The Food and Drug Administration (FDA) on Tuesday, May 11, defended the Department of Health (DOH) on its plan to apply for an emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine made by China’s Sinopharm.
FDA Director-General Rolando Enrique Domingo believes that there is “no conflict of interest” on the move of the DOH.
“Hindi naman… kasi nasa batas iyon and it’s a worldwide practice. Yung ating Executive Order 121 natin is based on WHO (World Health Organization) guidelines kasi talagang posible din naman na ang gobyerno ay gustong bumili ng bakuna pero walang local manufacturer or representative dito (It’s not… because it’s in the law and it’s a worldwide practice. The Executive Order 121 is based on WHO (World Health Organization) guidelines as it is really possible that the government wants to buy a vaccine but there is no local manufacturer or representative here),” said Domingo in a press briefing.
“In those cases, the government itself can get an EUA. Hindi naman conflict iyon kasi ang mga EUA ay hindi naman sila product registration or marketing authorization, talagang for emergency use lamang (There is no conflict because the EUA is not a product registration or marketing authorization. It is really only for emergency use),” he said.
The DOH will also undergo the same process when applying for an EUA, said Domingo.
“Wala naman masyadong pagkakaiba kasi ang emergency use authorization talagang pwede naman dalawa ang mag-apply. So pwede yung industry, meaning yung manufacturer or yung importer, distributor—kung sino man yung local na representative dito. Pero pwede din yung program implementer or yung procurer like the National Task Force or the DOH (There is not much difference because the emergency use authorization can actually be applied by two entities. So it can be the industry, meaning the manufacturer or the importer, distributor — whoever the local representative is. But it can also be the program implementer or the procurer like the National Task Force or the DOH),” he said.
“So kapag nag-apply sila ng EUA ganoon din naman, papakita nila yung data available and of course yung mga requirements na hinihingi ng FDA, particularly yung mga clinical trials. Tapos i-evaluate din siya ng ating Vaccine Experts Panel at saka ng ating mga regulators dito sa FDA (So when they apply for an EUA, they also need to provide the necessary documents such as the (vaccine’s) data that is currently available, particularly the clinical trial data, and other requirements needed by the FDA. Then it will be evaluated by the Vaccine Experts Panel and FDA regulators),” he added.
Domingo said that he already provided the DOH the list of requirements for EUA application. “Kahapon pinadala ko na sa kanila yung listahan ng requirements so I supposed they’ll submit it very soon (Yesterday I sent them the list of requirements so I supposed they’ll submit it very soon),” he said.
The FDA chief said it will take at least three weeks for the health regulators to evaluate the vaccine’s data. The Sinopharm vaccine also has an advantage because it was given an emergency use listing approval by the World Health Organization (WHO).
“Yung WHO na (The WHO’s) emergency use listing —that’s equivalent to a stringent regulatory authority,” he said.
In a statement, the WHO “recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79 percent, all age groups combined.”