More Influenza Vaccine Available as Flu Season Approaches

Posted: November 13th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on More Influenza Vaccine Available as Flu Season Approaches

As flu season approaches, vaccines companies are working against the odds to market their influenza vaccines. Last year, the overall U.S. vaccination rate was about 42%–a far cry from the target rates of 80% for people ages 6 months to 65 years and 90% for those older than 65.

Vaccination rates ran the gamut in the 2011-2012 influenza season. For children between 6 months and 23 months, it was 75%, while just over a third of adolescents received the jab, according to the CDC. About 39% of adults were vaccinated, Reuters reports.

This year, a total of 135 million doses of influenza vaccine will be on hand, the nonprofit National Foundation for Infectious Diseases said. As of Sept. 14, more than 85 million doses of the vaccine had been distributed.

“When it comes to flu, we can’t look to the past to predict the future,” Howard Koh, assistant health secretary at the Department of Health and Human Services, said in a news conference, as quoted by Reuters.

FDA green-lighted influenza vaccines from all 6 manufacturers licensed to produce and distribute in the U.S. back in August. This year’s dose includes one strain in common with last year’s and two new ones. But judging by vaccination rates from the previous flu season, the manufactuerers–CSL, GlaxosmithKline, ID Biomedical, AstraZeneca’s MedImmune, Novartis and Sanofi Pasteur–will all be hoping for a change of pace. Factors preventing people from getting the shot include fear that they will get sick from the vaccine, cost and lack of awareness.

Vaccine Demand, Production Increase in India

Posted: November 8th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Vaccine Demand, Production Increase in India

Anticipating a sizable shift in India‘s vaccine industry landscape, a new report estimates that the country’s vaccine production sector will likely expand to an estimated $871 million by 2016. Compare that with 2011’s value of $350 million.

Global Business Intelligence Research forecasts the Indian vaccine market will grow 20% a year for the next four years. New research into cancer vaccines and fears of bioterrorism and severe acute respiratory syndrome (SARS) are sparking the rise in production.

In recent years, Indiahas emerged as a major vaccine producer, aiming efforts on geographical regions where vaccines are not funded by the United Nations or charitable organizations. Such a focus meant exports made up 65% of the Indian vaccines market last year.

Malaria Vaccine Development Advances

Posted: November 6th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , | Comments Off on Malaria Vaccine Development Advances

GenVec inked a $3.5 million agreement with the Naval Medical Research Center o support malaria vaccine development.

The Gaithersburg, MD-based company will produce supplies of its vaccine for use in clinical trials.  The company retains the right to commercialize the product.  The NMRC will assess the safety and efficacy of the vaccines in a clinical challenge model it developed with Walter Reed Army Institute of Research malaria vaccine programs.  Those programs are now unified as the U.S. Military Vaccine Program.

NMRC and WRAIR tested out GenVec’s candidate in April 2010 in a Phase I trial.  The data from the trial indicated the vaccine is safe, “causing minimal local or systemic reactions and no serious vaccine-related adverse reactions,” according to GenVec’s statement.  And four out of 15 volunteers inoculated with the vaccine showed a complete absence of parasites in the blood.

New Vaccine Shows Good Results in Testing

Posted: November 1st, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , | Comments Off on New Vaccine Shows Good Results in Testing

Pfizer posted positive results in a late-stage study of its Prevnar 13 vaccine. The study of the shot, known as Prevnar in the U.S. and Prevenar in other countries and used to prevent infection by streptococcus pneumonia, showed that the immune response to the vaccine in the 18- to 49-year-old age group was noninferior when compared to the response in the 60- to 64-year-old age group.

The objective was met for all 13 serotypes in Prevnar 13, and the data support a recent regulatory submission to expand the indication of Prevnar 13 in the EU to include adults between 18 and 49 years old. Pfizer will also use study results to support similar planned submissions in other countries.

“Prevenar 13 is the first and only pneumococcal conjugate vaccine for adults, and we continue to study the vaccine in new populations with the aim of broadening its availability,” William Gruber, senior vice president of Vaccine Clinical Research and Development at Pfizer, said in a release.

The positive results come less than a month after the World Health Organization granted prequalification for the vaccine in adults over the age of 50, a decision that expanded the global market for the company’s lead vaccine.

Prevnar 13 is already approved in 110 countries for infants and young children. But only about 70 countries, including the U.S., approve it for adults over 50.

Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

Posted: October 30th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , | Comments Off on Corporate-Non Profit Partnership Developing Tuberculosis Vaccine

GlaxoSmithKline will work with nonprofit biotech Aeras to test a tuberculosis vaccine in Africa and India, making headway in developing new ways to prevent the disease.

After promising early-stage clinical trials of GSK’s TB vaccine candidate, the partners will conduct a Phase IIb trial in Kenya, Indiaand South Africa next year pending approvals from authorities. Both GSK and Aeras will provide resources to test the vaccine candidate in healthy adults between ages 18 and 50.

“When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for R&D remains critically low in this area,” Jim Connolly, president and CEO of Aeras, said in a release. “Working in partnership with GSK–sharing resources, capabilities and know-how–affords us the opportunity to conduct this pivotal, multicountry proof-of-concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”

The TB vaccine Bacille Calmette-Guerin (BCG) prevents some forms of the disease, but not pulmonary TB–and that’s the one responsible for the majority of infections and deaths. GSK and Aeras plan to use their candidate in conjunction with BCG.

