Singapore is First in Asia to Approve Moderna’s Covid-19 Vaccine
The Health Sciences Authority (HSA) has announced that it has granted an interim authorisation today under the Pandemic Special Access Route (PSAR) for the Moderna Covid-19 vaccine to be used for people aged 18 years and above in Singapore. It is the second Covid-19 vaccine to be granted interim authorisation under PSAR.
The first shipment is expected to take place in March.
In a press statement on February 3, HSA said the vaccination regime submitted by Moderna requires two doses of vaccine to be administered 28 days apart.
HSA’s review of the available clinical data found that the benefits of the Moderna Covid-19 vaccine outweigh the known risks and it demonstrated a high vaccine efficacy of 94 per cent.
This means that there is a 94 per cent reduction of symptomatic Covid-19 disease in a vaccinated group of people as compared to a similarly sized group of unvaccinated people. This vaccine efficacy was based on a Phase III clinical trial conducted in over 30,000 clinical trial participants whose ages ranged from 18 to 95 years.
HSA reviewed data from pre-clinical studies, clinical trials in human volunteers, and manufacturing and quality controls. Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts, comprising medical doctors and infectious diseases specialists, were consulted during the review to ensure that the vaccine is safe, efficacious and of good quality based on the data submitted to-date, and that the benefits outweigh the known risks for the Singapore population.
HSA also noted that as with all vaccines, there will always be a small proportion of susceptible persons who experience severe allergic reactions upon vaccination. They include those with a history of anaphylaxis (i.e., rapid onset of severe allergic reactions) or severe or multiple allergies to medicines and food. Immediate medical attention should be sought if such cases arise.
Speaking in Parliament on February 1, Senior Minister of State for Health Janil Puthucheary said there have been four reported cases of anaphylaxis in people who received the first dose of the Pfizer-BioNTech vaccine.
To date, more than 155,000 people in Singapore have received at least the first injection of the two-dose Pfizer-BioNTech vaccine.
Dr Choong May Ling, Mimi, Chief Executive Officer of HSA shared: “HSA has applied the same rigorous evaluation processes, as with all vaccines, to ensure that the Moderna Covid-19 vaccine has met the required high standards of quality, safety and efficacy.
“Our Medicines Advisory Committee and Panel of Infectious Diseases Experts have supported HSA's recommendations to grant interim authorisation to the Moderna Covid-19 vaccine. HSA's evaluators will continue to conduct rigorous and efficient assessments to facilitate Singapore’s access to critical Covid-19 vaccines and medicines to support our nation’s battle against the Covid-19 pandemic.”