Novartis' Bexsero sparks debate about transatlantic vaccine approvals

Princeton University offered students booster shots of Novartis' ($NVS) meningitis B vaccine Bexsero this week, but while the outbreak has died down, the debate it stirred up continues. This week researchers at the Manhattan Institute weighed in with their opinion: If a vaccine is good enough for Europe, it is good enough for the U.S.

The policy research institute staffers, Paul Howard and Yevgeniy Feyman, argued their case in Health Affairs. In the post Howard and Feyman make the case for reciprocal approval of vaccines by U.S. and European regulators. Adoption of this model would have meant Bexsero would have already been on the market in the U.S. when the outbreaks began, freeing FDA and the Centers for Disease Control and Prevention (CDC) of the need to gain clearance for its use at Princeton and the University of California, Santa Barbara.

While both universities ultimately received the vaccine, there was a delay between the outbreaks being identified and immunization beginning. Reciprocal approval of Bexsero--which is already available in Australia, Canada and Europe--would have prevented these delays. It would also cut the time and money manufacturers and regulators spend taking vaccines through similar approval pathways. Postmarketing surveillance--which is already in place--could then keep tabs on the effects.

The FDA, the European Medicines Agency and other regulators have harmonized other aspects of their operations, but each agency has retained a tight grip on their drug and vaccine approvals. The Health Affairs post suggests that regulators fear losing the clout and review fees that go with approval powers. Others worry that the reciprocal model would drive authorities to loosen regulations to attract more applications. Howard and Feyman think making reciprocity limited and optional would alleviate some of the concerns, while existing legal measures would ensure that standards were maintained.

- here's the Health Affairs post
- check out the Princeton news