HSA okays use of Pfizer-BioNTech vaccine, will keep monitoring safety

Singapore is one of the first countries to obtain this vaccine. PHOTO: REUTERS

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

"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 which shows that the vaccine is effective for at least two months, with no signs of waning protection, HSA said.

The firms 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 in pregnant women and children.

"The companies must continue submitting the longer-term follow-up data to HSA to assure the continued effectiveness and safety of the vaccine," the authority said in a statement yesterday.

"HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh the known risks," it said, adding that it may terminate its use if, for example, the benefits no longer outweigh the risks.

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. "If all goes according to plan, we will have enough vaccines for everyone in Singapore by the third quarter of 2021," PM Lee said.

Britain was the first country to approve the use of the Pfizer-BioNTech vaccine on Dec 2. Since then, Canada, the United States and Mexico are among those that have also approved the use of this vaccine.

The approvals come after US pharmaceutical giant Pfizer and its German partner BioNTech released last month the final results from the late-stage trial of the Covid-19 vaccine.

The findings showed that their vaccine was 95 per cent effective in preventing a person from getting ill from the coronavirus.

This vaccine efficacy was observed to be consistent across different age groups 16 years and older in over 40,000 clinical trial participants, whose ages ranged from 16 to 91 years, said the HSA.

But the authority said certain groups of people, such as those with a history of anaphylaxis, or the rapid onset of severe allergic reactions, should not receive the vaccine as a precautionary measure.

Pregnant women, immunocompromised persons and those under the age of 16 should also not receive the vaccine as the safety and efficacy data on these groups of people is not available yet.

Read highlights of the announcements by PM Lee and the Covid-19 ministerial task force here.​

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A version of this article appeared in the print edition of The Straits Times on December 15, 2020, with the headline HSA okays use of Pfizer-BioNTech vaccine, will keep monitoring safety. Subscribe