Sanofi Pasteur has lost local approval for its intradermal influenza vaccine, IDflu, in 15 micrograms and 9 micrograms in Korea.
The vaccine division of the French multinational drugmaker did not request for the health authorities’ reassessment twice, which made the regulator automatically cancel the license.
Observers said the company might have given up on the renewal of approval intentionally to withdraw from the Korean market, after failing to sell the vaccine well.
The Ministry of Food and Drug Safety ordered an administrative measure on Monday to drop the license for IDflu.
To receive reevaluation for new drugs under the Pharmaceutical Affairs Act, a drugmaker should submit a reassessment application form and periodic report results with data analyzed and evaluated thoroughly, to the ministry.
Rumors have been circulating since last year that Sanofi Pasteur might abandon IDflu sales in Korea.
IDflu has the same ingredient as Sanofi Pasteur’s another flu vaccine Vaxigrip but involves a different administration method – a slight needle prick instead of a deep injection. IDflu in 9 micrograms and 15 micrograms won the local license in 2010.
Based on findings that people do not take flu vaccinations for fear of needle injection, Sanofi emphasized that IDflu use a 1.5-millimeter needle, one-tenth that of conventional syringes. However, the vaccine failed to sell well in Korea due to the weak promotion and people’s reluctance to try out a new type of needle.