Sanofi to seek dialogue with FDA after Dengvaxia pull-out order
Sanofi Pasteur has announced that it will be seeking a dialogue with the Food and Drug Administration (FDA) after the latter decided to suspend the distribution of the anti-dengue vaccine Dengvaxia in Philippine markets.
“We were informed of the position of the Philippine Food and Drug Administration which was published on December 4, 2017 and will work with them to review the implementation of their direction. We will continue to seek constructive and transparent dialogue with them,” Sanofi said in a statement Tuesday.
Sanofi assured the public that Dengvaxia does not contain viruses that can infect people with dengue or severe dengue.
“If you have had no previous dengue infection before vaccination, the vaccine does not give you dengue,” Sanofi stressed.
The pharmaceutical firm insisted that an estimate of only one in 800 of all dengue infections, including symptomless infections, could lead to a severe infection.
“The increased risk identified from the new analysis translated to 2 additional cases of “severe dengue” out of 1000 previously dengue-uninfected people vaccinated over 5 years of follow-up. In this group, all fully recovered with proper medical treatment,” it said.
The FDA, in its advisory dated December 4, ordered the suspension of the sale, distribution, and marketing of Dengvaxia, as well as the removal of the product in the market.
FDA director general Nela Charade Puno said the order was issued to protect the general public after the vaccine manufacturer, Sanofi Pasteur, disclosed that the product may have potential risk to patients who have not had dengue prior to immunization. /je
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