Avian Metapneumovirus Questions and Answers
The notice allows CVB to use a risk-based approach to meet an emergent need in the field. For the first time, CVB is authorizing the use of experimental autogenous vaccine (inactivated) to expedite product availability. The CVB is allowing import of Master Seed (aMPV virus) and Master Cell Stock (cells) for domestic production of live products to speed manufacturing. CVB will perform concurrent testing of Master Seeds and Master Cell Stocks to save time on product availability. May also provide some flexibility on using some existing data to speed up the licensure process.
Manufacturers are both producing experimental autogenous vaccine and have been granted import permits for killed vaccines. The names of the manufacturers are considered confidential business information (CBI) and CVB cannot reveal the manufacturers. Stakeholders are encouraged to reach out to manufacturers with questions.
Historically, CVB has not allowed import of live vaccines due to the risk, especially for poultry. CVB performed limited purity and safety testing of the first serial for Avian Metapneumovirus for modified live viral vaccines to determine eligibility for importation as part of the risk assessment. Based on the satisfactory CVB testing and risk assessment, CVB has issued several permits.
CVB is facilitating import for aMPV diagnostic test kits.
Reporting to APHIS is voluntary so APHIS does not have the full U.S. data.
A Research and Evaluation (R&E) permit issued under emergency authorization to meet an emergent need in the field is generally valid for one year and may cover multiple imports. R&E permits may be renewed until the product is no longer needed such as if a license is issued for a killed product. CVB has issued import permits for multiple inactivated aMPV vaccines and can reissue permits or grant new permits as the need in the field is assessed and warranted.
CVB will evaluate the field need and supply situation then determine a time period for conditionally licensed products to remain on the market while they complete the requirements for full licensure. Regulatory flexibility will be extended as needed.
Yes, multiple strains of aMPV may be used in the experimental autogenous product for distribution.
Countries with reference to aMPV on current live animal export protocols as of July 30, 2024, include the following: Argentina; Australia; Brazil; Chile; Ecuador; Nicaragua; Peru; Uzbekistan; El Salvador; and Guatemala.