originally appeared citing figures on the overall cost of the plant and partner contributions which UPMC officials say were not correct. This version corrects the story and adds the link to the official release as well as the corrected PBT piece.)

BioSante cancer vax promising in small study

John Carroll — Thu, 11 Mar 2010 10:16:29 -0500

Shares of BioSante Pharmaceuticals surged this morning in pre-market trading after the developer said that a 19-patient study demonstrated the promise of its GVAX leukemia vaccine to mop up the stubbornly lingering cancer cells of CML patients taking Gleevec. Researchers said that the 19 patients in the study had measurable levels of cancer cells even though they had been on Gleevec for at least a year. After a median of 17 months, 13 of the patients saw their number of cancer cells decline, and seven emerged with undetectable levels. Report

New brain cancer vaccines target tumor cells

John Carroll — Thu, 11 Mar 2010 04:41:19 -0500

CNN takes an in-depth look at the research being done on new therapeutic vaccines for glioblastoma, a lethal brain cancer that has virtually always carried a death sentence with each diagnosis.

One prominent project involves CDX-110, a vaccine that was first developed at Celldex and then partnered with Pfizer, which triggers a T-cell attack on EGFR factor three, a protein produced by 40 percent of tumor cells.

Dr. John Sampson tells CNN that EGFRviii is a kind of genetic fingerprint that plays a crucial role in spurring a targeted immune response.

But a separate program underway at UC San Francisco is even more targeted. University researchers are developing a therapeutic vaccine using the tumor cells taken from each patient. In this case the target is heat-shock protein, also made by tumor cells. And the work is completely funded by the NCI and non-profit groups.

"This is the ultimate personalized medicine," says Dr. Andrew Parsa. "It's like having a lot of little medicines instead of one big blockbuster."

- here's the story from CNN

Vaccination campaigns beat back viral hepatitis

John Carroll — Thu, 11 Mar 2010 04:24:48 -0500

The most serious types of viral hepatitis show signs of a steady retreat, beaten back by years of persistent vaccination campaigns in the U.S. Experts at the CDC say that there's been a decrease of hepatitis A infections in adults, a big drop in hepatitis B infections in people aged 6 to 39 and a slide in hepatitis C cases in the group considered most at risk.

Decades of vaccination campaigns against hepatitis A and B appear to have worked on that front, while the CDC says that hepatitis C cases may be falling as a result of a campaign to warn people away from the kind of risky behavior that spreads the virus.

Hepatitis B and C can both trigger chronic infections leading to liver disease and cancer. And HealthDay also notes that hepatitis C is the most commonly seen blood borne infection in the country. HCV is also a big target for drug developers--like Vertex--interested in grabbing a share of a huge market. And like HIV, developers are targeting a new generation of combination therapies.

"It really became clear early on that these hepatitis C agents couldn't really be given [as single agents] because of the virus's ability to develop resistance," Vertex CMO Bob Kauffman recently told Xconomy. Other drug projects are underway at Abbott Laboratories, Merck, Anadys and Gilead.

- here's the story from HealthDay

SCOTUS agrees to take vaccines case

Liz Jones — Wed, 10 Mar 2010 14:48:22 -0500

The U.S. Supreme Court has granted certiorari in the case over the question of whether people injured by vaccines can sue drugmakers in state and federal court.

SCOTUS Monday agreed to hear an appeal from parents of Hannah Bruesewitz, who suffers from seizures after taking a DTP vaccine from a batch made by Wyeth. The U.S. Court of Appeals for the Third Circuit in Philadelphia affirmed a lower court ruling that Robalee and Russell Bruesewitz couldn't sue Wyeth in that court for their child's injury because the National Childhood Vaccine Injury Act "preempted all design defect claims." It also ruled the parents hadn't demonstrated that Wyeth failed to adequately warn them about the risks associated with the vaccine.

As BNet notes, any allegation of injury or death associated with a vaccine gets heard by a federal vaccine court, where damages are capped at $250,000. This arrangement gives injured parties somewhere to get justice while protecting vaccine makers from the financial ruin these cases would bring if they were heard by regular juries.

