Sanofi Pasteur representative Thomas Triomphe. NOY MORCOSO / INQUIRER.net
French pharmaceutical Sanofi Pasteur “has no business to distribute” Dengvaxia vaccines in the Philippines if it had not been registered with the European Food and Drug Administration (FDA) counterpart, a lawmaker asserted on Monday.
During the fourth hearing of the House of Representatives on the P3 billion anti-dengue immunization program of the Department of Health (DOH), Sanofi Asia-Pacific head Thomas Triomphe, upon the questioning of Iloilo Rep. Ferjenel Biron, confirmed that their vaccine had not been registered by the European Medicines Agency prior the approval of the vaccines in the Philippines.
Biron lamented this, saying that if this is the case, then “Sanofi had no business to distribute it in the Philippines.”
Philippine FDA Acting Deputy Director General for Field Regulatory Operations Maria Lourdes Santiago explained that “there are at least three batches (of vaccines) that they have to produce prior to product registration.”
Santiago, however clarified, that Sanofi “satisfied requirements for vaccine prior to registration, so FDA issued clearance.”
“We approved their registration because we have no basis in objecting,” she added.
Triomphe meanwhile, reiterated that “safety and efficacy were demonstrated before the registration (of their vaccines).”
In April 2016, the DOH, under former Health Secretary Janette Garin’s watch, bought Dengvaxia intended for public schoolchildren in areas with high incidences of dengue.
But the vaccination drive was halted by current Health Secretary Francisco Duque III when Sanofi revealed in November 2017 that Dengvaxia could worsen symptoms of the disease for people who had not previously been infected by the virus. /kga