HEALTH

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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GSK, RB no longer in running for Pfizer Consumer business

BY Michael Johnsen

GlaxoSmithKline on Friday confirmed it has withdrawn from the bidding war for the Pfizer Consumer Healthcare business, following a similar announcement made by RB earlier this week.

That doesn’t leave many companies large enough to swing the reported asking price of $20 billion for an OTC portfolio that includes powerhouse brands Advil and Centrum. Johnson & Johnson dropped out of the running in January.

“While we will continue to review opportunities that may accelerate our strategy, they must meet our criteria for returns and not compromise our priorities for capital allocation,” Emma Walmsley, CEO GSK, said.

RB released a similar statement earlier in the week. “Our priority remains organic growth, including the completion of the integration of Mead Johnson Nutrition and creating further value from reorganizing into two new business units – Health and Hygeine Home,” Rakesh Kapoor, RB CEO, said. “We always approach inorganic growth opportunities in a rigorous, disciplined and financially responsible manner to ensure long-term value creation for shareholders. An acquisition for the whole Pfizer consumer health business did not fit our acquisition criteria and an acquisition of part of the business was not possible.”

GlaxoSmithKline may have been souring to the possible acquisition of the Pfizer consumer business as early as February, when Walmsley reported GSK was looking at the deal, but not at the expense of the company’s focus on pharma.

 

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