HSA to keep monitoring Pfizer-BioNTech vaccine to ensure it is safe

After approving the Pfizer-BioNTech Covid-19 vaccine yesterday for use in Singapore, the Health Sciences Authority (HSA) said it will keep monitoring the vaccine to ensure that it continues to be safe.

"We will draw on our network of healthcare professionals and international regulatory counterparts, as well as use data analytics to enable us to detect early safety signals," said Associate Professor Chan Cheng Leng, group director of HSA's health products regulation group.

"This will enable HSA to take swift regulatory actions should any safety concern emerge."

For instance, as a condition for the interim authorisation, HSA said Pfizer and BioNTech are required to monitor the longer-term efficacy of the vaccine to determine the duration of protection against Covid-19.

This will supplement the available data that shows the vaccine is effective for at least two months, with no signs of waning protection, HSA said.

They must also follow up on the safety of the vaccine for a longer period to determine its full safety profile and study the safety of the vaccine in sub-populations such as pregnant women and children.

The first shipment of the vaccine is expected to arrive here by the end of this month, Prime Minister Lee Hsien Loong said yesterday.

This makes Singapore one of the first countries to obtain this vaccine, he added. Other vaccines are expected to arrive here in the coming months. - THE STRAITS TIMES