First FDA approved vaccine for dengue prevention, but with restriction

The US Food and Drug Administration announced yesterday the approval of Dengvaxia, the first approved vaccine for the prevention of dengue fever caused by all dengue virus serotypes (1, 2, 3 and 4) in people aged 9 to 16 years dengue and who live in endemic areas ..

Approval was granted to Sanofi Pasteur, the vaccines unit of the French pharmaceutical group Sanofi (Euronext: SAN).

The vaccine has been approved for use in several countries, including the Philippines, Latin America and Asia, and the European Commission has authorized the release of Dengvaxia last December. It is also recommended by the World Health Organization, but a year ago the WHO said it should only be used in people with proven previous exposure to dengue fever.

Dengvaxia has aroused significant controversy because of evidence that it can increase the risk of serious infection in some people. In the Philippines, where the vaccine was suspended in December 2017, the local Food and Drug Administration said in February of this year that the French manufacturer had not submitted the post-approval documents required by the US Food and Drug Administration. control of the country and had definitely banned the treatment.

The use of Dengvaxia is not approved in people who are not yet infected with a dengue virus serotype or for whom this information is unknown. In fact, in people who have not been infected with the dengue virus, dengvaxia seems to act as a first infection of dengue fever – without actually infecting the person with the wild-type dengue virus. so that a subsequent infection can lead to severe dengue disease. Therefore, health professionals should evaluate people for pre-dengue infection so as to avoid vaccinating people who have never been infected with the dengue virus.

The various restrictions make the US vaccine market even smaller than the already modest market thought. Dengue fever is endemic in the American territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.

"Dengue fever is the most prevalent mosquito-borne viral disease in the world and the global incidence has increased in recent decades," said Anna Abram, FDA's Deputy Commissioner for Policy, Legislation and international affairs. "The FDA is committed to working proactively with its partners in the US Centers for Disease Control and Prevention, as well as with its international partners, including the World Health Organization, to address the threats that lie ahead. public health, including facilitating the development and availability of medical products. treat emerging infectious diseases. Although dengue fever can not be cured, today's approval is an important step in reducing the impact of this virus in endemic areas of the United States. "