• NMRA requests post-jab monitoring plan
• Registration to be granted on one-on-one basis 
• Commercial interest wanes
• Importer yet to provide requisite follow-up info

The National Medicines Regulatory Authority (NMRA) is awaiting a post-vaccination monitoring plan from the company responsible for importing the dengue vaccine before the next steps can be taken towards its use in Sri Lanka, NMRA Chairperson Dr Ananda Wijewickrama said yesterday (15).

Speaking to The Daily Morning, Dr Wijewickrama said the NMRA had decided to grant registration to the vaccine on a one-to-one basis, following which the commercial interest surrounding the matter had subsided.

“Since this is a new vaccine, we informed the company that a proper mechanism must be in place to monitor people who receive it. We need to know how recipients will be followed up, including what happens if they contract dengue after vaccination and whether their condition becomes less or more severe,” he said. Dr Wijewickrama said that the company had been asked to explain how such follow-up would be carried out, but the NMRA had not yet received the required information. He stressed that the responsibility lay with the company importing the vaccine, which must provide details of the proposed monitoring mechanism before the process could proceed.

Health Ministry Secretary  Dr Anil Jasinghe, when contacted for comment, said that approval had been given to the dengue vaccine to be used in the private sector. Those who want can obtain it, he added.