FDA Panel Backs Live Oral Polio Vaccine

5 December 1994

The US Food and Drug Administration's Vaccines & Related Biological Products Advisory Committee has decided that the trials put forward by Connaught Laboratories in support of its trivalent oral live polio vaccine (OPOL) are adequate to support the filing of a Product License Application.

Seroconversion rates achieved with Connaught's OPOL vaccine were above 90% for each polio virus serotype, which compares closely to a similar product, Lederle Laboratories' Orimune, which is already on the market in the USA. Connaught says it is now in the process of ironing out some of the technical details in its PLA.

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