Expert group asks Duterte to wait for vaccine review before using Sinovac donation

Sofia Tomacruz
Expert group asks Duterte to wait for vaccine review before using Sinovac donation

EMERGENCY USE. An employee inspects vials containing CoronaVac, Sinovac Biotech's vaccine against the coronavirus disease (COVID-19), at Butantan biomedical center in Sao Paulo, Brazil, January 12, 2021.

File photo by Amanda Perobelli/Reuters

Medical experts say the Health Technology Assessment Council's review is necessary because it considers the ethical, legal, social and health system implications of using a vaccine for a public health program

Several of the Philippines’ top health experts urged the Duterte government to wait for the review of the country’s Health Technology Assessment Council (HTAC) before using donated Sinovac vaccines expected to arrive in the Philippines in the next few days. 

The country’s largest coalition of health groups and frontliners, the Healthcare Professionals Alliance Against COVID-19 (HPAAC), made the call after the Philippines’ Food and Drug Administration (FDA) granted emergency use authorization for Sinovac’s COVID-19 vaccine – with the recommendation that it not be used on health workers with high exposure to the disease. 

FDA Director General Eric Domingo said its lower efficacy of 50.4% from trials in Brazil led experts not to recommend its use in the priority sector. The Brazil trials involved health workers exposed to COVID-19.

The agency instead recommended its use among 18-59 year olds after separate Phase 3 trials in Indonesia and Turkey demonstrated an efficacy of 65.3% to 91.2%. These trials were done mostly in community settings and not among health workers who were exposed to COVID-19.

HPAAC said the limitation raised a “quandary on who should be prioritized to receive the 600,000 donated doses of Sinovac.” “Should it be the healthcare workers who are first on the list of the National Vaccine Prioritization Program or should it be other groups deemed more suited for the same by FDA?,” the group said in a statement on Wednesday, February 24. 

“HPAAC is of the opinion that the only way to break this dilemma is to subject Sinovac to the health technology assessment process in accordance with law,” they group added. 

What’s the HTAC?

The HTAC, created by the Universal Health Care Law, is a group of experts tasked with the unique role of reviewing any health technology, including vaccines and medicines, to be used for public health programs. 

The group said it was essential to wait for the HTAC’s review since the body is mandated to “adhere to the principles of ethical soundness, inclusiveness and preferential regard for the underserved, evidence-based and scientific defensibility, transparency and accountability, efficiency, enforceability and availability of remedies and due process.” 

Aside from this, other factors the HTAC considers in its assessment include the feasibility and cost-efficiency of medical technology like vaccines for use in public health programs, as well as potential commercial or political conflicts of interest. 

The HTAC’s recommendation was still necessary for donated vaccines, HPAAC said, because “HTAC deliberations does not solely focus on cost minimization issues for the State, but also include “ethical, legal, social and health system implications.” 

“Foreign donated technology during pandemics and emergencies must still undergo technical appraisal by HTAC in order to determine their clinical and economic value,” they said.

Required step

Waiting for the review and recommendation of the HTAC won’t be unique to Sinovac. The HTAC had also reviewed Pfizer and AstraZeneca after it secured emergency approval for its vaccine. 

But where Sinovac’s findings led the FDA to issue a recommendation on its use, Pfizer and AstraZeneca had no such limitation. The urgency of an HTAC review was also not necessary as doses of its vaccines have yet to arrive in the country before the group finished its assessment. 

In contrast, doses of Sinovac’s vaccine were scheduled to arrive in the Philippines in a matter of days, making it the first vaccine likely to arrive in the Philippines despite being the last among the 3 to be granted an EUA. The timing of the vaccines arrival followed delays in the delivery of Pfizer and AstraZeneca’s vaccines from the COVAX global facility due to paperwork and limited global supply. 

HPAAC urged the Duterte government to apply the same standard for Sinovac’s vaccine. 

The group said, “We are confident that HTAC shall formulate these recommendations with judicious haste. We just need to ensure that they will not be unduly influenced by political and financial interests.” –