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New Hepatitis Vaccine May Soon Be Available

Posted: January 3rd, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , | Comments Off on New Hepatitis Vaccine May Soon Be Available

California’s Dynavax Technologies scored a win when FDA staff said the company’s Heplisav vaccine works against the contagious liver disease hepatitis B.

The FDA said in a report that Heplisav worked as well after two doses as three doses of GlaxoSmithKline’s Engerix-B vaccine. The vaccine also had a similar safety profile to Engerix-B.

Company stock rose 13% upon the news, closing Tuesday at $4.74. This marks the largest single-day jump since September 2011.

Dynavax does not yet have a product on the market, so Heplisav will be first should the FDA approve the vaccine Feb. 24, when the organization is scheduled to make a decision. The product could rake in an estimated $775 million in worldwide sales come 2020, Katherine Xu, an analyst with William Blair & Co., told Bloomberg.

In a study of about 2,400 patients ages 18 to 55, 95% of those who took two doses of Heplisav were protected from hepatitis B. By comparison, 81% of those who took three doses of Glaxo’s Engerix-B were protected.

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Potential New Malaria Vaccine Tests Poorly

Posted: January 1st, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , | Comments Off on Potential New Malaria Vaccine Tests Poorly

A GlaxoSmithKline malaria vaccine posted surprisingly lackluster results in a Phase III trial, putting a damper on solid results from previous studies. The vaccine against the mosquito-borne illness proved only 30% effective when given to African children in a clinical trial.

Still, GSK plans to move forward with development of the vaccine. The trial included 6,537 babies aged 6 to 12 weeks; the vaccine offered “modest protection,” knocking down episodes of the disease 30% compared with the immunization with a control vaccine.

“The efficacy is lower than what we saw last year with the older 5-17 month age category, which surprised some of us scientists at the African trial sites,” Dr. Salim Abdulla, a principal investigator for the trial from the Ifakara Health Institute in Tanzania, said in a release. “It makes us even more eager to gather and analyze more data from the trial to determine what factors might influence efficacy against malaria and to better understand the potential of RTS,S in our battle against this devastating disease.”

In 2010, malaria caused an estimated 655,000 deaths, mostly among African children, the World Health Organization says.

The Phase III trial, completed in conjunction with PATH Malaria Vaccine Initiative, was backed by $200 million from the Bill & Melinda Gates Foundation. Bill Gates, whose organization commits billions of dollars to improving global health, said the study marked an important milestone.

“The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do,” Gates said in a statement. “The trial is continuing and we look forward to getting more data to help determine whether and how to deploy this vaccine.”

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Flu Vaccination Rates Disappointing

Posted: December 27th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , , | Comments Off on Flu Vaccination Rates Disappointing

Every flu season is different. Strains evolve and influenza vaccine manufacturers alter their formulas to meet those changes, covering the three influenza viruses that research indicates will be most prevalent during a given season.

But despite the wide availability of a vaccine–the U.S. FDA green-lighted influenza vaccines from 6 vaccine manufacturers this year–the illness remains a killer. Between 1976 and 2007, estimates of the number of flu-associated deaths range from 3,000 to 49,000, the Centers for Disease Control reports. About 90% of those deaths happened among people ages 65 and older.  

Further, vaccination rates last year fell far below the CDC’s target rates of 80%, coming in at around 42%. About 39% of adults were vaccinated during the 2011-2012 influenza season, compared with 75% of children between the ages of 6 months and 23 months and just more than a third of adolescents.

This year, a total of 135 million doses of influenza vaccine will be on hand.

So, what do these less-than-stellar vaccination rates mean for sales? Looking at actual worldwide 2011 sales numbers and estimated worldwide 2012 sales numbers provided by EvaluatePharma, it seems sales as a whole are only slightly up for the top 10 best-selling flu vaccines.

Novartis will likely see the biggest jump in sales of its OptaFlu vaccine; the company reported $36 million in 2011 sales and EvaluatePharma projects $71 million in 2012 sales. Sanofi’s and Sanofi Pasteur MSD’s Fluzone (sold as Vaxigrip outside the U.S.) will likely bring a $10 million jump in sales, from $1.333 billion in 2011 to a projected $1.343 billion this year.

The outlook isn’t all promising for the top 10, though. Abbott Laboratories’ Influvac will probably see a $10 million drop, from $198 million in 2011 sales to an estimated $188 million in 2012. Mitsubishi Tanabe Pharma’s BIKEN HA vaccine will also lose out, slumping by $6 million from $114 million in 2011 sales to a projected $108 million in 2012.

