The Dengvaxia brouhaha

Note: The author, a senior partner of Accralaw, is part of the legal team assisting Sanofi.

Sanofi Pasteur (Sanofi), a world leader in the research, development and manufacture of human vaccines, made a breakthrough with the world’s first dengue vaccine. After over 20 years of rigorous research and development, Sanofi submitted for licensure its vaccine in 2015.

Since then, it has been used in over 11 countries, both in private and public markets in Asia and Latin America.

Based on the Department of Health’s (DOH) own Dengue Disease Surveillance Report, there has been a shocking increase in reported cases of dengue every year. In 2016, the government reported a staggering 220,518 newly reported cases and 1,092 deaths.

The facts speak for themselves: This serious public health concern requires immediate, sustained and efficient response from both private and public sectors.

Dengvaxia made its way to Philippine shores in 2016 after it was licensed by the Philippine Food and Drug Authority (FDA). Sanofi disclosed all scientific, pertinent and necessary information regarding the vaccine during the licensing process. The same information was disclosed to the World Health Organization (WHO) and the scientific community. The vaccine was first made available in the Philippine private market. The DOH eventually launched its P3.5-billion public health program to make the vaccine available and accessible to children from less fortunate families.

In late November 2017, Sanofi disclosed newly discovered information it learned through a new post-licensing analysis. It learned that seronegative persons (or those who have not been infected with dengue virus before vaccination, whether symptomatic or otherwise) have a 0.2-percent increased risk of getting traditional dengue symptoms such as fever, low platelet count, or nose bleeding categorized as DHF1 and DHF2 according to WHO 1997 severity classification. As for seropositive persons (those who have been infected with dengue before vaccination), the vaccine has a sustained protective effect for up to almost six years after vaccination.

In the wake of this disclosure, however, there has been a whirlwind of misinformation. Yet, it continues to be used in other countries despite the hullabaloo in the Philippines.

The public outcry here stems from misconception or a case of “lost in translation” regarding Sanofi’s disclosure. The report that, in the longer term, “more cases of severe disease could occur following vaccination upon a subsequent dengue infection” has been grossly twisted to suit the detractors’ selfish motives.

The reference to “severe disease” stems from the need to be consistent with the technical definitions contained and used in Sanofi’s clinical trials and reports. As clarified, the phrase does not mean there will be death or severe illness. It merely contemplates possible increase in the incidence of traditional symptoms of dengue.

To put things in perspective, in a country where 90 percent of the population is seropositive (many are likely unaware they have already had dengue before), there is only an extra 2/1000 chance of this increased risk of getting traditional symptoms of dengue—not shock, and definitely not death.

It appears our legislators expect a 100-percent safe or risk-free drug, when no such thing in the world exists—even aspirin!

The aftermath of this public confusion and outcry has resulted in the suspension and withdrawal of Dengvaxia.

It is a pity and a shame that the P2 billion already spent on the program may go to waste without us realizing its potential. From a legal perspective, will those responsible incur criminal liabilities for wasting public funds? Worse, will they be liable if the vast majority of our population who could have benefited from the vaccine suffer or die from dengue?