A WORLD-FIRST dengue vaccination program in the Philippines that was suspended over safety concerns will not cause anyone who was immunized to die, drug manufacturer Sanofi and local authorities said on Monday.
The Philippines on Friday suspended the program, after more than 733,000 people had been immunized, in response to a statement from Sanofi that its vaccine could cause “more cases of severe disease” for people who had not previously had the mosquito-borne ailment.
After news outlets and some politicians in the Philippines expressed concern about the welfare of those immunized, the French pharmaceutical giant held a press conference in Manila to state the potential cases of “severe dengue” would not be fatal.
“What is this severe [dengue]? When people think of ‘severe’, this already includes dengue shock that could lead to death, but no,” Sanofi Pasteur regional head for dengue Joselito Sta. Ana told reporters.
Sta. Ana said Sanofi’s definition of “severe dengue” merely referred to symptoms including two days of fever, a lower platelet count and bruising.
Presidential spokesman Harry Roque also sought to allay fears, stating there was “no danger” with the Dengvaxia vaccine.
“The worst that can happen is for those who have not had dengue before—which is one out of 10 [Filipinos]—they may get infected with dengue but falling under our previous classification of ‘mild,’ having fever and bruises,” Roque said.
Nevertheless, the Justice Department announced Monday that the National Bureau of Investigation would investigate the vaccination program “over the alleged danger to public health.” It warned in a statement that charges could follow.
The previous administration of President Benigno Aquino III launched the vaccination program last year, making the Philippines the first nation to use Dengvaxia on a mass scale.
Although the Philippine program has been suspended, Dengvaxia remains available on an individual basis in consultation with doctors, the Health Department said.
At the press conference, Sta. Ana denied suggestions that thousands of Filipinos were not used as guinea pigs.
“The Department of Health program is a public health program, not a clinical trial, so Filipinos were not used as guinea pigs,” Sta. Ana said.
Sta. Ana also said nine out of 10 Filipinos are exposed to dengue by the time they reach adolescence but only three-fourths of the cases are asymptomatic.
Officials of the drug firm said there have been no reported deaths in the Philippines related to the program, which was put on hold pending government’s review of the health project.
Sanofi general manager Ching Santos said the vaccine has gone through rigorous tests for over 20 years. She added their children also took the vaccine.
Santos said the company will also cooperate with the Departments of Justice, and Health officials and the National Bureau of Investigation with the pending probe in connection with the P3.5-billion dengue program.
“In line with that, well of course [Sanofi] is a very responsible company, we are transparent. If we will be invited, we will present whatever data we had presented to the stakeholders, the Food and Drug Administration, and the DoH. Of course we will cooperate,” she said.
The giant pharmaceutical firm based in France will ask health authorities to update information provided to physicians and patients on Dengvaxia in countries where it is approved.
The request is based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.
Based on up to six years of clinical data, the new analysis evaluated long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not.
The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.
“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries.” said Dr. Su-Peing Ng, Global Medical head, Sanofi Pasteur.
About half of the world’s population lives in countries where four serotypes of dengue virus are in circulation. Every year an estimated 390 million dengue infections are reported.
Sanofi stated that people can be infected with dengue up to four times in their lifetime and they can get severely ill after any of these infections. It added that surveillance data from some endemic countries indicate that between 70 and 90 percent of people will have been exposed to dengue at least once by the time they reach adolescence.
The firm also said there are many factors that can lead to severe dengue infection. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus.
Dengvaxia is currently indicated in most of the countries for individuals 9 years of age and older living in a dengue-endemic area. In this indicated population, Dengvaxia has been shown to prevent 93 percent of severe disease and 80 percent of hospitalizations due to dengue over the 25-month phase of the large-scale clinical studies conducted in 10 countries in Latin America and Asia where dengue is widespread.
Based on the new analysis, Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that health care professionals assess the likelihood of prior dengue infection in an individual before vaccinating.
Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.
The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration. Following their review, each agency might amend the company proposed label.
Dengue is a painful, debilitating mosquito-borne viral disease for which there is no treatment. Almost 4 billion people are living at risk of dengue and these people can be sickened by dengue not just once but as many as four times in their lifetimes.
The World Health Organization has called on countries with dengue to employ an integrated approach to dengue prevention and management, with the aim of reducing deaths due to dengue by 50 percent and related disease and disability by 25 percent by 2020.
In the Palace, Roque said the 700,000 who have been inoculated were not in danger.
“The good news is people should not panic about the dengue vaccine. There is no danger with the dengue vaccine,” Roque said in a news briefing at Malacañang.
Roque echoed the assurance of Sanofi that for those who already had contact with dengue, which represents nine out of 10 Filipinos, the dengue vaccine “is in fact very effective in protecting the patient from another attack of dengue.”
“The only new finding that they have is that for the one person out of 10 who’s not had dengue, chances are after three years, he may still be afflicted with dengue which was classified as ‘severe dengue’,” he said.
In the same briefing, Health Assistant Secretary Lyndon Lee Suy said that those 10 percent “at risk” will not automatically develop the disease for simply being vaccinated.
“You may develop [it]. You may be at risk. But [we are] not saying that [that] one out of 10 would eventually develop severe dengue,” Lee Suy said.
Amid calls to probe on the purchase of the Dengvaxia vaccine by the previous administration, Roque said the administration is already taking steps to determine the culpability, if any, of those responsible for the procurement of the vaccine.
“If there are any irregularities, we will find out. If there are irregularities, then the President has said that he will take action,” he said.
Senate President Pro Tempore Ralph Recto said the government must assure the public that the vaccines that it will procure by next year for P7.4 billion will meet the highest standards.
“Whether we like it or not, one side effect of this unfortunate incident is that people are asking if the vaccines to be bought using taxpayers money are safe,” Recto said.
“I know that they are, but the DoH must still go out of its way in assuring the public that next year’s vaccines meet the highest standards,” he added.
In contrast to the Health Department assurances, the leader of a watchdog group said in a press conference that three children who were immunized with Dengvaxia died in Region 3.
Roque said people should not get ahead of the investigation of the Justice Department.
“Let the DoJ conduct its investigation,” he said. “Then we will do what is necessary.”
