Tuesday, 28 June 2022

Singapore grants interim authorisation for Sinovac-CoronaVac vaccine

25 October 2021 | News

Persons who develop anaphylaxis or severe allergic reactions to the first dose of the vaccine should not be administered the second dose: HSA

image credit- shutterstock

image credit- shutterstock

The Health Sciences Authority (HSA) in Singapore has granted an interim authorisation under the Pandemic Special Access Route (PSAR) for Sinovac-CoronaVac, an inactivated SARS-CoV-2 vaccine developed by Chinese firm Sinovac Biotech, to be used for the prevention of COVID-19 in individuals aged 18 years and above. The application is for a vaccination regime that requires two doses of the vaccine to be administered 28 days apart.

HSA’s decision to grant PSAR interim authorisation for Sinovac-CoronaVac took into consideration that the vaccine met the minimum technical requirements for use during a pandemic, given the urgent public health needs. 

As PSAR is only an interim authorisation, the company is required to submit the complete dataset based on prevailing international standards to obtain a full registration. 

Also, as there was insufficient data on the use of Sinovac-CoronaVac in pregnant women, severely immunocompromised persons, persons with co-morbidities and those under the age of 18, no recommendations can be made by HSA for use in these sub-populations.

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