The Philly court's ruling contrasts with a October 2008 decision by the Georgia Supreme Court, which upheld a judgment by a state appeals court. The appeals court had ruled in favor of a couple who sued several vaccine manufacturers, alleging their son suffered neurological damage caused by vaccines containing thimerosal, a mercury-based preservative. The appeals court was the first in the nation to decide that the National Childhood Vaccine Injury Compensation Act doesn't preempt state law permitting such lawsuits.

Wyeth is joining in asking the Supreme Court to hear the case, saying it presented an important and recurring legal issue that should be resolved, the Philadelphia Inquier notes.

Although the Bruesewitz case isn't directly related to autism, Jim Edwards of BNet and In the Pipeline's Derek Lowe believe the vaccines-cause-autism crowd will be watching this case with great interest. And--based on SCOTUS' decision--they will be preparing, as Edwards writes, to flood courts with more than "5,000 lawsuits advancing the wrong-headed claim that vaccines cause autism." Edwards asserts that such lawsuits could threaten the vaccine supply, as the extra legal costs would put vaccine makers out of business.

Word of SCOTUS' decision comes a little over a week after the publication in the journal Pediatrics of survey results of 1,552 parents with children younger than 17 years. A wide majority of respondents (90 percent) agreed that getting vaccines is a good way to protect their children from disease; however, a quarter indicated they believe vaccines can cause autism. The parents were surveyed more than a year before the Lancet decided to retract Andrew Wakefield's controversial study linking vaccines to autism.

The study authors maintain it is likely parents would benefit from programs that highlight the rigorous safety assessments vaccines must go through before licensure and subsequent recommendation. "[I]f current safety concerns are not addressed effectively and increase in the future," more parents might refuse vaccines, reducing their child's protection against a potentially preventable disease, the authors caution.

- read the Inquier's coverage
- check out BNet's take
- see the post by Derek Lowe

Experts ponder why regular flu season is a no-show

John Carroll — Thu, 04 Mar 2010 09:59:41 -0500

The flu season has gone missing, and experts are trying to figure out what happened.

After spreading swiftly in the summer and fall, swine flu has all but disappeared. And the regular outbreak of influenza that usually hammers hundreds of thousands of people by this time every year has yet to happen. In late February, flu inspired 1.8 percent of all visits to the doctor, according to the latest figures from the CDC. And that's well below the norm.

It's not the result of a major vaccination campaign, says Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. There are multitudes of people in the U.S. who have not been vaccinated or infected. Some of the experts attribute the odd lull to the earlier spike in swine flu cases, noting that influenza typically rolls through a country in waves. Others suspect swine flu spurs a chemical that provides some level of immunity.

Regardless, flu watchers aren't letting down their guard. Influenza experts will stay alert to any new outbreaks, ready to rush vaccine where it may be needed. And, unlike previous years, there's no shortage of shots to report.

- here's the story from the Wall Street Journal

Professor's new chip delivers vaccines without the pain

John Carroll — Thu, 04 Mar 2010 08:45:02 -0500

After a six-year quest, a Japanese scientist at Kyoto Pharmaceutical University has unveiled a small chip designed to deliver vaccines without breaking the skin--or causing any pain.

Kanji Takada tells the Telegraph that the chip incorporates 300 tiny "needles" that administer a vaccine just below the surface of the skin without penetrating it. "The patch can be used to deliver any type of vaccine and people are not frightened of having the injection because they feel nothing at all," explains Professor Takada.

Takada says he was challenged to succeed where others had failed using microneedles made of sugar. The professor opted for a water-soluble polymer that dissolved once it had been pushed into the epidermis, the skin's outer layer. And he says it should be available in Japan in two years.

- here's the story from the Telegraph

Study: Parents need to be better informed about vaccines

Liz Jones — Wed, 03 Mar 2010 16:17:42 -0500

Public health officials need to redesign vaccine information programs to address parental safety concerns or continued high childhood immunization rates will be at risk, conclude the authors of a study published recently in the journal Pediatrics.

