martes, 1 de diciembre de 2015

First Animal Rule vaccine approval

FDA Medical Countermeasures Initiative Update

FDA approves vaccine for use after known or suspected anthrax exposure

First vaccine to receive approval under the Animal Rule

Scanning electron micrograph showing spores from the Sterne strain of Bacillus anthracis bacteria. (Credit: CDC/Laura Rose)FDA has approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible.
Read the FDA press release 

Related information

Image: Scanning electron micrograph (SEM) showing spores from the Sterne strain of Bacillus anthracis bacteria. A key characteristic of the Sterne strain of B. anthracis is the wrinkled surface of the protein coat of these bacterial spores. (Credit: CDC/Laura Rose)

PHEMCE Stakeholders Workshop

January 6-7, 2016
This two-day workshop will highlight past progress and future directions in developing, stockpiling and effectively utilizing the drugs, vaccines, and devices that may be required in public health emergencies caused by either naturally occurring epidemics or intentional chemical, biological, radiological and nuclear attacks.

Related information

News updates

More events:
View more events on the frequently updated MCMi News and Events page
Guidance and information for industry:
  • Last chance! FDA announced a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Submit requests to participate in the REMS SPL pilot by December 7, 2015
Funding opportunities and other deadline reminders:
In case you missed it:
  • FDA approves first seasonal influenza vaccine containing an adjuvant - FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. (November 24, 2015)

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