Dengvaxia maker denies it concealed ‘risks’

French pharmaceutical giant Sanofi Pasteur on Wednesday denied accusations it concealed from the Philippine government and public the risks of using its dengue vaccine Dengvaxia.

In a statement, the company lamented the “inaccurate information” that had come out on the transparency of data and findings related to Dengvaxia.

“Sanofi Pasteur would like to address the inaccurate information regarding the transparency of data and findings related to Dengvaxia. All our vaccines undergo extensive clinical investigations and their efficacy, safety and public health impact is continuously followed up post-license,” the company said.

Different product profile

In the case of Dengvaxia, the company said it had no information or data on the “serostatus of the vaccinees showing a different product profile in the population of 9 years old and above” from the time of its sale until November 2017.

The company said it learned about the different product profile of the dengue vaccine for those with or without a previous dengue infection only in November 2017.

Since then, Sanofi Pasteur claimed it had shared the new data in full transparency with national health authorities in countries where the vaccine is approved or where it is being considered for regulatory approval.

Meanwhile, Health Secretary Francisco Duque III announced that the Department of Health (DOH) planned to coordinate with regulators in Singapore.

Singapore regulators

Earlier, Food and Drug Administration (FDA) chief Nela Charade Puno said an FDA special task force’s review of Sanofi Pasteur’s papers showed the company informed regulators in Singapore of the vaccine’s risks.

“I think that’s part of the undertaking of FDA, to coordinate and to seek more information about the purported submission of Sanofi to the FDA of Singapore,” Duque said in a forum in Manila.

DOH shuffle

In a statement, Duque announced that he would shuffle senior DOH officials next week due to “ongoing investigations.”

He did not say, however, if the investigations were related to the Dengvaxia controversy or to allegations of corruption in the health department.

Duque said the shuffle would involve undersecretaries, assistant secretaries and directors.

He said the senior officials would be given new assignments “in order to preserve the integrity of ongoing investigations and to prevent any potential undue influence on their findings.”