Michigan researchers sent surveys to parents with children younger than 17 years in January 2009 and received 1,552 responses. A wide majority of respondents (90 percent) agreed that getting vaccines is a good way to protect their children from disease, and 88 percent said they generally listen to their doctors about vaccines. However, 54 percent said they had concerns about the potential for serious adverse effects of vaccines, and a quarter indicated they believe vaccines can cause autism. The parents were surveyed more than a year before the Lancet decided to retract Andrew Wakefield's controversial study linking vaccines to autism.

A number of parents (11.5 percent) said they had refused a vaccine for their child that their doctors had recommended. Researchers found parents were more likely to refuse the newer vaccines--specifically those that protected against chickenpox, HPV and meningitis. Of those who had refused a vaccine, more than half (56.4 percent) had turned down the HPV vaccine, and a just under a third had declined the chickenpox and meningitis vaccines (32.3 percent and 31.8 percent, respectively). Only 17.7 percent had refused the older MMR shot.

The potential for adverse events and the relative newness of the vaccines were the most frequently given reasons for refusing a vaccine. For example, 78 percent of those who had said no to the HPV vaccine agreed that there hasn't been enough research done on it, while three-quarters said that it hadn't been on the market long enough. Merck's Gardasil was licensed in 2006, while GlaxoSmithKline's Cervarix was approved in October. Just over half said that moral or ethical concerns led them to refusing the HPV vaccine for their children.

The authors maintain it is likely parents would benefit from programs that highlight the rigorous safety assessments vaccines must go through before licensure and subsequent recommendation. "[I]f current safety concerns are not addressed effectively and increase in the future," more parents might refuse vaccines, reducing their child's protection against a potentially preventable disease, the authors caution.

- download a .pdf of the study

Vaccine reverses Parkinson's disease in animal study

John Carroll — Wed, 03 Mar 2010 14:10:29 -0500

An experimental vaccine being studied at the University of Nebraska Medical Center successfully spurred the development of dopamine-producing nerve cells, reversing Parkinson's disease in mice. And after more than a decade of work, the scientists are anxious to determine if the same vaccine strategy will work in humans.

The key to the vaccine's success, the researchers say, is its ability to get T cells to migrate to the areas of the brain damaged by the neurodegenerative disease. "We believe this could be a revolutionary means for Parkinson's therapeutics," says Howard Gendelman, who partnered with R. Lee Mosley on the research.

"The identical immune deficits seen in mice are being looked at in humans with Parkinson's," Dr. Mosley says. "Early results are encouraging. This should pave the way for researchers to begin follow-up studies on the Parkinson's treatments and open up new opportunities to realize an immunization approach for other neurodegenerative disorders such as Alzheimer's disease and amyotrophic lateral sclerosis (Lou Gehrig's disease)."

University officials say they have filed a patent application and plan to begin talks with potential commercial partners on the vaccine.

- here's the press release
- here's the story from the Omaha World-Herald

Scientists easily create hybrid virus

John Carroll — Thu, 25 Feb 2010 10:25:26 -0500

A simple, single gene swap was all it took to create a hybrid bird and swine flu virus, according to an international team of scientists. Dr. Yoshihiro Kawaoka, professor of pathobiological sciences in the School of Veterinary Medicine at the University of Wisconsin-Madison, says that the prospect of a bird/swine flu virus--which would be much more lethal than the current pandemic--makes it essential for close global monitoring of new outbreaks. Report

Older women unlikely to benefit from HPV vax

John Carroll — Thu, 25 Feb 2010 10:08:54 -0500

A new study concludes that women over the age of 40 are unlikely to benefit from an HPV vaccine.

Researchers tracked the experiences of 9,000 Costa Rican women ages 19 to 97 years, screening them for HPV infections, which can trigger cervical cancer. The rate of newly detected infections plunge from 35 percent for women 19 to 25 to 13.5 percent for women over the age of 42. Typically those infections cleared up without treatment.

