Metro Manila (CNN Philippines, August 22) – The Department of Health (DOH) has denied the plea of vaccine manufacturer Sanofi Pasteur to reverse the decision revoking the certificate of product registration (CPR) of its vaccine as the country faces a dengue epidemic.
She said she wanted Duque probed for deciding to keep the dengue vaccine off the shelves.
The Health department, in a decision dated August 19, upheld the Food and Drug Administration’s decision to the cancel Dengvaxia’s CPR due to Sanofi Pasteur’s failure to submit post-approval requirements.
Health Secretary Francisco Duque III, in a briefing on Thursday, said he made the decision based on Sanofi’s “complete disregard of FDA regulations, which were put in place to ensure public safety and “its efficacy is not in issue”.
Duque noted that it is “critical” for Sanofi Pasteur to comply with requirements since Dengvaxia, which was said to have “aggravated” the rate of immunization in the country, is an “innovative” vaccine.
He said Sanofi Pasteur failed to submit the third and fourth versions of risk management plans, which include its report on what has been done since the Dengvaxia scare in 2017 where more than 830,000 individuals from Central Luzon, Calabarzon and Metro Manila had been given Dengvaxia at least once through the country’s mass immunization program under then-Health Secretary Janette Garin’s watch.
The FDA first suspended Dengvaxia’s registration in 2017 after Sanofi Pasteur issued an advisory, saying that Dengvaxia poses a serious health risk to those with “seronegative” status, or individual who had no prior history of dengue infection. In December 2018, the FDA officially cancelled the product registration of Dengvaxia.
This prohibited Sanofi Pasteur from selling, distributing and manufacturing the vaccine.
Garin, now Iloilo 1st District representative, believes politics was behind the revocation of Dengvaxia’s CPR.
A number of deaths allegedly from Dengvaxia have been reported, prompting a string of lawsuits from aggrieved parents and a dramatic drop in the national vaccination coverage. But there has so far been no official findings linking the vaccine to the deaths.
The Health chief also said that upon the recommendation of the Dengue Vaccine National Expert panel, Sanofi Pasteur may re-apply for a product registration renewal and submit an updated data on the monitoring of the effects of pharmaceutical products licensed for use on patients and post-marketing surveillance.
He said that makers of other innovative products are welcome to apply for a CPR, which may take approximately three to six months, provided that they comply to FDA rules and regulations.
The DOH said it is responding to the dengue epidemic nationwide.
The Health agency recently declared a national dengue epidemic due to high cases of the mosquito-borne virus.
From January 1 to August 3, a total of 188,562 suspected dengue cases were recorded by the department’s epidemiology bureau, with 807 deaths. This figure is higher than the 93,149 reported in the same period last year.
In just a week alone, from July 28 to August 3, the bureau reported 14,321 cases, with 39 deaths, higher than the cumulative cases in the previous week.
Mostly affected were young patients 5-to-9-years of age.
Sanofi Pasteur denies violating FDA regulations
Meanwhile, Sanofi Pasteur, in a statement, expressed gratitude to the DOH for acknowleging that the “safety of Dengvaxia is not on trial.”
The firm denied that it committed violations cited by the FDA to permanently revoke its product registration.
Sanofi Pasteur also said it will study all legal remedies available so Dengvaxia could be re-introduced to the Philippine market.
“Nakakalungkot po na masyadong nagiging politiko ang ating Secretary of Health at hindi niya po sinusunod ang nararapat para sa kalusugan ng lahat,” Garin said.
[Translation: It’s sad that our Secretary of Health is becoming too much of a politician and he is not doing the right thing for everyone’s health.]
Duque said Sanofi-Pasteur may also appeal to the President
The Office of the President could reverse the decision to revoke Dengvaxia’s permit, Duque said.
“In the principle of exhaustion of administrative remedies in this case extends all the way up to the Office of the President regarding the upholding of the permanent revocation of the CPR of Dengvaxia,” he said.
CNN Philippines Correspondent Xianne Arcangel contributed to this report.
