DOH medical expert panel: Dengvaxia rollout 'premature'

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Metro Manila (CNN Philippines, December 12) — The panel of medical experts consulted by the Health Department on drug procurement said the rollout of the controversial anti-dengue vaccine was premature.

At the Senate probe on Dengvaxia, the Blue Ribbon Committee Chair Sen. Richard Gordon asked the Formulary Executive Committee (FEC) if the release of the drug was premature.

FEC members Dr. Cecilia Lazarte and John Wong, Atty. Froilan Bagabaldo and secretariat Dr. Melissa Guerrero, who were present at the hearing, said yes.

The FEC, under Executive Order No. 49, is mandated to determine and assess which drugs should be part of the National Formulary, the list of drugs allowed to be bought by the government.

During the Senate inquiry, Gordon showed the minutes of the meeting on January 7 and 25, 2016 — saying that the FEC deferred the recommendation of the drug until other requirements are provided.

Atty. Froilan Bagabaldo, a member of the FEC, claimed eight conditions were imposed before the Health Department could push through with the program. These included the procurement of vaccines in tranches, as well as a risk management plan from the Food and Drug Administration (FDA).

"I'd like to make it clear, that the role of the FEC is recommendatory. Okay, in recommending the exemption, we placed certain conditionalities," Bagabaldo said.

But on January 21, Health Undersecretary Kenneth Hartigan-Go reportedly said during his meeting with the council that the recommendation to include Dengvaxia in the national formulary is "not yet imperative."

"A political decision to allot the budget from the national agencies' savings was already made by a higher committee," Usec. Hartigan-Go was quoted saying.

Former Health Secretary Janette Loreto-Garin then issued a certification of provisional exemption for Dengvaxia on February 3.

Under Administrative Order 163 of 2002 or the Implementing Guidelines Philippine National Formulary System, medicines to be exempted from the formulary shall meet the following requirements:

  • The medicine will be used for a national health program or for a current or potential urgent health situation;
  • The medicine has proven safety and efficacy; and
  • The approval for the request shall only be effective for the duration of the national health program or until the urgent health situation has passed or has been adequately addressed.

The government kicked off its ₱3.5-billion, school-based dengue immunization program in April 2016.

The controversial vaccine was administered to more than 830,000 students in Metro Manila, Region III, and Region IV.

On November 29, 2017, the pharmaceutical company behind the vaccine, Sanofi Pasteur, released a statement that those who did not have previous dengue infection but received the vaccine are at risk of contracting "severe disease."

Health officials said around 10 percent of those who were vaccinated did not have a prior dengue infection.

Another 32,000 private patients were also vaccinated.