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How India narrowly escaped a health crisis

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December 05, 2017 17:06 IST
The Philippines launches probe after Sanofi reveals WHO-approved dengvaxia - a dengue
vaccine - aggravates symptoms in some cases.

The delay by the health ministry in approving the sale of the first-ever dengue vaccine developed by
French pharmaceutical major Sanofi Pasteur might seem like another case of red tape, but the health
crisis unfolding in the Philippines shows that India might have narrowly avoided a disaster.

The World Health Organization (WHO) had approved Sanofis dengue vaccine dengvaxia in April last
year; the Philippines became the first nation to widely distribute it, after fast-tracking the approval

Several other countries such as Mexico, El Salvador, and Brazil have approved its sales.

On Monday, however, the Philippines launched an investigation after suspending the dengue vaccine
last week, reported The Wall Street Journal.

The suspension came after the drug manufacturer said new evidence showed the vaccine could
worsen dengue symptoms in some cases.
More than 730,000 people, mostly children aged about nine or more, were given the vaccine in the

This had led to a crisis in the country, with Philippiness presidential spokesman Harry Roque saying
Manila vowed to leave no stone unturned in making accountable those responsible for this
shameless public health scam.

The resistance from the health ministry in India came despite dengue cases rising to 0.14 million in
2017 (provisional data till November 26) from 0.12 million in 2016, according to the data from the
National Vector Borne Disease Control Programme.

There have been 221 deaths in India from dengue in 2017, against 245 the previous year.

This vaccine has been pending with us for two years. We do not plan to approve it till we are
satisfied, irrespective of what other drug regulators do, said G N Singh, drug controller general of
India (DCGI).

The company had sought a clinical trial waiver. We need to evaluate such requests. But, we will not
approve any vaccine without being satisfied with the quality and efficacy.

A person can be infected with dengue as many as four times due to the existence of different strains.
Subsequent infections are often more severe.

Sanofi said last week new data found the vaccine was effective for people who had already had
dengue, but for those who hadnt, more cases of severe disease could occur following vaccination.

The company said it had asked regulators to change the vaccine label to recommend not taking the
vaccine if people had not been previously infected.

The rising menace of the dengue has led domestic vaccine maker Serum Institute of India to plan
launching a dengue vaccine in three to four years, besides a biologic drug for dengue in the next
couple of years.

Dengvaxia was the first of its kind, targeting a mosquito-borne disease that afflicts some of the worlds
poorest countries.

Dengue infects about 390 million people a year globally, 96 million of whom require treatment,
according to the WHO.

Of those, about half a million are admitted to hospitals, and 2.5 per cent of all cases are lethal.

The virus causes a severe flu-like illness marked by painful joints and extreme fatigue.

Photograph: Robert Pratta/Reuters

Abhineet Kumar & Veena Mani in Mumbai / New Delhi