Position Statement on the FDA Recommendations and EUA for CoronaVac (Sinovac Life Sciences)
On February 21, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the CoronaVac (Sinovac Life Sciences). 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.
Because of this 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.
Republic Act 11223 (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. 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” (Section 34.2.c, IRR UHC Law).
In view thereof, foreign donated technology during pandemics and emergencies must still undergo technical appraisal by HTA Council (HTAC) in order to determine their clinical and economic value. HTAC deliberations does 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. 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.
We end this statement once again with a plea for continued vigilance, dahil ito ay BAKUNA NATIN.