PMA supports restoration of Dengvaxia registration

MANILA, Philippines — The Philippine Medical Association (PMA) yesterday expressed support for the restoration of the certificate of product registration (CPR) of Dengvaxia vaccine to combat dengue in the country.

Without specifically mentioning Dengvaxia, the PMA said it “supports World Health Organization (WHO)’s recommendations on the use of the dengue vaccine as a supplement to other preventive measures, particularly on vector control and early detection and appropriate treatment.”

“PMA is in favor of considering re-registration of dengue vaccine, provided that all the national regulatory requirements are met,” the group noted in a position statement. 

But it underscored “specific recommendations” of WHO must be followed in making the vaccine available in the market again, such as that the vaccine should be given only among individuals who are “nine to 45 years old with evidence of previous dengue infection.”

It added that prior to vaccination, “serological screening using Dengvaxia IgG ELISA or rapid diagnostic tests should be carried out.”

“Clinical trials and studies have shown that dengue vaccine will help individuals who have previous dengue infections from getting severe dengue,” the group said.

The PMA maintained that the vaccine “may be given to individuals who are interested, willing and aware of the benefits and possible risks of the vaccine.”

“We respect and support the opinion of our specialty societies on the issue and we confirm that there is consistency on our various position statements,” it added.

A separate statement signed by PMA secretary general Ricardo Batac showed the group has reiterated that as doctors, they are committed to mitigating the suffering of their patients.  

Batac said “as indispensable partners of the healthcare system in building a healthy nation, doctors deserve respect and dignity.”

“We are not commodities who are easily disposed of at the whims and caprice of others,” he added.

Last February, the Food and Drug Administration (FDA) permanently cancelled the CPR of Dengvaxia after its manufacturer Sanofi Pasteur failed to comply with some post-marketing requirements.  

In July, the company filed an appeal with the Department of Health but last Aug. 22, the DOH decided to reject it and uphold the ban imposed by the FDA on the vaccine.

This once again revived debates, primarily among Filipino doctors, on whether or not the vaccine should be allowed in the market again.

Some doctors believe that Dengvaxia can be used again, not for mass vaccination but for voluntary immunization in private clinics.

On the other hand, there are doctors who believe the vaccine should no longer be given CPR because of the serious danger that it poses to vaccinees, especially children.

Based on latest data from the DOH, there were 208,917 reported dengue cases from Jan. 1 to Aug. 10, including 882 deaths.  

This is double the 102,298 dengue cases documented during the same period in 2018.  There were 540 deaths then.

Ten regions have exceeded the epidemic threshold. These are Calabarzon, Mimaropa, Bicol, Western Visayas, Eastern Visayas, Zamboanga Peninsula,  Northern Mindanao, SOCCSKARGEN, Bangsamoro Autonomous Region in Muslim Mindanao and National Capital Region. 

Public debate

A public health vaccination specialist from the Volunteers Against Crime and Corruption (VACC) has challenged some infectious disease and vaccine experts from the University of the Philippines-Manila (UP-M) to a public debate on Dengvaxia.

According to Francisco Cruz, a doctor, he wants to have a face-off with some doctors at the UPM who are defending the use of Dengvaxia in the country.

“(Let’s) resolve that Dengvaxia is a stupid public health vaccine... I respectfully propose that UP-M College of Public Health host the public debate,” said Cruz, who had appeared as expert witness of VACC on public health during Senate hearings on Dengvaxia in the past. 

He addressed his challenge to Edsel Maurice Salvana, director of the Institute of Molecular Biology and Biotechnology at UP-M’s National Institutes of Health; Lulu Bravo, convenor of Doctors for Truth, and Vicente Belizario, former undersecretary of the DOH. 

Cruz added that he would be joined by two pro-Dengvaxia victim and health advocates in discussing why the Philippines should already abandon the use of Dengvaxia in any setting.