Former Health Secretary Janette Garin on Wednesday said patients and doctors should be allowed to procure Dengvaxia vaccine in light of the increase in dengue cases.
Interviewed on CNN Philippines, Garin, also Iloilo Representative, said the government should also reconsider its decision to revoke Dengvaxia’s certificate of product registration (CPR).
Dengvaxia manufacturer Sanofi announced in November 2017 that the vaccine posed a serious health risk to those who received the vaccine and were not previously infected by dengue. Sanofi’s announcement came after the vaccine has been administered to more than 800,000 children as well as some adults and policemen. Garin was then Health secretary during the Aquino administration.
Amid the controversy, Sanofi returned P1.16 billion to the DOH for the unused doses of Dengvaxia. “I am not saying that the government should buy it, but those parents who can afford it and want their children protected should be given the option to buy it,” Garin said.
The Department of Health (DOH) said over 64,000 dengue cases were recorded during the first six months of the year, a 90 percent increase compared with the same period last year.
The Philippine Food and Drug Administration revoked Dengvaxia’s CPR in February 2019 after it was linked to deaths of around 100 children who received the vaccine even if there were no concrete findings that it indeed caused these children’s deaths.
A product issued a CPR allows its manufacturers to sell their product commercially in the country. While the Philippines has shunned Dengvaxia, the World Health Organization has listed it under Essential Medicines List (EML), Garin said. She said governments are mandated to make those under EML available to its people at all times.
Garin said the revocation of Dengvaxia’s CPR in 2019 is not because of safety issues but purely an administrative requirement as the vaccine has yet to pass Phase 4 of clinical trials.
She argued that the entirety of Sanofi’s findings showed that the benefits of the Dengvaxia vaccine outweighed its risk.
“There is also a 90% reduction in deaths [due to dengue] and 83% reduction in severity. Hindi namamatay. Mas malamang ang benefits [The benefits are greater],” she added.
Dengvaxia, Garin said, is still being used in 23 countries. “If even a single death is attributed to a medicine or a vaccine, global regulations dictate that it would be immediately recalled. Ipagbabawal ‘yan [It will be banned],” she said.
A health reform advocate meanwhile has rejected the advice to re-evaluate the use of Dengvaxia vaccine despite a rise in dengue cases in the country.
Dr. Tony Leachon said the world’s first vaccine for dengue fever can’t re-enter the market due to “legal and regulatory impediments.”
The Food and Drug Administration (FDA) in 2019 revoked the certificates of product registration of Dengvaxia after Sanofi Pasteur failed to submit post-approval requirements.
Among post-marketing commitments that the French drug maker failed to submit are risk management plans, which are critical to public safety, Leachon said.
Dozens of lawsuits have been filed against health officials over claims the vaccine allegedly caused severe dengue symptoms in some recipients.
Instead of pushing the possible revival of Dengvaxia, Leachon said eradicating the breeding places of mosquitoes is still the most effective measure against dengue. He also called on massive clean-up of schools, workplaces and communities.
Leachon also warned that a renewed push of Dengvaxia “may dampen efforts of government to inspire people to do the boosters [for COVID-19].”
In a public briefing Monday, Dr. Rontgene Solante said it is “high time” for government to review the data and benefits of the Dengvaxia vaccine.
Latest data from the Department of Health showed the country’s dengue cases had nearly doubled compared to last year.
A total of 64,797 dengue cases were reported from January 1 to June 25, according to the DOH’s latest national dengue data as of June 25. The figure is 90 percent higher compared to the reported 34,074 dengue cases during the same period in 2021.
The increase in dengue cases can be attributed to higher mobility of the population and the onset of the rainy season.
The Philippines in 2016 became the first nation to use Dengvaxia in a mass immunization program.
But controversy arose after Sanofi disclosed a year later that it could worsen symptoms for people not previously infected by the dengue virus.
The disclosure sparked a nationwide panic, with some parents alleging the vaccine killed their children.