More information needed on Sinovac's COVID-19 vaccine before decision on PSAR approval: Kenneth Mak

SINGAPORE: The Health Sciences Authority (HSA) has made "additional requests for more information" about China's Sinovac COVID-19 vaccine and is still completing its review of the vaccine, the Ministry of Health's (MOH) director of medical services Kenneth Mak said on Friday (Sep 17).

Responding to a question at a multi-ministry task force doorstop, Associate Professor Mak said: "They (HSA) had previously made some requests for additional information to be contributed from the manufacturers, the manufacturers had given additional information in. 

"But then, I understand that there have been some additional requests for more information, and that process of collaboration between the manufacturer and HSA continues."

After its review, HSA will provide a recommendation as to whether the Sinovac COVID-19 vaccine can be granted Pandemic Special Access Route (PSAR) approval.

Assoc Prof Mak was responding to a reporter who asked for an update on HSA's review process of the Sinovac vaccine, as it has been "more than two months" since the authority got the additional information it initially asked for.

HSA told CNA in March that it had started reviewing data on the Sinovac vaccine, although it still needed more information to assess if the vaccine can "meet the required standards for quality, safety and efficacy" for authorisation under PSAR.

The Pfizer-BioNTech and Moderna vaccines are the only vaccines approved in Singapore under PSAR. Pfizer-BioNTech and Moderna's vaccines are both mRNA vaccines, while Sinovac's vaccine uses an inactivated virus.

Both mRNA vaccines are used in Singapore's national vaccination programme.

In June, Sinovac's COVID-19 vaccine was approved for use in Singapore under a different Special Access Route (SAR), after it was approved for emergency use by the World Health Organization (WHO).

The SAR allows private healthcare institutions to bring in unregistered COVID-19 vaccines. These vaccines must be on WHO's emergency use listing and they include the ones from Johnson & Johnson, AstraZeneca and Sinopharm. 

Sinovac said on Wednesday that it will supply Singapore with another 101,000 doses of its vaccine.

Health Minister Ong Ye Kung said on Friday that the new Sinovac stock is expected to arrive in Singapore around Monday, before being distributed to clinics.

"We remain hopeful that once HSA completes its process, we might see HSA coming to a firm decision and giving us a recommendation as to whether or not the PSAR approval can be granted then to the Sinovac vaccine," Assoc Prof Mak said.