“The changing world demographic provides a definite opportunity for companies offering flu vaccines, as populations age and chronic conditions become more prevalent,” Moser said. “With this trend towards an older, less healthy population, demand should continue to increase for flu vaccines for the foreseeable future, with a non-specific vaccine that can protect against ever-evolving influenza strains being the holy grail in this space.”

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Merry Christmas and Potential New Vaccine Against Meth Addiction

Posted: December 25th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: , , | Comments Off on Merry Christmas and Potential New Vaccine Against Meth Addiction

A team of scientists at the Scripps Research Institute saw promising results in a study of a vaccine against methamphetamine. With more than 430,000 users nationwide, methamphetamine has become one of the most common recreational drugs in the U.S.

The early-stage study, released in the journal Biological Psychiatry, showed that the vaccine protected against meth intoxication in laboratory animals. The compound MH6 blocked two effects of meth in rats given the drug: high energy levels and increased body temperature. This may indicate that the vaccine was preventing methamphetamine from reaching the nervous system.

A healthy antibody response in rats given MH6 also led scientists to believe the body was fighting the drug.

“This is an early-stage study, but its results are comparable to those for other drug vaccines that have gone to clinical trials,” Michael Taffe, a Scripps researcher with the institute’s Committee on the Neurobiology of Addictive Disorders, told California Watch. “It looks promising, but we’re still early on in the process.”

Unfortunately, effects of the vaccine last only weeks, not years. But research is still in its infancy.

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Progress in the Quest for an AIDS Vaccine

Posted: December 20th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , | Comments Off on Progress in the Quest for an AIDS Vaccine

Good news out of Canada in the search for an HIV vaccine: Scientists announced a vaccine candidate showed no adverse effects and significantly boosted immunity in human trials.

Researchers from the Schulich School of Medicine & Dentistry at Western University in Ontario are working on a vaccine dubbed SAV001-H, the only HIV vaccine being developed in Canada. The vaccine, approved by the FDA for clinical trials last year, uses a killed whole HIV-1 virus to spark an immune response. The same strategy was used to develop influenza, polio, rabies and hepatitis A vaccines.

In the Phase I study, HIV-positive men and women aged 18 to 50 were split into two groups, with 18 people receiving the vaccine and 6 getting a placebo.

“There were no adverse effects,” Dr. Chil-Yong Kang, professor of virology at the Schulich School of Medicine & Dentistry, told the Toronto Star. “And after the vaccination, the level of (HIV-1) antibodies increased significantly. That means our vaccine is working to stimulate the immune responses.”

In one individual, researchers saw a thirty-twofold increase in the level of HIV-1 antibodies. Another showed a tenfold increase.

Now, researchers will move on to Phase II, a study slated to begin next year. This yearlong study will test the vaccine on 600 HIV-negative volunteers at high risk for infection so researchers can gauge immune response.

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Vaccines Get Stronger

Posted: October 11th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements, Uncategorized | Tags: , , , , | Comments Off on Vaccines Get Stronger

Researchers at Oxford University discovered a compound that gives vaccines a little extra might in the fight against viruses such as the flu, HIV and herpesin mice.

None - This image is in the public domain and ...

(Photo credit: Wikipedia)

Mice given a dose of the flu shot that included the polymer, polyethyleneimine (PEI), were protected fully against a lethal dose of the flu.  Formulas without the adjuvant or with different adjuvants didn’t show nearly as positive results.  The Oxford scientists, working with U.S. and Swedish researchers, will soon test the PEI adjuvant on ferrets.

“Gaining complete protection against flu from just one immunization is pretty unheard of, even in a study in mice,” said professor Quentin Sattentau of the Dunn School of Pathology at Oxford University, who led the work.  “This gives us confidence that PEI has the potential to be a potent adjuvant for vaccines against viruses like flu or HIV, though there are many steps ahead if it is ever to be used in humans.”

The most popular adjuvant is alum, an aluminum-based compound. But it’s not the most potent.  However, mice showed a powerful immune response when PEI was included in a vaccine with a protein from HIV, flu or herpes virus.  PEI works well as an adjuvant for mucosal vaccines, those absorbed through the nose or mouth.  This is good news for those who dread needles.

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Painless Flu Vaccines

Posted: October 2nd, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on Painless Flu Vaccines

Five years ago this summer, AstraZeneca decided to pony up to purchase Maryland-based MedImmune for a cool $15.6 billion, a deal that left many wondering whether the bills matched the product.  Now, incoming CEO Pascal Soriot has his work cut out for him.

Come October, the French-native will jump over from Roche , where he served as chief operating officer since 2010. He’s inheriting a vaccines and biotech drugs division with 2,600 Maryland employees and 4,000 globally, The Washington Post reports.  The company will also shutter two California offices, leading to a loss of 200 jobs and a shift of 100 more to other sites.

