The Food and Drug Administration said it would meet today, Dec.21, to decide whether to give a Certificate of Product Registration (CDR) to Dengvaxia, Sanofi Pasteur’s controversial anti-dengue vaccine.
“The FDA is set to meet about the Dengvaxia CPR tomorrow afternoon. They will probably decide then,” Health Undersecretary Rolando Domingo said.
Domingo said that the Health Department will study whether it would administer the anti-dengue vaccine after the European Commission has given the authority to market Dengvaxia on Thursday, Dec. 20.
In a separate statement, Sanofi said that: “The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve use of the dengue vaccine in European endemic areas.”
Sanofi PasteurT said that Dengvaxia will be made available in Europe to prevent the dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas.
“In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again,” the company said.
“As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections,” Dr. Su-Peing Ng, Global Medical head at Sanofi Pasteur, said.
Sanofi Pasteur is the vaccine unit of Sanofi.
Denvaxia, however, became controversial in the country, after at least 106 deaths were linked to vaccine.
Authorities have yet to determine if indeed Dengvaxia caused the children’s deaths, despite cases already filed against the pharmaceutical company.
The controversy started when Sanofi officials announced in November 2017 that the vaccine posed a serious health risk to those who were not previously infected by the virus.
By then, the vaccine has been administered to more than 800,000 children as well as some adults and policemen.
Without admitting any wrongdoing, Sanofi returned P1.16 billion to the Department of Health for the unused doses of Dengvaxia.
Health Secretary Francisco Duque III said last November that because of the controversy, public trust on vaccines administered by the government dropped to 33 percent from 92 percent.