FDA, IATF quizzed on Covid vaccines
A lawmaker has raised questions about the Inter-Agency Task Force for the Management of Emerging Infectious Diseases and its statements regarding the safety and efficacy of Covid-19 vaccines.
Santa Rosa City Rep. Dan Fernandez, chairperson of the House Committee on Public Order and Safety, said at a joint hearing that IATF Resolution 148-B, issued on 11 November 2021, appeared to contradict the Covid-19 Vaccination Program Act of 2021 (Republic Act 11525).
Fernandez specifically cited Sections 2 and 7 of RA 11525, which he argued suggested the vaccines were still “experimental” and under clinical trials when the IATF declared them “safe and effective.”
“Why was the vaccine said to be safe and effective? Shouldn’t it be that since it was still experimental, we should not issue an Emergency Use Authorization?” Fernandez asked.
He raised concerns that the IATF and the Food and Drugs Administration may not have thoroughly explored all options before procuring and administering large quantities of vaccines, potentially exposing individuals to significant risks.
FDA Director Joyce Cirunay, however, defended the agency’s actions, saying that the FDA had the authority to issue Emergency Use Authorizations for Covid-19 vaccines under Executive Order 121.
“The FDA issued a circular that allowed the issuance of EUAs for products that had undergone clinical trials, including those in the interim phase 3 stage, where the benefit outweighs the risk,” Cirunay explained.
She said the FDA regularly monitors vaccine-related issues through its Pharmacovigilance arm, which assesses and prevents adverse effects associated with medications and vaccines.
Fernandez acknowledged the immunity granted to the FDA and IATF but argued that their actions may constitute willful misconduct and gross negligence for not taking steps to halt the issuance of EUAs, allegedly in violation of Section 7 of RA 11525.
The joint hearing, conducted in collaboration with the House Committee on Human Rights, aims to investigate the cause of the Philippines’ reported “excess deaths” in 2021 and assess the overall effectiveness of the country’s pandemic response.