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

Animal Rule information, including product approval announcements
BioThrax information from FDA, including product history and labeling
About anthrax, from CDC

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

Register now - registration will close on December 11, 2015, or when the event reaches capacity
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More about PHEMCE - Public Health Emergency Medical Countermeasures Enterprise

News updates

More events:

December 2, 2015: Workshop - Clinical Trials: Assessing Safety and Efficacy for a Diverse Population, hosted by FDA and the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) (Silver Spring, MD and webcast)

February 3, 2015: Eighth Annual Sentinel Initiative Public Workshop - registration required (Washington, DC and webcast) - more about the Sentinel Initiative

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.

Draft Guidance for Industry - Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF, 113 KB) - comment by December 21, 2015 (Federal Register notice)

How to submit comments

Funding opportunities and other deadline reminders:

FDA's Center for Devices and Radiological Health (CDRH) invites medical device industry, academia, and health care facilities to request to participate in the 2015 Experiential Learning Program, a training program for FDA's medical device review staff. Submit requests for participation by December 16, 2015.

FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects

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)