MANILA, Philippines – Pharmaceutical giant Sanofi Pasteur has accepted the Department of Health (DOH) decision to uphold the ban on Dengvaxia’s certificate of product registration (CPR), although it insisted that the assailed dengue vaccine is ‘valuable’.
Despite the decision, Sanofi on Thursday (Aug. 22) thanked the DOH for clarifying that the issue was not about Dengvaxia’s safety.
“Sanofi Pasteur acknowledges the Department of Health (DOH) as the country’s principal health agency committed to ensuring access to health for all Filipinos,” the company said.
“While we respectfully disagree with the cited violations that led to the decision denying our appeal on procedure, we are grateful to the DOH for recognizing that the ‘safety of Dengvaxia is not on trial’, and for emphasizing ‘the dire need to have [a dengue vaccine] introduced or – in the case of Dengvaxia – reintroduced in the market’,” it added.
Earlier, Health Secretary Francisco Duque said that the French company’s CPR for Dengvaxia was revoked after its “continued failure to submit post-approval requirements.”
This was a reiteration of an earlier Food and Drug Administration (FDA) ruling.
“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” Duque said in a separate statement.
READ: DOH denies Sanofi appeal to lift ban on Dengvaxia
The DOH also noted that Sanofi may reapply for a CPR for Dengvaxia, saying that the rejection would not affect later applications.
“Likewise, while the Department has upheld the decision of the FDA that permanently revokes the certificate of product registration (CPR), we are grateful to the Department for providing clarity that ‘this [decision] is without prejudice to the re-application… for CPRs for Dengvaxia’,” Sanofi said.
“With this, we will thoroughly study all possible remedies available to us under Philippine laws and regulations while keeping in mind the best interest of the Filipinos,” it added.
The possible reuse of Dengvaxia, which was withdrawn by Sanofi in 2017 after studies showed negative effects on vaccinated patients who have yet to contract the dengue virus, was raised by Malacañang and President Rodrigo Duterte recently.
According to Public Attorney’s Office (PAO) Chief Persida Acosta, who has investigated the Dengvaxia fiasco, there are over 100 deaths due to severe dengue, caused by Dengvaxia.
Still, Duterte’s suggestion was intended to curb the rising incidence of dengue in the Philippines, which has prompted DOH to declare a nationwide dengue epidemic.
READ: As dengue rises, Palace open to Dengvaxia use
READ: Duterte: ‘I’m open in the use of Dengvaxia again’
READ: BREAKING: DOH declares national dengue epidemic
Sanofi had insisted that Dengvaxia is valuable to the country, after the World Health Organization (WHO) listed it as an essential medicine.
“The dengue vaccine has been included in the WHO 2019 List of Essential Medicines. The supporting data of our registration files have been validated by Philippine experts along with the WHO Strategic Advisory Group of Experts on Immunization (WHO-SAGE), the European Medical Agency (EMA), the USFDA, and 20 other countries worldwide,” Sanofi said.
“We are confident in the public health value of this vaccine,” it added./TSB