MedImmune has had its ups and downs, with the vaccines business supplying some upbeat results; in 2009, the company was the first to market a swine flu vaccine.  And this year MedImmune rolled out the first intranasal flu vaccine that contains four strains of the disease.

English: Millington, Tenn. (Oct. 28, 2005) &nd...

(Photo credit: Wikipedia)

Fluenz nasal spray became the vaccine of choice in the U.K. for children ages 2 to 17 in a contract expected to exceed £100 million ($156.7 million).  The company’s FluMist brought in $161 million of AZ’s $33.6 billion in revenue in 2011.


Breakthrough in the Search for a Malaria Vaccine

Posted: September 20th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , , , , | Comments Off on Breakthrough in the Search for a Malaria Vaccine

Researchers atAustralia’s Burnet Institute discovered a prime target in the immune system’s battle against malaria, marking a turning point in the search for a vaccine.

Malaria distribution map. Most countries with ...

Malaria distribution map. Most countries with a high distribution of malaria also have a high distribution of parasitic worm infections. (Photo credit: Wikipedia)

Studies show people immune to the disease develop antibodies that home in on a protein known as PfEMP1, produced by Plasmodium falciparum, the organism behind most cases of malaria, according to Medical Xpress. The findings prove valuable in determining for which malaria proteins–known as variant surface antigens–a vaccine should aim. The study also showed that when the immune system takes action against other proteins produced by malaria, it does not effectively protect the body, further underscoring the need for a vaccine to seek out the appropriate target.

“The new findings support the idea that a vaccine could be developed that stimulates the immune system so that it specifically mounts a strong response (or attack) against the PfEMP1 protein that malaria produces,” James Beeson, senior author of the study, tells Medical Xpress.

More than 40% of the world’s population live in areas where there is a risk of contracting the mosquito-borne illness, which will make developing a vaccine both profitable to the manufacturer and beneficial to world health. Nearly 1 million individuals die of malaria each year, according to the NIH.


Finally! A Vaccine for Allergy Relief

Posted: September 18th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , | Comments Off on Finally! A Vaccine for Allergy Relief

Allergy Therapeutics will court a partner to market its Pollinex Quattro Grass vaccine now that the FDA lifted a clinical hold on the grass pollen allergy shot.

The company can move forward with a Phase III efficacy study, which will take place in an environmental exposure chamber, according to a release. The vaccine–commercialized in some European countries–comes as a four-shot series, requiring the injections over the course of a year.

Vaccines research at the NVGH

Vaccines research at the NVGH (Photo credit: Novartis AG)

The FDA froze the vaccine in 2007, after a volunteer experienced numbness and weakness during a trial. Allergy Therapeutics’ stock tumbled 22% at the time, according to FierceBiotech. But the U.K.-based company’s shares jumped almost 30% after the FDA lifted the hold.

“This product has the potential to greatly benefit allergy sufferers in the U.S.in the absence of registered products by being the first subcutaneous immunotherapy vaccine to reach the U.S.market,” said CEO Manuel Llobet. “Additionally, lifting the hold will allow for discussions with potential partners with whom we will finalize the clinical development and start the commercialization of Pollinex Quattro in a market estimated to be around $2 billion.”


Vaccine Company Fights Antitrust Allegations

Posted: September 13th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , , | Comments Off on Vaccine Company Fights Antitrust Allegations

Sanofi Pasteur may find itself in the thick of an antitrust case after a judge ruled that a lawsuit alleging that the company illegally monopolized the market for meningococcal vaccines in theU.S. can move forward.

Sanofi

Sanofi (Photo credit: Wikipedia)

In December, several doctors said the company created a “web of noncompetitive contracts” with physician buying groups that blocked competition in an effort to sell its vaccine MenactraPharmalot reports. Using its market authority, Sanofi grouped price contracts, forcing purchasers to buy 90% or more of childhood vaccines to avoid potential cost penalties on Menactra, according to the news service. So, in theory, a buyer could end up paying 15% to 35% more for all Sanofi vaccines if they elect not to buy Menactra. The doctors surmise Sanofi’s idea here was to promote its Menactra vaccine after Novartis ($NVS) joined the game with rival Menveo.

Furthermore, the lawsuit says the doctors were told, under contract, not to purchase vaccines from other makers–such as GlaxoSmithKline ($GSK) and Novartis–or they would face penalties.

A Sanofi Pasteur spokesman wrote to Pharmalot, “naturally we are disappointed in the judge’s ruling, but we are confident that once the court sees the evidence of competition in the marketplace, it will rule against the plaintiffs. We continue to defend our company and our product, and we maintain that allegations in the class action complaint are without merit.”