Sanofi Korea said its high-dose influenza vaccine Efluelda, designed for seniors, received marketing authorization from the Ministry of Food and Drug Safety on Nov. 29.

Efluelda is the first high-dose influenza vaccine approved in Korea for the elderly, preventing influenza caused by type A and B virus strains in individuals aged 65 and older.

According to Sanofi, despite high influenza vaccination rates among the elderly in Korea, two-thirds of all influenza-related deaths occur in those aged 60 and above.

Influenza infection can significantly increase the risk of strokes by eight times and myocardial infarction by 10 times in adults over 40, leading to severe complications in various organs.

Elderly individuals are particularly vulnerable to influenza infection and its complications due to decreased immune function and underlying health conditions, and the protective effect of vaccines is lower than that in younger adults.

Sanofi has been focusing on developing vaccines that prevent influenza and its severe complications by setting criteria.

The criteria included confirmed infection prevention in labs, reduced hospitalization rates, active use of randomized study designs, using existing standard-dose influenza vaccines instead of placebos as control groups, and consistent long-term research results.

Efluelda was the only influenza vaccine that met all five criteria.

In randomized clinical trials, Efluelda consistently showed superior influenza prevention and reduced hospitalization rates compared to standard-dose vaccines.

The high-dose influenza vaccine, which contains four times more antigens than standard vaccines, prevented 24.2 percent more influenza infections compared to standard-dose vaccines while also reducing the hospitalization rates for influenza and pneumonia by 64.4 percent.

Also, a meta-analysis of studies, including randomized clinical trials conducted over twelve influenza seasons on over 45 million seniors aged 65 and above, consistently demonstrated the high-dose vaccine's superior effectiveness in preventing influenza and reducing hospitalizations due to complications.

Based on such medical evidence, several countries and health organizations have published guidelines acknowledging the preventive effects of Efluelda against influenza and its complications.

"We are pleased to introduce this high-dose influenza vaccine in Korea, which can strongly protect the elderly from influenza and related complications," Sanofi Korea General Manager and Representative Director of Vaccines Pascal Robin said.

Sanofi hopes that the elderly in Korea will widely receive this high-dose vaccine, which has been proven to offer a higher level of prevention, through the national immunization program, he added.