"Because the HPV vaccine can only prevent infections, and these women are not getting that many new infections, the potential benefit of HPV vaccination among older women is very limited," says Dr. Ana Cecilia Rodríguez, the lead author.

- check out the study abstract
- here's the report from the New York Times

Prevnar 13: Pfizer's next Lipitor?

Liz Jones — Wed, 24 Feb 2010 16:16:24 -0500

Pfizer got double good news Wednesday after the FDA approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the company's 13-valent pneumococcal conjugate vaccine. It is the updated version of Prevnar and protects against six additional strains of bacteria.

The same day, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the use of Prevnar 13 for healthy children between the ages of 2 and 59 months. ACIP also recommended that children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.

Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease--including sepsis, bloodstream infections and meningitis--caused by 13 Streptococcus pneumoniae.

The L.A. Times notes that Prevnar was the world's top-selling vaccine in 2008 with sales of $2.7 billion and was considered a key product in Pfizer's decision to purchase its rival Wyeth. And Matthew Herper of Forbes' health blog predicts that the vaccine could be Pfizer's top seller after Lipitor loses patent protection.

Pfizer expects to start selling Prevnar 13 in the U.S. during the first quarter. Already approved for infants and young children in 38 other countries, Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected later in the year, according to a Pfizer statement. Earlier this year, the company said that Prevnar 13 sales in adults older than 50 could account for $1.5 billion in sales.

Pfizer's stock jumped 1.5 percent to $17.94 yesterday following the approval, according the Financial Times.

- see Pfizer's statement about the FDA approval
- check out the CDC announcement
- read the FT's coverage
- read the Forbes' blog post
- check out the L.A. Times' review

Decision to scrap HIV vax facility stirs controversy

John Carroll — Wed, 24 Feb 2010 14:36:25 -0500

Canadian public health officials and representatives for the Gates Foundation confirmed recently that they are shelving plans for an $88 million facility to manufacture experimental HIV vaccines. The decision has triggered a brewing controversy among scientists in the field, as well as some harsh criticism from the companies that hoped to win the contract to build and operate it.

Dr. Bill Cameron, president of the Canadian Association of HIV Research says he was disappointed to hear that the project was being scrapped. "You can't test a vaccine without a production facility," he says, adding that researchers would find their work harder to complete. He also noted that academic researchers in particular needed access to a public manufacturing facility.

"The whole point ... was to have a not-for-profit facility for repeatedly and cheaply testing for vaccines," Terry Duguid, the former CEO of Winnipeg bidder International Centre for Infectious Diseases, tells the Montreal Gazette. "It's not designed to make money. It's designed to break even."

But the Canadian government and Gates officials aren't apologizing. They say they had decided to back off after finding that there was plenty of manufacturing capacity available for the work. Also, new criteria is making it tougher to get a new HIV vaccine into clinical trials, which in turn is cutting demand for the manufacturing services.

- here's the article from the Montreal Gazette

Related Article:
Politics at play in Canadian HIV plant

DARPA providing $40M for tobacco vax project

John Carroll — Wed, 24 Feb 2010 14:14:17 -0500

The R&D arm of the U.S. Department of Defense is bankrolling a consortium involved in a quest to produce vaccines in genetically-engineered tobacco plants. Appalled by the slow-motion response of manufacturers to the sudden appearance of the swine flu pandemic, federal officials are hoping that their assistance can help trigger a game-changing advance in vaccine technology.

The Defense Advanced Research Projects Agency--best known as DARPA--is providing $40 million for 10 million doses of H1N1 vaccine. Texas A&M and the privately operated G-Con will invest another $21 million in the project, which has been dubbed GreenVax. The consortium says they can eventually push production to 100 million doses a month.

In recent years, a number of research projects have revolved around producing vaccines in animals and plants. Arizona State researchers produced a West Nile vaccine in plants that proved promising. And, as the Wall Street Journal notes, tobacco has emerged as one of the most promising vehicles for new vaccine production. It's cheap to grow and could be used to produce a bumper crop of new vaccines. Medicago has reported progress with its tobacco-based vaccine for bird flu.

