January 21, 2018, 12:40 am
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Aquino: No rush, no protests on Dengvaxia

FORMER President Benigno Simeon Aquino III yesterday said there was no undue haste in the approval of the purchase of P3.5-billion worth of dengue vaccines during his administration. 

Aquino, during the resumption of the Senate blue ribbon committee hearings on the purchase of the Dengvaxia vaccines, also confirmed that he met with officials of Sanofi Pasteur, the vaccine’s manufacturer, twice but no one told him about the firm’s flecked record abroad or the issues against Dengvaxia.

The former president said he met with officials of the French pharmaceutical company on Dec. 1, 2015 while he was in Paris for the UN Conference on Climate Change. At the sidelines of the conference, he met businessmen from Vivapolis, Airbus, Jacobi, CRH, Usine IO and Sanofi.

It was then, he said, that Sanofi officials told him that the vaccines were ready.

On Dec. 10, 2015, then Health Secretary Janette Garin submitted a proposal to the Department of Budget and Management (DBM) for health facilities enhancement program (HFEP) funding and procurement of dengue vaccines.

On Dec. 23, a memorandum was issued by then Budget Secretary Florencio Abad to fund projects from the Miscellaneous Personnel Benefits Fund (MPBF) and Pension Gratuity Fund (PGF) savings. Among the projects identified was the dengue vaccination program.

On Dec. 29, a Special Allotment Release Order (SARO) was issued by the DBM to the DOH, obligating P3.5 billion for the vaccination program.

Aquino explained that savings had to be used to purchase the vaccines, because if not, “you are practically saying that the first implementation of this vaccine will be in 2017 because it will be for the next budget cycle, which will be under the new administration.”

He also said there was no guarantee the vaccines will be administered considering a “learning curve” at the start of every presidency.

“The choice is simple. We can implement it at this point in time for the protection – or wait at least a year as minimum and expose our people to a risk that could have been prevented because of this vaccine,” he added.

Aquino, in his opening statement, said before he approved the purchase of Dengvaxia, while he was still deciding, and even after he decided, no one protested.

He said Dengvaxia was given to 830,000 children in Metro Manila, Calabarzon and Central Luzon because data from the Department of Health showed that they were the regions most affected by dengue in 2015.

He said if he let his “bosses” suffer despite the existence of the vaccines, his critics would then accuse him of negligence.

Aquino said his administration began to focus on dengue after receiving a memorandum from former health secretary Enrique Ona dated Aug. 23, 2010, which highlighted the prevalence of dengue in five regions affecting around 2.8 million people.

He said two of the regions had more than 100 percent increase in dengue cases. Another, he said, had a 1,409.5 percent rise in cases.

Aquino said the vaccine went through “local and international processes.”

He said he was told that the US Food and Drug Administration regulates international clinical trials and that Dengvaxia underwent the process.

Besides, it was not only the Philippines that approved the administration of vaccines.  He said Mexico and Brazil did as well.

The vaccination program began on April 2016, just a month before the May presidential elections.

He said when he approved the purchase of the vaccines, he was not aware of the controversial issues faced by Sanofi Pasteur.

Senate blue ribbon committee chair Richard Gordon, during the hearing, enumerated a list of charges against Sanofi in other parts of the world.

He cited an instance back in 2012 when Sanofi was fined $109 million in the United States for violating the False Claims Act. Sanofi was also accused of bribery in several instances in the past.

Gordon also said there was a rush to buy Dengvaxia and that the vaccines were nearing expiration when they are purchased. He said the earlier expiry date was September 2017.

Sanofi officials said the vaccines had more than 18 months of life, which means they comply with DOH requirements.

Former health secretary Paulyn Ubial told the Senate hearing that she was under a lot of pressure from local officials after she halted dengue vaccination when she become health chief.

Ubial said among those who pressured her into introducing Dengvaxia was Garin’s husband, Iloilo Rep. Oscar Garin Jr. She said Cebu Rep. Gwendolyn Garcia badgered her into including Region VII in the dengue vaccination program. 

She linked her non-confirmation in the Commission on Appointments to the Dengvaxia fiasco.
 
NO PANIC

Thomas Triomphe, the head of Sanofi Pasteur for the Asia-Pacific region, said Dengvaxia continues to be safe and effective in providing persistent protection against the dengue infection.

Triomphe told senators that there is no “world-wide” scare over the Dengvaxia vaccine, which continues to be marketed and used in 10 other countries.

He also said there is no intent to downplay the risks of receiving the dengue vaccine if one had not been infected by the virus.

“There was no intent to downplay, there was an intent to clarify,” Triomphe said. “When we used the word ‘severe dengue,’ it’s not our choice. It’s the wording of severe dengue defined in the protocol of the clinical trial which was started in 2011.”

Triomphe said the word “severe” was too broad and constitutes different grades of classification.

He said Sanofi Pasteur is ready to “collaborate and reengage” with the Department of Health in contributing to the investigations to be done by the task forces on the review of the government’s dengue immunization program.

The World Health Organization yesterday advised member-states to limit the use of Dengvaxia to those previously infected with the dengue virus.

In a statement, the WHO said it is following the position of the Global Advisory Committee on Vaccine Safety based on the new evidence communicated by the vaccine’s manufacturer, Sanofi Pasteur.

“Dengvaxia prevents disease in the majority of vaccine recipients but it should not be administered to people who have not previously been infected with dengue virus,” said the WHO.

It noted how that latest findings of Sanofi Pasteur indicated an increase in incidence of hospitalization and severe illness in vaccinated children never infected with dengue.

Aside from limiting the target market for the dengue vaccine, the WHO said it is imperative for member-states that had approved the use of Dengvaxia to enhance its efforts to combat the disease.

President Duterte, on the eve of the testimony of former president Aquino in the Senate, said he has no plans of filing cases against former presidents.

Duterte said he would rather confront, or even shoot, political rivals for issues and misunderstandings rather than file a law suit.

Prior to his pronouncement, the President said he believed that the former administration undertook the dengue vaccine program in good faith.

Duterte said the program was implemented based on the information that the previous administration had and it was undertaken without knowledge that the latest controversy and questions about the safety of the Dengvaxia vaccine would surface. – With Jocelyn Montemayor and Gerard Naval
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