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.

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.

Stronger Influenza Vaccines Needed

Posted: November 22nd, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Stronger Influenza Vaccines Needed

Researchers at the University of Minnesota’s Center for Infectious Disease Research and Policy claim current influenza vaccines offer less protection against the infectious disease than previously thought, and better ones are necessary.

A report titled “The Compelling Need for Game-Changing Influenza Vaccines” says the U.S.-licensed trivalent inactivated influenza vaccine does not differ widely from the one first developed in 1968. And a live-attenuated influenza vaccine licensed in 2003 is made using techniques from the 1930s, Fox reports.

So why hasn’t a new flu vaccine come along? The financial risks and inadequate incentives throw up roadblocks for most biotechs that might otherwise show interest. The entire process–from preclinical research through licensure–can take up to 15 years and cost more than $1 billion, the report says. A novel flu vaccine providing protection over the course of several years will need to cost more per dose than current vaccines for investors and manufacturers to realize the financial benefit of the endeavor.

And many believe the current flu vaccines offer enough protection. “A major barrier to the development of game-changing influenza vaccines is the perception that current vaccines are already highly effective in preventing influenza infection,” the report says.

Currently, 6 companies are licensed to produce and distribute flu vaccines in the U.S.: CSL, GlaxoSmithKline ($GSK), ID Biomedical, AstraZeneca’s MedImmune, Novartis  and Sanofi Pasteur. This year, a total of 135 million doses of influenza vaccine will be on hand. Each year, between 3,000 and 49,000 Americans die from seasonal influenza.

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 Manufacturer Receives Clean Bill of Health from FDA

Posted: October 9th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Vaccine Manufacturer Receives Clean Bill of Health from FDA

After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, snagging a closeout letter from the FDA.


FDA (Photo credit: Wikipedia)

The FDA slapped the company with a warning letter in June 2011, questioning CSL’s manufacturing quality.  Its processes may have contributed to issues with a flu vaccine and led to the hospitalization of several children in 2010.  Australian regulators put a halt to licensing Fluvax for children under age 5 at the time.

CSL’s missteps included failing to adequately investigate dark particles found in some vials and completing only a limited analysis of the manufacturing process to determine why the adverse events shot up in 2010 compared with previous seasons.  “There was no analysis of all critical parameters and critical processing steps to determine differences in the 2010 lots associated with adverse events reports compared to lots from previous seasons,” the warning letter says.

As for the dark particles, the FDA investigation focused on multidose vials only.  Analysis of the particles showed that they were “discolored influenza virus with the possible presence of mercury compounds,” according to the warning letter.  The company refuted this, saying the dark particles were not foreign to the product.  The FDA disagreed.

The closeout letter comes a few weeks after CSL announced that the company’s CEO, Brian McNamee, will step down next July.  He’ll be replaced by the current president of CSL Behring, Paul Perreault.