GreenVax is working with technology that was developed at Fraunhofer USA Center for Molecular Biotechnology in collaboration with iBio. But success won't come easily. The U.S. and most other countries have seen a growing ambivalence to anything new in vaccines, an industry which has been dogged by bad science and vehement critics.

- read the story from the Wall Street Journal
- and here's the report from the Houston Chronicle

Study: No hard evidence that flu vaccine protects the elderly

John Carroll — Thu, 18 Feb 2010 09:01:16 -0500

After a detailed analysis of 75 scientific studies, a group of researchers at the Cochrane Library has concluded that there's little hard evidence to prove that the annual flu vaccination campaign for the elderly does any good.

The vaccine won't work unless it's particularly well matched to the flu strains in circulation, say the researchers. Some of the elderly don't respond to the vaccine at all, and the most vulnerable often don't bother to get a shot. And the data on flu rates in older people is often badly skewed by ailments that have the same symptoms as flu but aren't affected by vaccine at all.

The analysis drew considerable attention in the U.K., where the government pays about 150 million pounds a year to vaccinate three quarters of the older population. Officially, the government estimates that the flu kills about 12,000 people a year in England. But the Cochrane group says there really are no good estimates available and the government figure is probably far too high.

"As the evidence is so scarce at the moment, we should be looking at other strategies to complement vaccinations," notes Tom Jefferson of the Cochrane Collaboration in Rome. "Some of these are very simple things like personal hygiene, and adequate food and water. Meanwhile, we need to undertake a high quality, publicly funded trial that runs over several seasons to try to resolve some of the uncertainties we're currently facing."

There's been widespread recognition among vaccine manufacturers that the currently available vaccines are least effective in the elderly. And there are a number of new programs underway to design a vaccine that can protect this patient population.

- here's the press release
- here's the story from The Telegraph

Novartis VC arm backs fledgling universal flu vax

John Carroll — Wed, 17 Feb 2010 16:29:08 -0500

The venture arm of Novartis has joined a group of investors channeling $13.6 million in fresh funds for Immune Targeting Systems, which is hard at work on an experimental universal flu vaccine.

ITS said on Wednesday that the funds would allow researchers to push FP-01 through proof-of-concept studies, with Phase I studies kicking off this year. Its vaccine, one of a number of universal flu vaccines in the clinic, uses nanoparticles to deliver high density antigens to the immune system.

Sweden's HealthCap, Truffle Capital of France and London Technology Fund joined Novartis Venture Fund in the round. Their money brings ITS's Series A round to 13.15 million pounds.

"We believe strongly in the need to enhance T-cell immunity in vaccinology, and we are delighted that ITS is advancing its unique technology and lead program to clinical validation," says Florent Gros, managing director at Novartis Venture Fund.

- here's the press release
- check out the Reuters story

Peptide could be clue for cancer vax

Liz Jones — Wed, 17 Feb 2010 16:21:30 -0500

In a recent study, 100 percent of mice vaccinated with a peptide remained tumor-free for at least 60 days after inoculation with colon cancer cells. And scientists from the University of Colorado School of Medicine and National Jewish Health say this method could be a key in developing vaccine for a range of cancers.

Scientists have known that there are T-cells inside tumors, meaning the body does have a natural--albeit mild--immunity to cancer. The T-cells inside tumors recognize antigens on the surfaces of tumor cells, but don't bind to them strongly enough to sound an alarm or initiate a robust immune response.

Jill Slansky, associate professor in the Integrated Immunology Department between National Jewish Health and the University of Colorado School of Medicine, hypothesized that previous vaccine candidates were unsuccessful because they did not bind strongly enough to the T-cells found inside tumors. So, she, structural biologist John Kappler, and postdoctoral fellow Kimberly Jordan designed peptide vaccines that resemble naturally occurring antigens but bind more strongly to the T-cells found inside tumors.

"Our theory about the importance of the T-cell peptide bond was correct, but we learned that the peptides must also stimulate T-cells that cross react with the existing antigens and produce a large population of activated T-cells," Kappler says in a statement. The results were published in the Feb. 16 issue of the Proceedings of the National Academy of Sciences.

