HPAAC to government: Subject Sinovac to PH’s health technology assessment

The Healthcare Professionals Alliance against COVID-19 (HPAAC) has asked the government to subject China’s Sinovac Biotech to country’s health technology assessment process amid the Food and Drug Administration’s pronouncement that the CoronaVac vaccines were not recommended for health workers. 

The HPAAC said with the limitation imposed by the FDA recommendation on Sinovac, "we are now placed in 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? 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,” it said in a statement. 

In a televised government press briefing on Monday, Feb.22, FDA Director General Eric Domingo said after a thorough and rigorous review of the currently available published and unpublished data by the country’s regulatory and medical experts, the FDA has granted emergency use authorisation (EUA) to Sinovac’s vaccine, known as SARS-CoV-2 vaccine Vero Cell Inactivated, or the CoronaVac. However, he said the efficacy rate of Sinovac vaccine for healthcare workers is at 50.4 percent.

The HPAAC noted that the EUA recommends CoronaVac for clinically healthy people aged 18-59 years old, but does not recommend its use among healthcare workers, especially for those with exposure to COVID-19 patients. 

The HPAAC cited that Republic Act No. 11223  or the Universal Health Care Act of 2019) "clearly institutionalized Health Technology Assessment (HTA) as a fair and transparent mechanism that is recommendatory to the DOH and PhilHealth for the development of investment and benefit packages.”

This investment package refers to all attendant costs of implementation of health programs such as the logistics and human resource costs of vaccination program roll-out, it said. 

The group said the implementing rules and regulations of the UHC Law provides that the HTA process 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”.

It cited the need for foreign donated technology during pandemics and emergencies to still undergo technical appraisal by HTA Council (HTAC) in order to determine their clinical and economic value.  

It explained that HTAC deliberations do "not solely focus on cost minimization issues for the State, but also include “ethical, legal, social and health system implications”; with improvement of overall health outcomes as end goals.  Thus, it can be deduced that the legal mandate of HTAC cannot be negated just because the technology (i.e. vaccines) are donated."

"Though we welcome this donation and eagerly await other forthcoming donations from the COVAX Facility and from other donor entities as well, we however would still ask our leaders to await the recommendations of the HTAC - the way we did with the two previous vaccines that were granted EUA by the FDA before making any hasty moves or decisions,” the HPAAC said. 

It expressed confidence that the HTAC could "formulate these recommendations with judicious haste.”

"We just need to ensure that they will not be unduly influenced by political and financial interests,” the HPAAC said, even as it asked the public to be on guard and continuously stay vigilant on the government’s implementation of its  vaccination program.