By The Pulseline News Desk
Sri Lanka’s National Medicines Regulatory Authority (NMRA) is awaiting a post-vaccination monitoring plan from the company importing a dengue vaccine before proceeding with the next steps towards its use in the country, raising questions over how recipients will be monitored after receiving the newly registered vaccine.
NMRA Chairperson Dr Ananda Wijewickrama has said the authority had decided to grant registration to the vaccine on a one-to-one basis, but the importing company was yet to submit the required details on how people receiving the vaccine would be followed up.
Dr Wijewickrama has told a daily English newspaper that the NMRA had requested a proper monitoring mechanism to track recipients and assess their condition if they subsequently contracted dengue.
“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 has said.
According to Wijewickrama, the company had been asked to explain how post-vaccination follow-up would be conducted, but the NMRA had not yet received the necessary information.
He has stressed that responsibility for submitting the proposed monitoring arrangements rested with the company importing the vaccine and that the process could not proceed without the required details.
The authority’s position highlights the importance of establishing a mechanism to monitor the safety and effectiveness of a newly registered vaccine, particularly in assessing outcomes among recipients who develop dengue after vaccination.
Private-sector use approved
Health Ministry Secretary Dr Anil Jasinghe, meanwhile, has said approval had been granted for the dengue vaccine to be used in the private sector.
Those wishing to obtain the vaccine could do so, he has said.
His remarks indicate that private-sector use has received approval, although the NMRA is still awaiting the importing company’s post-vaccination monitoring plan before taking further steps in the process.
The distinction between registration, authorisation for private-sector use and the implementation of post-vaccination monitoring remains important as the authorities address the requirements associated with introducing the vaccine in Sri Lanka.
The proposed monitoring mechanism is expected to clarify how recipients will be followed up and how cases of dengue occurring after vaccination will be assessed.
Until the required information is submitted, the NMRA’s next steps will depend on the importing company’s response.
Leave a comment