Sanofi appeals revocation of Dengvaxia’s registration

MANILA, Philippines – Pharmaceutical firm Sanofi Pasteur has filed an appeal with the Office of the President on the permanent revocation of the certificate of product registration (CPR) of Dengvaxia vaccine, Health Secretary Francisco Duque III revealed yesterday.

Speaking during the Kapihan sa Manila Bay media forum at the Cafe Adriatico in Manila, Duque said Sanofi has not re-filed an application for CPR to bring back the anti-dengue vaccine to the Philippines, although the pharmaceutical company submitted an appeal to Malacañang. 

In August, the Food and Drug Administration (FDA) decided to uphold the revocation of the CPR of Dengvaxia due to the failure of Sanofi to comply with post-marketing requirements. 

Duque said the permanent revocation of the registration is “without prejudice to applying for a new CPR and also ensuring they are compliant with all the documentary requirements.”

He reported that from Jan. 1 to Sept. 21, around 320,000 dengue cases were recorded by the Department of Health (DOH).

Duque said the huge number of cases is not only being experienced in the Philippines, but in other countries in Asia as well like Singapore, which is known for cleanliness.

Citing reports of the World Health Organization, Duque said the People’s Democratic Republic of Lao, Cambodia, Vietnam, Thailand and Singapore, on the average, are seeing 300 to 400 percent increase in cases.

“This is horrible. In Malaysia and the Philippines there are about 100 to 200 percent increase. Not as horrible as our other neighboring countries,” he said.

Garin: Dengvaxia prevents dengue

The controversial Dengvaxia vaccine prevents dengue, although it reportedly did not work on the daughter of President Duterte, House senior deputy minority leader and Iloilo Rep. Janette Garin said yesterday.

Duterte’s daughter Kitty contracted dengue despite having received Dengvaxia, which prompted the President to rush back from his official visit to Russia last week.

Garin, former health secretary who is facing multiple cases of reckless imprudence resulting in homicide and graft over deaths attributed to the vaccine, stood firm on her position that Dengvaxia is effective.

She reiterated that the vaccine would protect children from dengue.

“Those who can afford the (Dengvaxia) vaccine should be given the option to have it. That way, we protect them from severe dengue with major and sometimes fatal complications,” Garin replied when asked to comment on Kitty’s case.

In August this year, Duterte said he is open to the resumption of the government’s Dengvaxia vaccination program to avert a national dengue epidemic that had claimed over 600 lives nationwide since January.

Duterte said Kitty and his granddaughter Sabina, daughter of Davao Rep. Paolo Duterte, both got Dengvaxia shots.

President Duterte, meanwhile, has taken time off this week after a five-day official visit to Russia to watch over his dengue-stricken daughter.

Kitty, however, is reportedly recovering fast since her hospitalization last Sunday. Edu Punay, Edith Regalado