Home National News Dengvaxia must get FDA's nod before reintroduction

Dengvaxia must get FDA’s nod before reintroduction

By Filane Mikee Cervantes

 

MANILA — Senator Richard Gordon on Thursday said the French manufacturer Sanofi Pasteur must first re-apply for a license for Dengvaxia with the Food and Drug Administration (FDA) before the government considers reintroducing the anti-dengue vaccine amid the rising number of dengue cases in the country.

Gordon said the controversial Dengvaxia must undergo some processes, including checks and balances in the government before it could be reintroduced for private and public use.

The Department of Health (DOH) stopped its massive dengue immunization program using Dengvaxia in late 2017 after Sanofi Pasteur said patients who had no prior exposure to the dengue virus were at risk of more severe dengue.

“We should make haste on this plan slowly. Sanofi should re-apply for an FDA license if the government will reintroduce the vaccine to fight the dengue epidemic that broke out in various parts of the country,” Gordon said.

“Though it was already given a license during the previous administration, the process by which the drug manufacturer got it was questionable,” he added.

He cited the old practice in the FDA wherein new drugs get a one-year provisional license, in which the company monitors several patients and is accountable and liable for any adverse effects.

He, however, noted that this requirement was suspended, which allowed Dengvaxia distributor Zuellig to get an outright five-year license without undergoing the one-year provisional license to take care of the required number of patients.

“We should tarry a little and make the vaccine undergo the proper process for licensing first. Let’s see if they can now comply with the requirements,” Gordon said.

“It was when the process was tampered that we got into trouble and made it worse for hundreds of thousands of vaccinees whose seroprevalence is unknown. I hope the DOH will not be politicized again and compromise its role as Sentinel of Public Health,” he added.

Last week, Presidential Spokesperson Salvador Panelo said if findings will show the benefits of using Dengvaxia against dengue, “then certainly the government should consider it”.

Panelo underscored the need to thoroughly investigate the safety and effectiveness of the controversial anti-dengue vaccine.

Panelo suggested after Iloilo First District Rep. Janette Garin appealed to the government to allow anew the use of Dengvaxia.

Garin was Health secretary when the government used Dengvaxia for the anti-dengue vaccination program of the administration of then-president Benigno Aquino III. (PNA)

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