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CA denies plea of Sanofi Pasteur to reinstate product registration for Dengvaxia vaccine
CA denies plea of Sanofi Pasteur to reinstate product registration for Dengvaxia vaccine
The Court of Appeals (CA) has denied the petition filed by Sanofi Pasteur, Inc. which challenged the government’s decision to revoke its certificates of product registration (CPRs) for Dengvaxia, the controversial dengue vaccine.
In a decision written by Associate Justice Eduardo S. Ramos Jr., the CA said: “All told, it is our view that the expiration of the marketing authorization on Dec. 22, 2020, has rendered this case moot and academic. It is thus futile to insist on the reinstatement of the CPRs whose validity period had long expired.”
Case records show that on Dec. 29, 2017, the Food and Drug Administration (FDA) suspended Sanofi’s CPRs for one year with a fine of P100,000 for failure to submit post approval commitment documents. On Dec. 21, 2018, FDA revoked Sanofi’s CPRs.
Sanofi asked FDA to reconsider the revocation. It claimed it was denied due process for lack of notice. It also said that it had complied with the post marketing authorization requirements.
When its motion for reconsideration was denied by FDA, it filed an appeal before the Office of the Secretary of the Department of Health (DOH) which denied the appeal on Aug. 19, 2019.
Sanofi then appealed to the Office of the President which also denied its plea.
Undaunted, it filed a petition before the CA. It told the CA that even if it failed to comply with its post-marketing authorization requirements, there is no basis for the immediate revocation of the CPRs.
Ruling against the petition, the CA – agreeing with the Office of the Solicitor General which represented the FDA and the DOH – ruled that the reinstatement of the pharmaceutical firm’s CPRs would no longer be possible as it had already expired on Dec. 22, 2020.
“To be clear, however, this Court finds that the issue at hand is not the efficacy of Dengvaxia. Rather, the crux of this controversy centers on the compliance or non-compliance of the post-marketing authorization requirements by Sanofi,” the CA stressed.
“Simply, the expiration of the marketing authorization on Dec. 22, 2020 operates as a supervening event that mooted this petition,” it ruled.
During the administration of the late former President Benigno Aquino III, the government procured P3.5 billion worth of Dengvaxia vaccines which was registered with FDA in 2015.
The vaccines were administered to children in 2016.
The controversy erupted when Sanofi issued an advisory that the clinical analysis on Dengvaxia showed that the vaccine is effective for people who have had dengue prior to immunization, but citing a risk of a "severe" case of dengue for people who have not.
As a result, criminal cases have been filed against the former and incumbent DOH officials in connection with deaths and injuries attributed to the alleged use of Dengvaxia vaccines.