DOH says Dengvaxia ban likely to stay

MANILA, Philippines — While the one-year ban imposed on Dengvaxia is about to end, the Department of Health (DOH) said yesterday that the agency does not see the anti-dengue vaccine being used anytime soon.

In an interview, DOH Undersecretary Eric Domingo noted that the one-year suspension of the marketing license of Dengvaxia will likely be extended after Dec. 29.

“The one-year suspension of the Certificate Product Registration (CPR) of Dengvaxia is not yet lifted and I don’t see it being lifted anytime soon,” Domingo added.

On Dec. 29, 2017, the Food and Drug Administration (FDA) suspended the CPR of Dengvaxia for one year after its manufacturer Sanofi Pasteur had failed to comply with post-marketing requirements.

Domingo said the DOH does not see the product being registered and sold again in the country right after the one-year suspension of its CPR. 

The 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.

DOJ ends probe

Meanwhile, the Department of Justice (DOJ) has concluded its preliminary investigation on criminal charges against former health secretary Paulyn Jean Ubial over the deaths of school children inoculated with the controversial Dengvaxia vaccine.

Investigating Assistant State Prosecutor Claire Eufracia Pagayanan has submitted the case for resolution after the last hearing on Monday where Ubial submitted her rejoinder and sought dismissal of the charges of reckless imprudence resulting in homicide for lack of basis.

The complaint against Ubial was filed by her predecessor, former health secretary Janette Garin, who herself is facing a string of criminal charges over the alleged Dengvaxia deaths filed by families of victims.

Ubial branded as “false and unfounded” the accusation of Garin that she should be held criminally liable because it was she who decided to shift the dengue immunization program from being school-based to community-based, contributing to the alleged deaths among immunized children.

She stressed that Garin “merely surmises that the implementation of the Community-Based Dengue Immunization Program ‘may have’ contributed to ‘alleged reported deaths’.”

Ubial also refuted the claim of Garin that the community-based implementation of the dengue immunization program was contrary to World Health Organization recommendations that immunization programs should be school-based.

Ubial explained that she was “not negligent or imprudent in implementing the Community-Based Dengue Immunization Program” and that the decision to implement it was “a result of discussions by the (DOH) executive committee, consultations with medical experts and was supported by scientifically and medically backed-up research culled from several years of clinical trials.”

Garin, who is facing a string of criminal charges herself before the DOJ over deaths attributed to Dengvaxia, served as health chief from December 2014 to June 2016, followed by Ubial, who was in the post from July 2016 to October 2017. 

A total of 29 cases for reckless imprudence resulting in homicide and violations of the Anti-Torture and Consumer laws have been filed against Garin and 37 other health officials, executives of Sanofi and its distributor Zuellig Pharma.

The Public Attorney’s Office, which has been tapped to conduct a fact-finding probe and build up cases in the Dengvaxia controversy, earlier explained that Ubial has not been charged in their cases because she would be used as a prosecution witness. – With Edu Punay