Sanofi has been through an ordeal with its Dengvaxia rollout in the Philippines, but earlier this month, it looked as if officials might reintroduce the dengue vaccine to battle a deadly outbreak. For now, though, that's off the table.
This week, the country’s Department of Health upheld an earlier decision that revoked Sanofi’s certificates of product registration based on the company’s failure to “submit post-approval requirements.”
In this review, officials weren’t even looking at Dengvaxia’s efficacy. The decision “concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” health secretary Francisco Duque III said in a statement. Sanofi had filed an appeal in a bid to get the vaccine back on the market.
Officials aren’t fully closing the door on Dengvaxia, though. The agency said Sanofi may seek a new approval if it complies with the country’s laws. This time, though, Sanofi failed to live up to its post-marketing commitments, officials said.
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The Philippines declared a “national dengue epidemic” this month amid an outbreak that has killed at least 622 people. Officials have tracked 146,062 cases from January to July 20, a 98% increase over the same period last year.
The country was among the first to approve and launch Sanofi’s Dengvaxia, but after the company in 2017 reported the shot can cause more serious infections if given to people who haven’t had a prior infection, a scandal ensued. Officials quickly called off vaccinations and struck up investigations. Authorities later pulled the vaccine from the market completely.