Former DoH chief junked Sanofi deal

NEW vaccines should not be introduced to the market during an election year, said former Health secretary Paulyn Ubial while taking potshots at the P3.5-billion controversial Dengvaxia vaccine that was implemented under the administration of then Health secretary  Janette Garin and former President Benigno Aquino II.

“We do not introduce new vaccines during an election year,” said Ubial who failed to get the confirmation of the powerful Commisison on Appointments.

“Because no matter how good that vaccine is, the introduction during an election year would taint it. That’s why we can’t mix health and politics,” added Ubial, during the first Senate Blue Ribbon committee hearing on the dengue vaccine controversy.

AGAINST DENGVAXIA. Members of the Alliance of Health Workers hold a protest rally Monday at the Senate in Pasay City against Dengvaxia anti-dengue vaccine, the French pharmaceutical giant Sanofi Pasteur, manufacturer of the vaccine, and the Department of Health during a Senate hearing on the vaccine. Norman Cruz

Testifying in the hearing chaired by Senator Richard Gordon, Ubial said she was already against the use of the world’s first dengue vaccine for mass use in the Philippines when she was still assistant secretary.

Ubial said she strongly objected to the rollout of the government’s dengue vaccination program during her term in the Department of Health.

The vaccine program is now under scrutiny after the government purchased P3.5 billion worth of dengue vaccines from French pharmaceutical Sanofi Pasteur, which were later stopped by  Health Secretary Francisco Duque III.

Duque said 830,000 children were vaccinated with Dengvaxia but it was stopped after Sanofi announced that those vaccinated would suffer severe dengue cases if they had not yet been afflicted with the mosquito-borne ailment.

Ubial admitted it was hard for her to implement the vaccine program but said she had no choice because she was pressured to implement the government’s dengue vaccination program during her term.

“The pressure was there starting the first day that I became the secretary of Health,” said Ubial, adding that the vaccination program was given to nine years old and older.

She said she was ‘already on damage control.’

“People were telling me... I wanted to stop the next delivery because only 200,000 was delivered in March. The next delivery will be in August and in January. I wanted to stop that,” disclosed Ubial.

Last month, Sanofi Pasteur admitted that Dengvaxia could aggravate the disease in people who have not been afflicted previously by dengue.

But at the time of its admission, more than 733,000 public school children aged nine years old and above in Metro Manila, Central Luzon, and Calabarzon had already received three doses of Dengvaxia.

Ubial said that people, even in Congress, were telling her she would go to jail if she will not implement the program because there is a contract.”

“I dilly-dallied. That was intentional because of the issues that were raised by Dr. (Antonio) Dans and his team and Dr. (Anthony) Leachon,” said Ubial, referring to two members of an expert panel she formed to assess the dengue vaccine during her term.

“There were issues on long-term safety, and so I had to really be very, very careful, go the extraordinary mile, [take] extraordinary diligence for this program. And I’m glad I did it,” she added.

On July 18, 2016, Ubial signed a resolution recommending the deferment of the program, saying the vaccine is not proven safe.

She was criticized, however, for attempting to suspend the program. And so two months later, Ubial issued a Certificate of Exemption for Dengvaxia so it could still be used despite her earlier flagging on certain issues.

Howevever, Ubial said she intentionally delayed the implementation of the program in her efforts to save more Filipinos from possible risks of the vaccine.

She said the Philippines was a venue to clinical trials 10 years ago.

In the same hearing, Duque said he has instructed the Philippine Health Insurance Corp. to secure the necessary funding to provide assistance for dengue patients nationwide.

“I’ve also instructed PhilHealth to already make sure that the funding requirements for every child that has manifested or manifests this not only serious but not so serious symptoms,” Duque said.

“When they go to the hospital, PhilHealth must be ready to pay for their cost of hospitalization in the Amount of 10,000 [pesos] for ordinary and 16,000 [pesos] for severe cases of dengue,” said Duque.

He also urged the public not to lose its trust in vaccinations provided by the government amid the Dengvaxia controversy.

“Please don’t let this one event taint the innocence of the other vaccines because the other vaccines have been proven for decades of their protection and have really averted several hospitalizations,” he said.

Several parents have expressed their concerns regarding the Dengvaxia vaccines which was reported to possibly cause severe dengue among those injected who have not been affected by the strain earlier.

One of them, Iris Alpay, expressed dismay in past and current officials of the Department of Health.

“Sa mga taong behind this vaccine, especially former Secretary [Janette] Garin, gusto ko lang po ring tanungin sa kanya kung nakakatulog pa ba siya ng mahimbing kasi kami po ay hindi na,” she said during the Senate hearing.

Alpay’s child was one of the children inoculated against dengue with the Dengvaxia vaccine.

