Workshop Announced on Next-Generation Smallpox Vaccines

The public workshop will take place Sept. 16 in Gaithersburg, Md., and seek to identify key issues in the development and evaluations of these vaccines.

The U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and the National Institute of Allergy and Infectious Diseases will host a public workshop Sept. 16 about the development and evaluation of next-generation smallpox vaccines. It will take place at the Hilton Washington DC North/Gaithersburg in Gaithersburg, Md., and will include presentations on the humans' response to smallpox vaccines and development of animal models for demonstrating vaccines' effectiveness.

The World Health Organization declared smallpox eradicated in 1980, but FDA says the threat of smallpox as a biological weapon remains. First-generation smallpox vaccines were prepared on the skin of calves or other animals or in chicken eggs. "Although these vaccines were not evaluated for efficacy in well-controlled trials, they were highly effective as evidenced by the successful global eradication of smallpox. Manufacturing of these vaccines has ceased and they are no longer licensed in the United States," the agency's notice says. FDA licensed the first second-generation vaccine, ACAM2000, in 2007; it is aseptically propagated using cell culture technology under modern manufacturing practices and standards.

"Because ACAM2000 may cause serious adverse reactions," the notice states, "there is a desire to develop safer vaccines should there be a need to vaccinate the general population due to a threat of an attack with the smallpox virus. Currently, the next-generation smallpox vaccines under development do not produce the characteristic 'vaccine take.' In addition, it is not ethical or feasible to evaluate the effectiveness of these vaccines in humans as the natural disease has been eradicated. Therefore, the effectiveness of these next-generation smallpox vaccines may be based on animal efficacy data, if scientifically appropriate, and to comparative human immune response data. As for any biologic product, licensure of new smallpox vaccines requires demonstration of safety, purity, and potency."

The workshop will discuss regulatory challenges and the strengths and weaknesses of various animal models that can be used to predict effectiveness. About 15 days after the workshop takes place, a transcript of it will be available at

For more information, contact Bernadette Williamson-Taylor at FDA's Center for Biologics Evaluation and Research, 301-827-2000 or e-mail (in the subject line, type "Smallpox Workshop").

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019


      Production vs. Safety 
      Meeting the Requirements for Emergency Equipment
      The State of Contractor Safety
      The Three Keys to Effective Chemical Management
    View This Issue