‘Autonomous’ FDA must screen COVID-19 vaccines free from DOH meddling

Buhay Rep. Lito Atienza is pushing for the passage of his bill that will enable “a truly autonomous” Food and Drug Administration (FDA) to screen over 30 potential COVID-19 vaccines, including one from the maker of Dengvaxia.

“We want a new and totally independent FDA to analyze every coronavirus vaccine tendered, not just to avoid a repeat of the Dengvaxia mess, but to ensure that Filipinos get the best possible immunization in terms of efficacy and safety without any shortcuts,” Atienza said.

“One of the lessons we learned from the Dengvaxia affair is that we have to insulate the FDA from unwanted external pressures, including those that might come from future health officials who are also politicians,” Atienza said.

Under House Bill 1106, Atienza wants the FDA to be completely detached from the Department of Health (DOH), whose officials in the past had been accused of meddling in favor of the expedited regulatory approval of Dengvaxia.

Since its establishment in 1963, the FDA has always been attached to, and under the supervision of the DOH.

Atienza, however, stressed the need for Congress “to safeguard the FDA’s professional integrity if we want the agency to effectively perform its job of protecting public health against unsafe biological products and pharmaceutical agents.”

“The FDA should be absolutely free from somebody else’s authority,” Atienza, former three-term mayor of Manila, said.

Around 30 experimental coronavirus vaccines are already undergoing the last phase of human trials around the world, including one being developed by the maker of Dengvaxia and with a reported higher efficacy of 70 percent.

FDA Director General Eric Domingo earlier said the agency will likely start analyzing applications for the first COVID-19 vaccines by the second quarter of 2021.

Widespread immunization against the coronavirus is not expected until mid-2021, despite the anticipation of progress in producing available vaccines, according to the World Health Organization.