MANILA, Philippines (UPDATED) – The Food and Drug Administration on Monday night, December 4, ordered the French pharmaceutical company Sanofi Pasteur to pull out its Dengvaxia vaccine from the market, "pending compliance with the directives of the FDA.”
Sanofi is also "immediately directed...to suspend the sale, distribution, marketing of Dengvaxia,” and to "conduct an information dissemination campaign through Advisories, Dear Doctor Letters and patient fora,” the regulatory agency said.
The FDA, which is under the Department of Health (DOH), issued the statement Monday, hours after Sanofi said in a press conference that while they had stopped the sale of the vaccine, there had been no product recall.
The drug company said suppliers had agreed to allow the company to inform health practitioners about the proposal for a new label to help their patients assess the risks and benefits of the vaccine.
FDA said, however: "In order to protect the general public, the [FDA] immediately directed Sanofi to...cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA."
Last Wednesday, November 29 Sanofi advised the public that clinical studies revealed the vaccine poses more risks for recipients who had no prior infection. (READ: Dengue vaccine more risky for people without prior infection – Sanofi)
In an update on its website at the time, Sanofi said: "The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.”
In a statement on Tuesday, December 5, Sanofi said they will work with the FDA to review the implementation of its order.
"We will continue to seek constructive and transparent dialogue with them," said Sanofi.
DOH, which purchased P3.5 billion worth of the vials in early 2016, said more than 700,000 Filipino youth have been given the vaccine under the government's mass immunization program. It said 70,000 of them are at risk of more severe types of dengue in about two years after getting the vaccine.
During Monday's press conference, Dr Ng Su Peing, global medical head of Sanofi, said the vaccine is not recommended for those without prior infection.
It also said there is no way of tracing who among the over 700,000 Filipino youth given the Dengvaxia vaccine are at risk from contracting severe dengue.
Asked whether Sanofi would shoulder the costs of individuals who might contract severe dengue after having received the vaccine, the company only said it is collaborating with the DOH and will continue to monitor cases.
"The FDA is closely coordinating with the [DOH] for any adverse events or reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public," the statement said.
It enjoined "all drug establishments, including consumers and non-consumer user (e.g. healthcare professionals)...to take part in the post marketing surveillance of Dengvaxia."
It urged citizens to report to the FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person. – Rappler.com