- check out the press release

Related Article:
Pitt researchers test colon cancer jab

Dehydration process could eliminate the vax cold chain

John Carroll — Wed, 17 Feb 2010 15:32:47 -0500

One of the Holy Grails of the vaccine industry is cheap, effective technology that will do away with the need for a complex and pricey cold chain to guard supplies. And now scientists at Oxford University and Nova Laboratories say that new sugar technology can be used to do just that.

By mixing the vaccine with the sugars trehalose and sucrose, the scientists can dehydrate the vaccine in a filter and preserve the active ingredient--even in tropical climates. Once the vaccine reaches its destination, it can be rehydrated in a matter of seconds.

"Currently vaccines need to be stored in a fridge or freezer," explains lead author Matt Cottingham of the Jenner Institute at the University of Oxford. But if one were able to ship vaccines at normal temperatures, vaccines would be more readily available--and come at a lower cost. "You could even picture someone with a backpack taking vaccine doses on a bike into remote villages," Cottingham adds.

In wealthy countries, the cold chain is expensive to maintain. But in poorer countries, the chain often either doesn't exist or has big gaps that prevent the delivery. "If most or all of the vaccines could be stabilized at high temperatures, it would not only remove cost, more children would be vaccinated," Adrian Hill of Oxford University says in a statement.

- read the Oxford release
- here's more from Reuters

Related Article:
PATH finds cheap method to guard vax stocks

WHO to update its pandemic alert

John Carroll — Thu, 11 Feb 2010 11:06:15 -0500

Eight months after declaring the world's first pandemic in more than four decades, the World Health Organization says it will once again summon its experts to determine if the worst of the outbreak is over.

The WHO wants to see if it should alert health authorities around the world to resume planning for more normal patterns of flu seasons. But even so, they are likely to flag the probability of new H1N1 outbreaks, as West Africa has seen recently.

"The ending of a pandemic cannot be construed an abrupt on-or-off situation," said Keiji Fukuda, the WHO's top flu expert.

The pandemic has sparked controversy around the globe as the swine flu virus turned out to be far milder than originally feared. Large majorities in many affluent countries shunned the new flu vaccine that was churned out in record time. And poor countries which couldn't afford vaccine have been left in line waiting for supplies even as the most developed nations tried to figure out what to do with their surpluses.

- here's the story from Reuters

Study: Obesity can blunt effectiveness of hep B vaccine

John Carroll — Thu, 11 Feb 2010 08:44:58 -0500

An epidemic of obesity in American teens is forcing clinicians to reconsider how they vaccinate young people.

A new study says that obese teens will need longer needles if they're to be effectively vaccinated against hepatitis B. In a study of 22 obese teens, investigators found that the standard one-inch needle spurs only a weak response to the vaccine while a 1.5 inch needle provided a higher antibody count.

"As obesity rises in the U.S., we need to be aware that the standard of care may have to change to protect obese youth," study co-author Dr. Amy Middleman of Baylor College of Medicine in Houston tells Reuters.

There may be a bonus here for patients, though. Experts say that longer needles are less painful and associated with fewer side effects than short needles.

- here's the story from Reuters

Rising vax sales juice Sanofi's revenue numbers

John Carroll — Wed, 10 Feb 2010 14:39:52 -0500

Sanofi-Aventis saw its net profit surge in the fourth quarter of 2009 as sales of the H1N1 vaccine hit 465 million euros (roughly $638.3 million). And Wayne Pisano, who helms the company's vaccines business, said he expects the company to match that figure in the first four months of 2010.

The release, though, inspired some pointed questions about the company's H1N1 performance compared with GlaxoSmithKline, a Big Pharma competitor in the vaccine business that has recorded £883 million in annual sales of the swine flu vaccine. Sanofi CEO Chris Viehbacher said that Glaxo's ability to charge more in some markets because of the adjuvant in its vaccine may have provided the company with a bigger windfall. He added that Glaxo likely produced more swine flu vaccine last year while Sanofi took the lead in seasonal flu vaccine.

