Friday, July 24, 2009

Vaccine Development, Targeting, and Use of Unapproved Products

This HHS chart indicates that vaccine will be distributed in early November, after which "monitoring effectiveness and safety" begins.

Here is an excellent H1N1 swine flu links page from the National Library of Medicine.

This DHHS/DHS document explains the plan for priority targeting of (pandemic) influenza vaccinations.

According to FDA:

Through an Emergency Use Authorization (EUA), the Project BioShield Act of 2004 gives FDA authority to make promising drugs, biologics, and devices quickly available in emergencies.

This Act allows FDA, based on an evaluation of available data, to

  • authorize the emergency use of unapproved or uncleared medical products
  • authorize the unapproved or uncleared use of approved or cleared medical products

The authorization may remain in effect for the duration of the declaration justifying the emergency use (up to one year). The declaration may be terminated prior to one year or renewed at the end of one year. FDA can revoke an EUA if, for example, the criteria for issuance are no longer met.

Soon after HHS declared a nationwide public health emergency on April 26, 2009, FDA issued authorizations for the emergency use of certain influenza medicines, diagnostic tests, and certain personal respiratory protection devices.

No comments: