Wednesday, February 14, 2018

Sanofi and Zuellig Pharma were meant to support DOH in Dengvaxia program, but did they?

Sanofi and its Philippine distributor Zuellig Pharma Corp were obliged under the terms of its contract with the Philippine government to provide support to health workers, teachers and parents for its Dengue Vaccination Program.

Procurement documents obtained from the Department of Health under a Freedom of Information request lodged by this author reveal that as part of the purchase of Php3 billion worth of dengue vaccines, the manufacturer and supplier of the drug were meant to "conduct relevant training/orientation of health workers and teachers on the Dengue Vaccination Program" as well as "conduct orientation for parents, caregivers and students participating in the program".

Following the conduct of the mass vaccination of nine year old public elementary school children in Metro Manila, Central Luzon and Southern Tagalog regions, Sanofi and Zuellig were meant to provide support to DOH in developing a Dengue Vaccination Registry, and in conducting post-marketing surveillance, adverse effects following immunization (AEFI) response and related studies.

The French company was meant to support training on pharmacovigilance and Good Clinical Practice (CGC). In addition, the terms state that "the supplier shall be held liable in cases of adverse reactions due to impurities secondary to their negligence." These terms were accepted by a representative of Zuellig Pharma, who signed the document.

The question to be asked now is whether the support was adequately supplied. One would have thought that if proper guidelines had been established for undertaking the immunization in a safe manner, and if health workers, teachers and carers were properly informed of the risks associated with this new vaccine, that the misapplication of it could have been avoided.

Proper education and training about the groups at-risk of adverse reactions to the drug, namely seronegative children, or pupils who had not been previously infected with any of the strains of dengue, could have prevented the trauma suffered by families of these children. If in fact the terms of the contract were not upheld, then Sanofi and Zuellig should be held liable for their negligence. The source documents for this post are found below.


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