HEALTH

Record-breaking influenza season nears end

BY Michael Johnsen

For the week ended March 17, influenza activity in the United States continued to decrease, though the season is still not over, according to the latest FluView report from the Centers for Disease Control and Prevention. ILI dropped from 3.2% reported last week to 2.7%. When that illness rate metric falls below the national baseline of 2.2%, that will indicate the end of the season.

So this week may be the last week of what has been a record-breaking flu season.

However, 17 states continue to report widespread flu activity, meaning ILI activity has been reported at centers across at least half of the state, and six states still are reporting high influenza-like illness levels. Those six states are located across the continent, including Arizona and Wyoming in the West, Nebraska and South Dakota in the Midwest and South Carolina and Virginia in the South.

Nine states are experiencing moderate ILI activity.

Hospitalization rates are higher than the end-of-season hospitalization rates for 2014-2015, a high severity, H3N2-predominant season. CDC also is reporting an additional five flu-related pediatric deaths during week 11, bringing the total number of flu-related pediatric deaths this season to 133.

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NIH: Advanced vaccine technology will limit future outbreaks

BY Michael Johnsen

Scientists at the National Institute of Allergy and Infectious Diseases are working toward the development of a novel vaccine technology in an effort to improve any public health response to infectious disease threats. In a recent perspective in The Journal of the American Medical Association, the experts highlighted innovations that could significantly shorten the typical decades-long vaccine development timeline.

NIAID is part of the National Institutes of Health.

Historically, vaccines against viral diseases have used live-attenuated (weakened) viruses or inactivated whole viruses to induce protective immune responses. The development process often takes as many as 20 years or more and requires virus cultivation, animal model testing, product formulation, immunogenicity testing and years of costly clinical trials.

However, substantial technological advances of the past decade, such as synthetic vaccinology and platform manufacturing, have helped expedite the process and shorten manufacturing time, allowing clinical evaluation to begin sooner, according to the authors. Synthetic vaccinology uses information from viral gene sequencing to create DNA and mRNA molecules encoding viral proteins.

Because advancements in vaccine technology does not require replicating “live” viruses, it does not need to be done in high-level containment facilities when developing vaccines for highly pathogenic viruses.

Once a vaccine platform is established, such as that for DNA or mRNA vaccines, potentially it can be applied to multiple pathogens, especially within virus classes or families. For example, NIAID’s Vaccine Research Center quickly developed a candidate DNA vaccine for Zika virus with the same platform used previously for a related flavivirus, West Nile virus.

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CRN files amicus brief in support of the VMS status of fish oil

BY Michael Johnsen

The Council for Responsible Nutrition and the Global Organization for EPA and DHA Omega-3s on Friday joined forces against an attempt by Amarin Pharma to classify concentrated EPA omega-3 fish oil supplements as pharmaceuticals.

“From the start, CRN recognized that Amarin’s intentions were iniquitous,” Steve Mister, president and CEO, CRN, said. “They sought to create a market monopoly over a subset of omega-3 products, which would directly hinder legitimate manufacturers from selling fish oil supplements. CRN is committed to fight for its member companies in this space and ensure responsible industry can continue to do business without the burdensome restrictions Amarin seeks to impose. Further, inhibiting consumers’ ability to obtain concentrated omega-3 supplements without a prescription deprives consumers of the health benefits those supplements can provide.”

Omega-3 fatty acid supplements are consumed by 16% of U.S. adults according to a recent survey by CRN.

CRN joined GOED in submitting an amicus brief Friday to the United States Court of Appeals for the Federal Circuit, addressing an appeal made by Amarin Pharma protesting the International Trade Commission’s decision not to review reclassifying the prescription status of fish oil supplements.

Amarin last year asked the ITC to declare concentrated EPA to be a drug and to prohibit its importation for use in supplements, a move which CRN previously warned would “dramatically affect consumers’ access by making it more difficult and expensive, if not impossible, to obtain the health benefits associated with these products.”

In the brief, CRN and GOED defended ITC’s decision to dismiss Amarin’s complaint, as Amarin’s requested relief would require ITC to inject itself into the statutory and regulatory framework explicitly authorized to the Food and Drug Administration. Because Amarin “did not, and could not, allege that the concentrated fish-oil products accused were not, in fact, dietary supplements under any objective standard or ruling,” CRN noted that the complaint failed to satisfy the requirements of the statute and ITC’s rules governing complaints. “Market participants have significant reason to believe that the current practice of labeling concentrated omega-3 products as ‘dietary supplements’ is proper,” wrote CRN, maintaining that companies marketing these products are in no way violating the Food, Drug & Cosmetic Act, as Amarin claimed they were.

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