Alpay also expressed her disappointment on current government officials, as parents were not informed by the DOH regarding the recent development.

For his part, Health Secretary Francisco Duque III said he had called Alpay personally to address her concerns.

He also said the DOH has already formed a special committee to address concerns regarding Dengvaxia. It has also put up hotlines 711-1001 and 711-1002 specifically for dengue concerns.

In an interview prior to the hearing, former Health Secretary Janette Garin belied allegations of corruption and conspiracy in the procurement of P3.5 billion worth of Dengvaxia vaccines from Sanofi.

She said the procurement process was strictly followed by the government and that the documents will show that it is a long process.

“Talks started in 2010. Pinaigting ito nung 2012... It’s not a midnight deal. Everything was above board,” she said.

She supported officials of the Philippine Children’s Medical Center (PCMC) and clarified that they were not in connivance with regards to the  procurement of the vaccines.

“Let me categorically state that based on my personal knowledge and in the one and a half years that I’ve been working with them, I have never heard any question of integrity with regards to people and officials of PCMC,” she said.

Goron earlier raised a possible conspiracy in the procurement of the vaccines. He pointed out there were very, very strong signs of conspiracy.

The senator said there appears to be a conspiracy in the government’s procurement of P3.5-billion Dengvaxia vaccines from French pharmaceutical company Sanofi Pasteur because the budget for the procurement of the vaccine was not even part of the General Appropriations Act since there was no assurance yet that the vaccine was safe to be administered.

Gordon pointed out that with no less than former President Benigno Aquino III and Garin having had several meetings with Sanofi officials and each meeting resulting in the acceleration of the procurement process, suspicions that the procurement may have been supply-driven instead of needs-driven were fueled.

The senator said Garin’s May 2015 meeting with Sanofi Pasteur executives, though not irregular on face value, creates a circumstantial connection leading to irregularity. The government bought and rolled out the dengue vaccines from Sanofi in 2016, during the time of Garin as secretary of the Department of Health.

While Aquino may not have been invited to Monday’s hearing, Gordon did not clear him of any culpability in the dengue vaccine mess, considering his meetings abroad with Sanofi executives and the fact that the funds used for the procurement was realigned from the savings from Miscellaneous Personnel Benefit Fund pertaining to the DOH.

“To realign the budget without getting approval from Congress, only someone from higher up can order this. [Former Budget and Management secretary Florencio] Abad can’t walk 10 meters without the President knowing, especially with this kind of amount—P3.5 billion,” he said.

Meanwhile, Sanofi Pasteur, the makers of Dengvaxia, assured the public that it will fully cooperate with Philippine authorities in the ongoing Senate probe on the anti-dengue vaccination program.

Thomas Trioumphe, Sanofi Pasteur vice president for Asia-Pacific, told the Blue ribbon committee that the pharmaceutical firm stands by with its recent findings confirming the efficacy of Dengvaxia as an effective anti-dengue vaccine.

Trioumphe says that their firm has worked with Philippine health authorities for the past several years now and since then, has respected and followed Philippine regulatory policies.

Sanofi said it wants to assure Filipinos, especially parents, that Dengvaxia is a safe and effective vaccine for the prevention of dengue in highly endemic countries, such as the Philippines.

“The continuing long-term safety evaluation of the vaccine shows significantly fewer hospitalizations due to dengue in vaccinated vs. unvaccinated participants 9 years and older. The regulatory filing for the vaccine has been approved in 19 countries to date and launched in 11 of these countries.”

The vaccine which the company claimed has been the product of more than 20 years of research, is being used by several other countries in the global fight against dengue.

Aside from the Philippines, Brazil and Mexico, two countries with endemic dengue infestations, have availed of Dengvaxia, but only Brazil and the Philippines used Dengvaxia in their public health programs.

Sanofi added that results of its new analysis confirmed that the dengue vaccine provides persistent protective benefit against dengue fever, including hospitalizations and severe illness due to dengue for people with past dengue infections.

According to the Department of Health (DOH) in the Philippines, 9 out of 10 Filipinos are already infected with the dengue virus and most are asymptomatic, meaning not exhibiting or showing signs of infection.

Sanofi also clarified that, on the longer term, a trend of higher number of severe dengue cases in the indicated also compared to that un-vaccinated subjects, although it’s not statistically significant.

However, Sanofi confirmed that even for those without prior exposure, there has been no reported case of confirmed deaths or fatality related to the vaccine.

Sanofi Pasteur is currently working closely with the Food and Drugs Administration or FDA to update the current label for the vaccine to ensure that physicians can make appropriate vaccination decisions with their patients, maximizing the benefit of vaccinating people who had previous dengue infection against subsequent dengue infections and severe complications.

Topics: Dengvaxia vaccine
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