The FDA permanently revokes the registration of Dengvaxia


MANILA – The Food and Drug Administration has permanently canceled the product registration certificate for the Dengvaxia Dengue Vaccine, which has been criticized for declining vaccination rates.

The previous administration of Aquino had inoculated hundreds of thousands of schoolchildren the world's first dengue vaccine.

The French drug manufacturer Sanofi however revealed in December 2017 that the vaccine could trigger more serious symptoms for those who did not suffer from dengue, which prompted the government to stop the sale of Dengvaxia and its use as part of the state-run vaccination campaign.

The registration of Dengvaxia's product has been canceled due to Sanofi's continued inability to submit post-approval commitment documents, the FDA announced Tuesday.

"His uncompromising attitude to the FDA's directives and continued non-compliance leaves us no alternative but to impose the CPP's maximum penalty for revoking Dengvaxia's products," said the chief executive officer of the Dengvaxia. the FDA, Nela Charade Puno.

The revocation of the Dengvaxia CPR makes its importation, sale and distribution illegal, the FDA said.

The authorities do not agree on whether dengvaxia could have contributed to the deaths of several children.

This has resulted in a drop in immunization coverage in the country, falling to 40% last year, compared to an average of 70% in recent years.

Metro Manila and four other regions are currently experiencing outbreaks of vaccine-preventable diseases. measles.

Former President Benigno "Noynoy" Aquino III and several of his secretaries of cabinet have been charged with looting, embezzlement and corruption for their involvement in the Dengvaxia program.

The health committee of the House earlier this month also advisable the filing of criminal and administrative charges against officials.


Another dengue vaccine from Japan's Takeda Pharmaceuticals is in clinical trials, health secretary Francisco Duque III told ANC.

Takeda said last month that its experimental dengue vaccine appeared to be safe and effective in preventing the four types of mosquito-borne diseases.

The company said that no major safety concerns have been raised to date with the vaccine called TAK-003.

Takeda did not reveal vaccine results in people who had never been exposed to dengue fever before.

The company took blood samples from 20,000 children aged 4 to 16 from Asia and Latin America who participated in the Phase III TIDES trial. The study examined the safety and efficacy of the vaccine in children exposed to dengue fever and others.

Takeda said he would publish the details of the vaccine's reaction as soon as possible 15 months after the first dose in a peer-reviewed journal.

The vaccine is given in 2 separate doses of 3 months. The first results of effectiveness include 11 months of follow-up.

The second part of the trial, which includes an additional six months of patient data, will review how the vaccine is administered in each of the four types of dengue fever, as well as its performance according to the patient 's experience. previous dengue exposure and the number of participants who contracted severe dengue fever.

These two parts will form the basis of documents filed by Takeda for regulatory approval. A third part of the study will assess long-term safety by following the participants for another three years.

Dr. Rajeev Venkayya, President of Takeda's Vaccines Division, told Reuters the next publication would include preliminary data on vaccine performance against each strain of dengue fever and data on previous exposure of dengue subjects .

The first safety problems posed by the Sanofi vaccine did not appear until the third year after vaccination. After the Sanofi experiment, some experts believe that governments will need several years of monitoring data before integrating Takeda's vaccine into mass vaccination campaigns.

Venkayya does not speculate on the number of follow ups required by regulators or health authorities, but adds, "I think it will take more than a year."

Sanofi's vaccine was based on a yellow fever virus to which dengue genes were added, while TAK-003 is based on a weakened dengue 2 virus plus genes from the other 3 types of dengue fever. Some infectious disease experts believe that 100% dengue design could trigger a broader immune response.

With a Reuters report

Source link