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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Controversy Over Pricey Malaria Program

Posted: December 18th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , , | Comments Off on Controversy Over Pricey Malaria Program

Health officials have clashed over the effectiveness of a pricey malaria program intended to provide cheap drugs for poor patients. In 2010, the Affordable Medicines Facility for malaria was founded by groups including United Nations agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria, Boston.com reports. The initiative–with a price tag of more than $460 million–was tested in 8 countries. The international charity Oxfam dubbed the program a failure, saying there was no proof it saved lives because officials didn’t track who received drugs and therefore couldn’t conclude whether they reached the right patients. Story

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Stay Away from Those Infected by Mumps, Repeated Exposure Could Overwhelm Your Vaccine

Posted: December 13th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , | Comments Off on Stay Away from Those Infected by Mumps, Repeated Exposure Could Overwhelm Your Vaccine

A recent study shows close, repeated contact with a person with mumps can overwhelm the mumps vaccine.

The study, published in The New England Journal of Medicine, comes after a face-to-face educational technique used among Orthodox Jews apparently led to an outbreak of mumps in 2009 and 2010, despite widespread vaccination, Reuters reports. In a one-year period beginning June 2009, 3,502 cases were reported in New Jersey, New York City and New York’s Orange and Rockland counties. The study examined 1,648 of those cases–almost all in Orthodox Jews–and found 89% had received two doses of the vaccine and 8% received one dose.

Many of the individuals attended a religious school where they practiced an intense training technique called yeshiva. This technique involves close contact with a partner across a narrow table; partners change frequently.

“The risk of infection with mumps may be higher when the exposure dose of virus is large or intensely transmitted,” the report says (as quoted by Reuters).

This prolonged, face-to-face contact apparently overcame the protection the vaccine provided. The study did find high rates of two-dose coverage reduced the severity of the disease and the transmission to people in settings of less exposure. And because the mumps didn’t spread to other communities, it shows the vaccine, in most cases, is effective.

New Flu Vaccine May Not Have to be Given Every Year

Posted: December 11th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: | Comments Off on New Flu Vaccine May Not Have to be Given Every Year

Every flu season, doctors and pharmacists must stock up on the latest influenza vaccine to offer patients. Unlike other vaccines that provide decades worth of protection, the flu vaccine needs to be administered every year. But researchers are looking to change this.

Dr. Sarah Gilbert and her colleagues of Oxford University are working to build a T cell-based vaccine that can attack the part of the flu virus that changes little from year to year. The scientists engineered a virus that can both recognize the proteins from one kind of virus and infect cells but not replicate, the Associated Press reports. This means the infected cells are put on display, but people who receive the vaccine do not grow ill.

“In the history of vaccinology, it’s the only one we update year to year,” Gary J. Nabel, the director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, said (as quoted by the AP). “That’s the goal: Two shots when you’re young, and then boosters later in life. That’s where we’d like to go.”

In a clinical trial of a vaccine that prepares T cells to mount a strong attack against flu viruses, scientists vaccinated 11 subjects and exposed them to the flu. At the same time, they exposed all 11 unvaccinated volunteers. Two vaccinated people became ill, along with 5 unvaccinated ones.

Other researchers are working on vaccines that generate antibodies effective against many flu viruses.

US Awards Contract for Anthrax Vaccine

Posted: December 6th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: | Comments Off on US Awards Contract for Anthrax Vaccine

The U.S. government doled out a contract worth £4 million ($6.4 million) to the U.K.’s Health Protection Agency to develop a next-generation anthrax vaccine. The project will be valued at £14 million ($22.6 million) if all milestones are met.

The U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, provided the contract. HPA will use its expertise in anthrax vaccine antigens with NanoBio‘s adjuvant technology that enables a vaccine to be delivered in fewer doses than are needed currently and sprayed up the nose with an intra-nasal device.

NanoBio, based in Ann Arbor, MI, focuses on developing vaccines based on its technology, dubbed NanoStat. Work on the anthrax vaccine will take place at HPA’s facilities in Porton, Wiltshire in the U.K.

“We are delighted to achieve this award, which is recognition of our world-leading status in the field of anthrax vaccine research and development–we already manufacture anthrax vaccine for the U.K. and our expertise in this area is essential for the success of this program,” Dr. Roger Hinton, principal investigator and head of development and production at HPA Porton, said in a statement.

Anthrax is a bacterial infection caused by the organism Bacillus anthracis. Attempts have been made to weaponize anthrax.

Flu Vaccine Protects from More than Flu

Posted: December 4th, 2012 | Author: | Filed under: Travel Vaccines Updates | Tags: | Comments Off on Flu Vaccine Protects from More than Flu

A new study shows the influenza vaccine protects against more than just the flu–it defends against heart attacks.

Dr. Jacob Udell, a cardiologist at Women’s College Hospital and the University of Toronto, found those who received a flu shot reduced their risk of heart attacks and other serious cardiovascular problems by nearly half during a one-year follow-up period, HealthDay reports. Udell and his team studied more than 3,200 patients from 1994 to 2008. Some people were free of heart disease while others had recently had heart attacks or had stable cardiovascular disease or other coronary problems. Those who received a flu vaccine showed a 50% reduction in heart attack, stroke or other major cardiovascular events.

So how does this work? According to Udell, experts aren’t quite sure. The vaccine may protect vulnerable patients already in poor health from falling more ill. And protection may also result from avoiding the inflammation that goes hand-in-hand with the flu. Either way, Udell said (as quoted by HealthDay), “it certainly lends support to a lot of clinical guidelines that recommend the flu vaccine to patients either with heart disease or after a heart attack.”

Another study showed promising results for patients with implantable cardiac defibrillators. During flu season, those individuals report they get more shocks and need more medical attention than at other times of the year. Cardiologists from Sunnybrook Health Sciences Centre in Toronto completed this study, finding that 11% of those who received the flu vaccine got at least one shock from their defibrillator during flu season. Compare that with the nearly 14% of those who did not receive the vaccine and got a shock from their defibrillator.

Less than 30% of U.S. adults aged 18 to 49 got vaccinated last flu season, according to the U.S. Centers for Disease Control and Prevention.