Singapore’s Health Sciences Authority (HSA) has granted interim authorisation for the Moderna Covid-19 vaccine to be used here under the Pandemic Special Access Route (PSAR).
In a release, HSA revealed the vaccine is approved for people 18 years old and above, and the vaccination regime submitted by Moderna requires two doses of vaccine to be administered 28 days apart.
This is slightly different from the Pfizer-BioNTech vaccine, which is approved for people 16 years old and above and requires two doses administered 21 days apart.
Singapore's Health Ministry (MOH) said it will progressively roll out the Moderna vaccine when shipments of the vaccine arrive and "expects the first shipment to arrive around March 2021, if there are no disruptions to the shipment schedule."
HSA’s review of the available clinical data found that the benefits of the Moderna vaccine outweigh the known risks, and demonstrated a high vaccine efficacy of 94%.
Based on the data accrued from clinical trials to-date, the safety profile of the Moderna vaccine was “generally consistent with other registered vaccines used in immunisation against other diseases.” HSA noted.
Some common side effects that vaccine recipients may experience include pain, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting, and joint pain after vaccination.
However, HSA said these symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response so as to build immunity against Covid-19, and will usually resolve on their own within a few days.
SEE: Pfizer to deliver US vaccine doses by end May
The Authority also highlighted that there will be a small proportion of susceptible persons who experience severe allergic reactions upon vaccination. They include those with a history of anaphylaxis or severe or multiple allergies to medicines and food.
Therefore, as a precautionary measure, HSA advised anyone with a history of anaphylaxis or severe or multiple allergies to medicines or food should not receive the Moderna vaccine.
Pregnant women, severely immunocompromised persons and those under the age of 18 should also not receive the Moderna vaccine as the safety and efficacy data for these groups of individuals are not available yet.
Those who develop anaphylaxis or severe allergic reactions to the first dose of the vaccine also should not receive the second dose.
Under PSAR, Moderna is required to monitor the longer-term efficacy of the vaccine to determine the duration of protection against Covid-19.
HSA will also actively review the data submitted by Moderna to ensure that the benefits of the vaccine continue to outweigh the known risks.
When sufficient data is available for full registration, Moderna will then be required to file an application to transit the status of the product from PSAR interim authorisation to full registration.
HSA said it may terminate PSAR authorisation at any time; for example, if new data suggest that the benefits no longer outweigh the risks.
As of Feb 2, MOH disclosed that more than 175,000 people have received their first dose of the Covid-19 vaccine.
About 6,000 of them have also received their second dose of the vaccine and completed the full vaccination regimen.
