DOH CONDUCTS TOWNHALL WITH EXPERT GROUPS THAT ENSURE SAFETY AND EFFICACY OF COVID-19 VACCINES

Press Release | 27 May 2021

The Department of Health (DOH) on Wednesday conducted a town hall to introduce the DOH All Experts Groups on COVID-19 Vaccines who scrutinize the safety and efficacy of COVID-19 vaccines from selection, procurement, and deployment. Currently, these expert groups guide the overall implementation of the COVID-19 vaccination program of the country.

The Vaccine Cluster and DOH issue vaccination policies, guidelines, and protocols following the scientific assessment and recommendations of these independent bodies after rigorous review of available evidence.

Department of Science and Technology (DOST) Vaccine Expert Panel (VEP)

The first stage of vaccine evaluation lies within the mandate of the VEP as defined by the DOST-Philippine Council for Health Research and Development. The VEP identifies and evaluates all possible vaccine candidates which involves analyzing the track record of the companies developing or manufacturing the vaccines, the platform used, clinical trial results and potential efficacy, dosing schedule, and all other data from various phases of vaccine development, in accordance with the criteria set by the World Health Organization, with additional considerations suited for local needs.

The VEP endorses the results of its technical assessment to the Vaccine Cluster’s Task Group on Vaccine Evaluation and Selection which will advise the negotiations of the Vaccine Czar and Task Group on Procurement and Finance. Additionally, they assist the FDA in the review of vaccines that are applied for  Emergency Use Authorization (EUA). The VEP also conducts the technical evaluation of COVID-19 vaccine clinical trial applications submitted to the FDA.

Health Technology Assessment Council (HTAC)

The HTAC is an independent body created under the Universal Health Care (UHC) Act that guides coverage decisions of DOH and Philhealth. When it comes to the COVID-19 vaccination program, HTAC ensures equitable access to vaccines and ensures its efficacy and safety for specific groups. All vaccines that will be procured by the Philippine Government must receive a positive recommendation from HTAC.

When making recommendations, HTAC considers the vaccine’s ability to significantly reduce the magnitude and severity of COVID-19 and its safety, affordability, and feasibility for use in the national vaccination program. Through the HTAC Evaluation Framework, the Council looks into how the vaccine aligns with key stakeholders and the general public’s desired characteristics of a COVID-19 vaccine. It also takes into account if the specific vaccine reduces or adds to the existing social inequities in the health system.

DOH Technical Advisory Group (TAG)

The TAG is composed of independent infectious disease experts who provide evidence-based independent technical assessment and advice to the DOH on the over-all COVID-19 response and management. These response strategies include implementation of the Prevent, Detect, Isolate/Quarantine, Treat, and Reintegrate (PDITR).

National Immunization Technical Advisory Group (NITAG)

The NITAG is an independent body composed of public health experts that inform policies of the vaccination program based on evidence, ensuring transparency, credibility, and technical soundness to the decision-making process and contributes to building public confidence COVID-19 vaccination program. NITAG determines and recommends priority groups based on the recommendations of the World Health Organization Strategic Advisory Group of Experts and sets indicators in determining priority geographical areas for vaccination.

National Adverse Event Following Immunization Committee (NAEFIC)

The NAEFIC is composed of medical and vaccine experts that review, analyze, and conduct causality assessment of any Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) upon deployment of vaccines. NAEFIC suggests the basis for the action of the FDA and concerned DOH bureaus/offices.

The Philippine FDA gives the final approval for granting emergency use authorization for vaccines. When an application is submitted to the FDA, the FDA’s Center for Drug Regulation and Research reviews the completeness and veracity of the submitted documents and provides technical assessment on the vaccines and the manufacturing process.

In the end, only vaccines that meet the following criteria will be given an EUA:
● Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the vaccine may be effective to prevent COVID-19;
● The known and potential benefits of the vaccine outweigh the known and potential risks of the drug or vaccine, if any; and
● There are no adequate, approved, and available alternatives to the vaccine for preventing COVID-19.

The DOH assured the public that vaccines undergo a stringent regulatory process -- from selection, procurement, to administration, vaccines undergo the evaluation and scrutiny of different experts to ensure its safety and efficacy. Get to know the DOH All Experts Group more at http://bit.ly/DOHRosterOfExperts.