Interim authorisation of Moderna COVID-19 vaccine for active immunisation to prevent COVID-19 disease in Singapore
The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and Panel of Infectious Diseases Experts, would like to inform healthcare professionals on the interim authorisation of Moderna COVID-19 Vaccine under the Pandemic Special Access Route (PSAR) for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals 18 years of age and over.
This is the second COVID-19 vaccine to be granted interim authorisation under PSAR*. HSA’s interim authorisation is based on the totality of evidence from the quality, non-clinical and clinical data available to date.
The efficacy of the Moderna COVID-19 vaccine is based on clinical data from the Phase III COVE study, where a total of 30,351 subjects (aged 18 to 95) were randomised to receive either the vaccine or placebo. The results to date showed that the vaccine, when given as a two-dose regimen 28 days apart, achieved 94.1% (95% CI:89.3%, 96.8%) efficacy for the prevention of symptomatic COVID-19 disease as compared with placebo.
The safety analysis comprised data from > 15,000 subjects who had received ≥ one dose of the vaccine. The most common solicited adverse reactions were injection site reactions, fatigue, headache, muscle pain, joint pain, chills, nausea / vomiting and fever.
HSA will continually review the regulatory recommendation as data from on-going clinical and manufacturing studies become available. The company will be required to submit ongoing data to HSA to ensure the continued efficacy and safety of the vaccine. Healthcare professionals are required to report any suspected serious adverse events related to the Moderna COVID-19 vaccine to HSA as soon as possible. In view of the availability of two vaccines for prevention of COVID-19 disease, healthcare professionals are required to specify the brand name and batch number of the vaccine when submitting the notification on COVID-19 vaccinations to the National Immunisation Registry, as well as when reporting suspected adverse events to HSA. HSA will actively monitor the adverse events associated with the vaccine and keep healthcare professionals informed should there be any significant safety signals.
Please refer to the Dear Healthcare Professional Letter (DHCPL) for details.
* PSAR <https://www.hsa.gov.sg/hsa-psar
Dear Healthcare Professional Letters