Aviron's control issues

After repeated setbacks in the last mile of the regulatory process for its FluMist intranasal live cold-adapted trivalent influenza vaccine - setting up production - Aviron is taking over primary responsibility for manufacturing the product.

Downstream issues have been at the forefront of delays in FluMist development. In 1998, AVIR received a refusal-to-file letter from the FDA that cited validation issues with respect to operations and performance, instruments at the product's manufacturing facilities and the facilities themselves, as well as bioequivalence and product stability (see BioCentury Extra, Sept. 2, 1998)...