FDA permanently bans Dengvaxia
MANILA, Philippines — Citing the continued failure of pharmaceutical firm Sanofi Pasteur to submit post-approval commitment documents, the Food and Drug Administration decided to permanently revoke the certificates of product registration for dengue vaccine Dengvaxia.
According to FDA Director General Nela Charade Puno, the pharmaceutical company has shown complete disregard of government rules and regulations.
"Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products," Puno said in a statement released Tuesday.
The CPR for the dengue vaccine was initially suspended for one year since Dec. 29, 2017, after Sanofi's failure to comply with post-marketing requirements.
Prior to the lapse of the one-year suspension on Dec. 17, 2018, Sanofi failed to submit and comply with post marketing authorization requirements. The company has since then suspended the sale, distribution and marketing of the dengue vaccine.
On Dec. 21, 2018, Sanofi was ordered to surrender the original CPRs of dengue tetravalent (Dengvaxia MD) and dengue tetravalent vaccine (Dengvaxia) upon receipt of order, the FDA said.
"The FDA also reminded Sanofi that pursuant to the revocation of the CPRs, it is unlawful to import, sell, or distribute the said products," the agency said.
The FDA's Center for Drug Regulation and Research has been directed to defer any submission and application of Sanofi in relation to Dengvaxia and Dengvaxia MD.
Dengvaxia vaccination program stopped in 2017
Health Secretary Francisco Duque III suspended the dengue vaccination program in December 2017 after Sanofi admitted that it could cause severe dengue if given to those who have not had the disease.
Speaking before a Senate hearing more than a year ago, Duque said Sanofi was dishonest about the risks of Dengvaxia.
"We should not allow this. We’re talking about the lives of people here. We’re talking about the lives of our children," Duque said.
Pharmaceuticals firm Sanofi Pasteur insists that it will not grant refund for the purchased dengvaxia vaccines by the Department of Health.
The firm also declines to give compensation to victims of the vaccine's botched implementation. Here's the text of the statement:
As we did in our previous reply to the DOH on 5 February, 2018, we respectfully declined both requests [to refund the government for the used doses of Dengvaxia and finally support an indemnification fund]. We stand firmly behind our product. Refunding the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case. And at this time, there is no known circumstance requiring indemnification.
We also again made very clear our willingness to sit down with the Department of Health to find other ways we can assist their efforts to combat dengue in the Philippines and restoring public trust in vaccines.
— Photo by AP
The Food and Drug Administration has permanently revoked the Certificate of Product Registration for the controversial Dengvaxia anti-dengue vaccine, The STAR's Sheila Crisostomo reports.
.@FDAPhilippines permanently revokes Certificate of Product Registration on Dengvaxia vaccines. | @shecrisostomo @PhilippineStar pic.twitter.com/xalkXJ0r8y
— Philstar.com (@PhilstarNews) February 19, 2019
The CPR for Dengvaxia had been suspended for one year since Dec. 29, 2017 after the FDA said pharmaceutical firm Sanofi Pasteur had failed to comply with post-marketing requirements.
The government's dengue vaccination program was suspended by Health Secretary Francisco Duque III after Sanofi admitted in November 2017 that it could cause severe dengue if given to those who have not had dengue.
Duque cited pending regulatory and legal issues and the lack of testing kits to detect previous dengue infection as among the reasons that would stop the return of Dengvaxia.
“Even if the suspension is lifted, who will let themselves be vaccinated with Dengvaxia?” he added.
Health Secretary Francisco Duque III calls allegations by Public Attorney's Office chief Persida Acosta the Health department tried to pay off families affected by the controversial Dengvaxia virus to drop charges "malicious, baseless and a complete lie."
He says the DOH has tried to reach out to agencies, including PAO, to work together and resolve issues surrounding the anti-dengue vaccine that the PAO is blaming for at least 32 deaths.
"[U]nfortunately, my fellow public servants at PAO led by Attorney Persida Acosta refuse to cooperate and continue to attack and throw baseless claims and accusations at the Department of Health and myself," Duque says in a statement released on DOH's social media accounts.
“I strongly call on those with negative intentions to stop propagating baseless allegations. “
— Department of Health (@officialdohgov) January 31, 2019
???? Sec Francisco Duque III responded to allegations from the Public Attorney’s Office. pic.twitter.com/0QsqglEvjG
Duque says in the same release that "baseless statements like these cause serious damage to our reputation as the primary government entity mandated to protect the health of all Filipinos."
He says Acosta's statements have contributed "to a decline in vaccine confidence in cases of Measles and other vaccine preventable diseases."
President Rodrigo Duterte himself has made a public appeal for families to get their children vaccinated despite the issues surrounding Dengvaxia, a specific vaccine that is no longer on the market in the Philippines.
Dr. Raymond Lo, pathologist and former director of the Philippine Children's Medical Center, is slapped with criminal charges before the Department of Justice over alleged deaths attributed to dengvaxia.
Hhe is included as additional respondent in pending complaints for reckless imprudence resulting in homicide, The STAR's Edu Punay reports.
Public Attorney's Office chief Persida Acosta claims President Rodrigo Duterte advised her last February to file murder complaints over alleged Dengvaxia-related deaths, news agency ABS-CBS says in a tweet.
Former President Benigno Aquino III attends the preliminary investigation hearing on the Department of Justice's probe into the inoculation of the Dengvaxia vaccine.
Also attending the hearing is former Health Secretary Janette Garin.
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