New Attempt to Create Staph Vaccine Begins

Posted: October 25th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , | Comments Off on New Attempt to Create Staph Vaccine Begins

Pfizer, GlaxoSmithKline and NovaDigm Therapeutics are each in search of a vaccine to stop methicillin-resistant Staphylococcus aureus, a staph infection that kills more people in the U.S. than skin cancer, Bloomberg reports.

The drugmakers take up the task after two other companies failed to make an effective vaccine–most recently Merck in 2011.  The staph infection can cost as much as $8 billion a year to treat.

“It’s very clear we need a vaccine, and we need it soon,” Robert Daum, a pediatrics professor at the University of Chicago and principal investigator at the school’s MRSA Research Center, told Bloomberg.  “The challenge is, we don’t really know what makes people immune to staph infections.”

The vaccines from the three companies are in early stages in the pipeline, working through the first of three phases typically required for market approval. Pfizer has two vaccines in early trials, while GSK has completed its first-stage trial of a four-component vaccine. NovaDigm completed two Phase I trials that showed its therapy, NDV-3, is safe in humans.

Generally, benign Staphylococcus aureus bacteria live on people’s skin and in their nasal passageways, Bloomberg reports.  The bacteria can enter the skin through cuts, sores, catheters and breathing tubes, making infection common in hospitals and nursing homes. MRSA kills more than 11,400 Americans a year.

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Cancer Vaccines Advance to Phase IIb

Posted: October 23rd, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , , , , | Comments Off on Cancer Vaccines Advance to Phase IIb

CureVac, a biotech company pushing therapeutic cancer vaccinesinto Phase IIb studies, landed a cool $104 million from German multibillionaire Dietmar Hopp’s investment group, Dievini Hopp BioTech Holding.

Image representing CureVac as depicted in Crun...

Image via CrunchBase

Image representing dievini Hopp Biotech Holdin...

Image via CrunchBase

CureVac will use the hefty sum to advance the development of its two lead RNActive cancer vaccines against prostate cancer and non-small cell lung cancer.  The company will also use some of the funds to further develop its prophylactic vaccines and adjuvants for infectious diseases.  The first task will be to run a Phase IIb study on prostate cancer vaccine CV9103, CureVac CEO Ingmar Hoerr told FierceBiotech.

To date, CureVac has raked in about €145 million ($189 million) in equity financing.

“Our technology is based on a major new understanding of the medical potential of mRNA, and our novel mRNA vaccines and RNA-based adjuvants may transform the treatment of many debilitating diseases, including prostate and lung cancer, as well as the prophylaxis of many infectious diseases,” Hoerr said.

Last September, CureVac and Sanofi Pasteur inked a deal to develop and apply the RNActive technology platform to the development of vaccines against several infectious diseases.  In another deal, the two companies–along with France’s In Cell Art–undertook a $33 million DARPA research program to identify and create a universal vaccine technology platform for infectious diseases.

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West Nile Virus on the Rise

Posted: October 18th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on West Nile Virus on the Rise

West Nile virusis on the rise in the U.S.  The Centers for Disease Control and Prevention is reporting the most cases since the virus was first detected in the country in 1999.

West Nile Virus Cases in the United States

West Nile Virus Cases in the United States (Photo credit: Wikipedia)

A total of 1,118 cases and 41 deaths were reported to the CDC as of the third week in August. And 75% of the cases come from 5 states: Texas, Mississippi, Louisiana, Oklahoma and South Dakota.  The numbers are trending upward.

Experts say they don’t know why the outbreak is worse this year than in years past, but hot weather does seem to promote the outbreak.

“Hot weather, we know, from experiments done in the laboratory, can increase the transmissibility of the virus through mosquitoes and that could be one contributing factor,” Lyle Petersen, director of the division of vector-borne infectious diseases at the CDC, said in a news briefing.

Texas has seen nearly half the cases of West Nile, a statistic that prompted the CDC to provide more than $2.5 million to support increased surveillance control including spraying. Two CDC teams went to the state to support local healthcare officials, too.

There’s no vaccine for the West Nile virus, but companies are working toward solutions.

Flu Vaccine is Safe for Pregnant Women

Posted: October 16th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Flu Vaccine is Safe for Pregnant Women

A new study concludes that the flu vaccine is safe for pregnant women, even in the first trimester. The study consisted of nearly 9,000 pregnant women who received the vaccine. And the rate of birth defects was the same from women who got vaccinated and those who did not, Reutersreports.

A pregnant woman

A pregnant woman (Photo credit: Wikipedia)

Though doctors recommend that pregnant women receive a flu shot, because they are more likely than other women their age to get a severe case of the flu or have complications, most in the United Statesdo not, according to Reuters. A mere 10% to 25% of women got vaccinated each flu season over the past couple decades, said Jeanne Sheffield, a professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas. This means there’s a market out there that flu vaccine makers are missing.

“The flu is a problem in pregnancy,”Sheffieldsaid. “But we have a vaccine to prevent it. And it’s considered safe and effective in any trimester.”

Earlier this month, the FDA approved 6 flu vaccines from companies licensed to distribute the products in the United States.

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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