Vaccines have been a growth arena for Sanofi, which has been an active acquirer of small and medium-sized companies. And Viehbacher pointedly remarked that the company is far from finished on that score. He added, though, that mega-mergers aren't in the cards.

As the New York Times points out, Sanofi has been regrouping under Viehbacher, and vaccines are one of its three core spheres.

- check out the Dow Jones report
- here's the feature from the New York Times

Lancet editor on autism study: "We (all) really messed up."

John Carroll — Wed, 10 Feb 2010 14:30:03 -0500

Since The Lancet's recent decision to formally retract the controversial study connecting autism and childhood vaccines, there has been endless discussion about the enormous long-term fallout from the study. Millions of parents prevented their children from getting vaccinated as a result of their unfounded fears.

The New York Times asked Dr. Richard Horton, editor of The Lancet, how bad science made its way into a good science publication. His response:

"This was a system failure. We failed. I think the media failed. I think government failed. I think the scientific community failed, and we all have to very critically examine what part we played in this. I think the media certainly did sustain the story over a decade. It became a political story with "Did Tony Blair have his son vaccinated with M.M.R. or not?" Suddenly a huge media furor around that. ... I think we all have to look very carefully at ourselves and say, "We really messed up here."

- here's the story from the New York Times

Lancet retracts controversial autism study

John Carroll — Thu, 04 Feb 2010 09:46:28 -0500

Twelve years ago, Dr. Andrew Wakefield published a study in the Lancet that linked autism with childhood vaccines, triggering an explosive controversy that continues to influence public opinion about the potential side effects of vaccines. This week, the scientific publication formally retracted the report, saying it contained false information. And Wakefield may lose his license to practice medicine in the U.K. Nevertheless, Wakefield still has a fierce band of defenders who adamantly believes there is a link, despite a mountain of scientific evidence to the contrary. Report

Malaria vaccine proves promising in Mali trial

John Carroll — Thu, 04 Feb 2010 09:43:31 -0500

An experimental malaria vaccine originally developed by GlaxoSmithKline and the U.S. Army has produced dramatic results in an early-stage trial in Mali. Researchers recruited 100 children who are between 1 and 6 years old for the trial and found that the jab provided the same kind of immunity as lifelong exposure to the disease. The children's immune response jumped 100-fold.

"These findings imply that we may have achieved our goal of using a vaccine to reproduce the natural protective immunity that normally takes years of intense exposure to malaria to develop," says Christopher Plowe, professor and chief of the malaria section at the Center for Vaccine Development at the University of Maryland's school of medicine, and a lead author of the study.

"What jumps out to me about this vaccine is the antibody response," Plowe tells Reuters. "When you just look at the antibodies before you immunize anybody, the adults in Mali who have been exposed to malaria life-long, they don't get sick from malaria any more. They get infected but they don't get sick. That is exactly what you want a blood stage vaccine to do."

Their success is leading directly to a larger study that will test the single-strain vaccine in 400 children in Mali. Scientists from the University of Maryland and the Malaria Research and Training Center are conducting the work. The vaccine uses a form of the AMA-1 protein, which was created by the Walter Reed Army Institute of Research and an adjuvant system developed by Glaxo.

- get more info from the Howard Hughes Medical Institute
- here's the AFP report
- here's the story from Reuters

PATH pays FDA for vax development

Liz Jones — Wed, 03 Feb 2010 16:20:20 -0500

The nonprofit group PATH is seeking help from the FDA to develop a vaccine against diseases caused by the Streptococcus pneumoniae bacteria, which kills almost 1 million children each year. And the group is willing to pay $480,000 for the agency's expertise.

The collaborative project, which is expected to run for two years, is being conducted under the Cooperative Research and Development Agreement program. Under the agreement, PATH will help the FDA obtain materials needed for the agency to develop the conjugate vaccine technology. The group then will pay the agency for the development of both the conjugation technology and certain tests, according to an FDA statement.

