Dengue Vaccine – Dengvaxia Update
Philippines Food and Drug Administration
FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)
04 December 2017
On 29 November 2017, Sanofi Pasteur, Inc. (Sanofi) released an advisory providing updated information on the Dengue Tetravalent Vaccine (Live, Attenuated), the drug locally registered as Dengvaxia. The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization.
In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to SUSPEND the sale/distribution/marketing of Dengvaxia and cause the WITHDRAWAL of Dengvaxia in the market pending compliance with the directives of the FDA. Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters and Patient fora.
The FDA is closely coordinating with the Department of Health (DOH) for any adverse events/ reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public.
All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to 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.
Sanofi ordered to pull Dengvaxia in Philippines as safety episode escalates
by Eric Sagonowsky | Fierce Pharma
Dec 5, 2017 9:15am
…In a Monday advisory, the Philippines’ FDA wrote that it directed Sanofi to “suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.”
The Philippines is the only country now conducting a Dengvaxia vaccination campaign. The effort is focused on areas within the country with high levels of dengue infection.
A Sanofi spokesperson told FiercePharma the company has been “informed of the position of the Philippine Food and Drug Administration … and will work with them to review the implementation of their direction. We will continue to seek constructive and transparent dialogue with them.”
The order comes right after Sanofi issued an advisory about the risks of the shot in recipients with no prior dengue infection. In those patients, the shot can cause more serious dengue infections. To get the word out, the regulators in the Philippines also ordered Sanofi to “conduct an information dissemination campaign,” with public advisories and communications with doctors and patients.
Based on data at hand, Sanofi estimated 1 in 800 dengue infections would be severe among unvaccinated people. In the new analysis of a five-year follow-up study, the increased risk translated to two more cases of “severe dengue” per 1,000 people who had not been exposed to the virus, the company’s spokesperson told FiercePharma. All recovered with treatment….
Philippines Orders Probe Into Vaccine, Sanofi Says No Deaths Reported
New York Times/Reuters | 3 December 2017
MANILA — The Philippines ordered a probe on Monday into the immunisation of more than 730,000 children with a dengue vaccine that has since been suspended, while French drug company Sanofi said no deaths had been reported as a result of the programme.
“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” Ruby Dizon, medical director at Sanofi Pasteur Philippines, told a news conference in Manila.
“Of course, rest assured, monitoring is continuing, we are working with the Department of Health (DOH), in collaboration, to make sure this is maintained.”…
Dengue Vaccine – Dengvaxia Update