Karen Lema, Reuters, Dec 11, 2017
MANILA (Reuters) - Philippine public officials showed "reckless disregard of processes" in carrying out a program to immunize hundreds of thousands of children, a senator leading an investigation into the government's use of a new dengue vaccine said on Monday.
On Dec. 1, the Philippines halted use of Dengvaxia after its maker, French drug firm Sanofi said the vaccine itself might, in some cases, increase the risk of severe dengue in recipients not previously infected by the virus.
Dengue is not as serious as malaria, but it kills about 20,000 people each year and infects hundreds of millions as it spreads rapidly in many parts of the world. The Philippines reports an average of 200,000 cases every year, the DOH said.
Senator Richard Gordon, chairman of the investigation panel, said the program's approval and procurement were done with "undue haste", given how quickly the department of health (DOH)got funding for the 3.5-billion-peso ($69.55-million) campaign.
Gordon said "rushed" approval was given to a "vaccine that has not been proven to be totally effective".
But Sanofi insisted otherwise. "We at Sanofi assure each and everyone of you that Dengvaxia is, and continues to be, a safe and efficacious vaccine," said Thomas Triomphe, Asia-Pacific head of Sanofi Pasteur.
"To permanently remove the vaccine from the Philippine market...would be a regression in the country's approach to solving a major public health concern and a disservice to the Filipino people."
The roll out of the mass vaccination program was "premature," some doctors and pharmacologists on a DOH advisory body told the senate inquiry.
They were the same group of experts who in January 2016 urged caution over the vaccine, saying its safety and cost-effectiveness had not been established.
After two meetings in January, the Formulary Executive Council (FEC) of advisers approved the government's purchase of the vaccine on Feb 1, 2016 but recommended stringent conditions, minutes of all three meetings show.
However, these recommendations were not heeded by then health secretary Janette Garin before the program was rolled out to 830,000 children, documents reviewed by Reuters, as well as interviews with local exports, show.
The same recommendations and minutes of the meetings were discussed during the five-hour senate hearing.
Garin said the procurement of the vaccine was above board. "I categorically deny any wrongdoing," she told the inquiry. "I am not involved in any corruption and I am willing to be investigated."Many parents are anxious and worried over the safety of the vaccine. Iris Alpay, one of the parents who attended the hearing, admonished health officials for using their children as "experimental rats".
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