MOH: Healthcare regulators conduct further evaluations for vaccines on WHO emergency use list

The WHO Emergency Use List focuses on the needs of low- and middle-income countries with limited access to Covid-19 vaccines.

Sulaiman Daud | June 04, 2021, 11:05 PM

The Ministry of Health (MOH) released a statement on the night of June 4, explaining why the Sinovac vaccine from China has not yet been approved as part of Singapore's national vaccination programme.

It noted that some Singaporeans have been asking why the approval has not been automatically granted by the Health Sciences Authority (HSA), following the World Health Organization's (WHO) decision to approve the emergency use of Sinovac for adults, or its Emergency Use List (EUL).

MOH said:

"We would like to clarify that the WHO EUL pathway focusses on the needs of low- and middle-income countries with limited access to COVID-19 vaccines.

It is a risk-based process that expedites the assessment of vaccines for use in a pandemic especially in these countries, where the benefits are deemed to outweigh the risks, despite uncertainties about the safety and efficacy of the vaccine.

Healthcare regulators in many developed jurisdictions, including Singapore, typically conduct further rigorous evaluations beyond WHO EUL approval before approving a vaccine for general use."

As MOH has the Sinovac vaccine in stock, it will be inviting private healthcare institutions licensed under the Private Hospitals and Medical Clinics Act to apply to be licensed providers for Sinovac under the Special Access Route, and draw on Singapore's existing stock of 200,000 doses.

Private healthcare institutions who are keen to apply to the licensed providers MOH's existing stock of 200,000 doses of Sinovac can apply at https://go.gov.sg/zue5s4 from today onwards, MOH said. The application will close by June 11, 2021, 12pm.

Reimbursement for some people

MOH noted that some people with allergies or anaphylaxis may not be able to take the mRNA vaccines, and may want to apply for Sinovac under the Special Access Route. It said:

"The vaccines from our current stock will be released for free to successful providers. Providers will be allowed to charge patients receiving the vaccine a fee to cover their costs.

For the 34,000 individuals who were previously rejected from taking the mRNA vaccines or who were allergic to the mRNA vaccine, the government will reimburse them this fee if they decide to receive Sinovac-CoronaVac. Details will be made known to these individuals in the coming week."

Evaluation by HSA still ongoing

MOH added that HSA evaluates all applications, regardless of their country of origin, based on the same standards and requirements.

HSA is still awaiting outstanding data on the Sinovac vaccine from Sinovac for it to complete its independent and thorough evaluation of the quality, safety and efficacy of the vaccine for inclusion in Singapore's national vaccination programme.

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