With the government studying proposals to reintroduce the controversial Dengvaxia to the market after the Department of Health recorded more than 130,00 dengue cases as of mid-July, Senator Richard J. Gordon proposed for the vaccine's French manufacturer Sanofi Pasteur to first re-apply for a license for the vaccine from the Food and Drug Authority.
Gordon pointed out that new vaccines have to undergo some processes, including checks and balances in the government before they could be introduced for private and public use and Dengvaxia has to first go through all these. This, he added, considering Sanofi's statement in 2017 that Dengvaxia could only be used in people who have previously has a dengue infection as there was evidence that it may worsen subsequent infections if given to people who had no previous infection.
"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. Though it was already given a license during the previous administration, the process by which the drug manufacturer got it was questionable," he stressed.
The old practice in the FDA was that new drugs get a one year provisional license during which time the company monitors a number of patients and is accountable and liable for any adverse events. However, Dr. Kenneth Hartigan Go suspended this requirement which paved the way for 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.
Gordon noted that the Formulary Executive Council was also railroaded into giving an approval, although it recommended that it be done in a stage procurement and advised the government not to buy the vaccine in bulk. However, the recommendations were not followed when the government procured one million vaccines and proceeded to conduct a mass inoculation in various schools in several regions in the country.
"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. It was when the process was tampered that we got into trouble and in fact made it worst 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 said.
Source: Senate of the Philippines