According to the USDA Center for Veterinary Biologics, Draft Notice 24-13, protocols are solicited for field evaluation of H5N1 vaccine.  In a change of policy regarding administration of H5 vaccines the Center for Veterinary Biologics has imposed the following requirements:-

• USDA intends to regulate distribution and use of H5 vaccines in the U.S.

• Vaccines should be inactivated and hence non-viable and non-replicating.

• Appropriate records relating to manufacture and distribution of vaccines will be required.

• Conditional licensure can be granted for vaccines for lactating dairy cattle based on a “reasonable expectation of efficacy and safety”.

• Studies intended to demonstrate the efficacy of a vaccine should follow Title 9 Code of Federal Regulations Part 103.3 that requires state approval.

• Proposals relating to field evaluations should include procedures for sampling milk and serology for vaccinated animals with relevant controls.

• Appropriate records relating to the disposition of vaccinated cattle are mandated.

• Approval by an accredited veterinarian will be required to move cattle to slaughter for a period of two years following vaccination.

The USDA Draft Notice does not consider other than inactivated vaccines.  It is anticipated that live attenuated and alternative products including vectored subunit and mRNA vaccines will eventually be evaluated as they become available but most likely restricted to biocontainment facilities.