If the vaccine technology proves successful, the CRADA permits transfer of the technology to the China National Biotec Group's Chengdu Institute of Biological Products, and eventually to groups in other developing countries.

The New York Times notes that while it's unusual for a government agency to be paid by a charity, the work is being done under a law that lets federal laboratories speed outside research in some cases. "The collaboration with PATH is an example of how the FDA applies technologies it develops to public health issues in the United States and throughout the world under the agency's Critical Path Initiative," Karen Midthun, acting director of the FDA's CBER, says.

- read the FDA announcement
- check out the NYT coverage

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Pharma turns to small developers for vax tech

John Carroll — Wed, 03 Feb 2010 15:32:18 -0500

Paul Bogorad at Putnam Associates is bullish about the vaccine business. Reviewing the now familiar story line about Big Pharma's embrace of vaccines after years of neglect, Mass High Tech relates how Bogorad assesses the up-and-coming cadre of small vaccine developers in New England, which is providing much of the new technology that will drive innovation in the field.

Bogorad points out that some independent developers will likely go down the same M&A path as Acambis, which was bought out by Sanofi Pasteur in 2008 for about $548 million. And then MHT shifts to the story of Xcellerex, which provides outsourced manufacturing services as it advances new vaccines in its pipeline. Xcellerex has a Phase I under way for a new yellow fever vaccine.

"Right now, it's a $100 million market," CEO Joe Zakrzewski says of the travel vaccine market. "But 90 percent of the people who need the yellow-fever vaccine don't get it, because the risks of the current vaccine are too high. So we love it when people say the market is small. We think it could be $1 billion."

But vaccine gambles don't always pay off, as Protein Sciences can attest to. The FDA rejected its flu vaccine last fall.

- here's the report from Mass High Tech

Poor nations still waiting for H1N1 vax

John Carroll — Wed, 03 Feb 2010 15:28:32 -0500

When affluent nations scrambled to get in the front of the line last year for the first shipments of swine flu vaccine, the World Health Organization had been hoping to snare a significant portion of the initial vaccine supply for poor nations that couldn't cover the tab for their citizens.

But things didn't work out very well for the poorer countries. Only two out of 95 countries that had pleaded for vaccine supplies--Azerbaijan and Mongolia--have received any. That's far fewer than the 14 countries the WHO had aimed for early on. And now, while a number of wealthy countries are trying to send back unused vaccine, many developing nations are still facing the spread of the virus without a vaccine to defend themselves.

The transfer "turns out to be an incredibly difficult logistical action," Dr. Keiji Fukuda, the WHO's chief of pandemic influenza, tells the New York Times. "It's a mammoth effort by an awful lot of people and organizations and countries but holy-moly, it's a very complex operation."

It's also a dramatic lesson for some vaccine experts.

"If we'd been confronted with H5N1 (the much more lethal avian flu), we'd be completely caught with our pants down," says Dr. David Fedson, a pandemic expert and former medical director for Aventis-Pasteur vaccines. "I don't think any nation got it right."

- here's the article from the New York Times

Rotavirus vax campaign would save millions of lives

John Carroll — Thu, 28 Jan 2010 08:43:04 -0500

Each year, more than half a million children around the world die from rotavirus infection--more than half of them in sub-Saharan Africa. But now two new studies conclude that a widespread vaccination campaign in developing countries could save most of their lives.

Campaigns in Malawi and South Africa reduced the rate of rotavirus infections by 61 percent while another campaign in Mexico eliminated almost two thirds of the deaths caused by diarrheal disease. To effectively protect children, vaccine experts recommend that they get a shot between six and 15 weeks after birth. That can be a tough target to hit in developing countries, where medical care is spotty and supply shipments are irregular. But the study authors say there's no doubt that a vaccination campaign would have a major impact.

"A disease that may be a nuisance in the U.S. can be a killer in a poorer country," says Dr. Kathleen Neuzil, senior author of the African study. "Death from diarrheal disease in general is the second-leading cause of death among kids in developing nations."

- here's the story from HealthDay

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Merck's rotavirus vaccine makes big impact