Solon justifies waiving Phase 4 trial for COVID-19 vaccine
Zamboanga Sibugay 1st district Rep. Wilter "Sharky" Wee Palma IIÂ has justified the proposal to waive the Phase 4 trial requirement for COVID-19 vaccines to be procured by the Philippine government.
In an interview Thursday night, Palma said the proposal, which was retained in the Bicameral Conference Committee report on the "Bayanihan to Recover as One" bill, simply intends to help the Philippines get ahead in the long queue of countries that would want to buy the vaccine once it is out in the market.
"Ang ginawa na lang namin (What we said in the bill) is, we will waive the Phase 4 requirement insofar as procurement (is concerned). Let me repeat, procurement only," said the solon, who was part of the House of Representatives contingent in the just-concluded bicameral meetings with senators on the so-called "Bayanihan 2" stimulus package.
"Otherwise, baka maunahan tayo sa pagbili (others will purchase ahead of us). Once it is open in the market, dapat nakapila na tayo (we should be in queue). We should have signified our intent to buy already," he said.
"Definitely, we anticipate that there would be a shortage of the vaccine because worldwide pandemic to eh (this is a worldwide pandemic)," reasoned Palma, a member of the House Committee on Rules.
Millions, or even billions worth of dosages of the COVID-19 vaccine are expected to be ordered from all points of the globe. In other words, there's a real possibility that some nations will get wait-listed for their supply of the vaccine.
Phase 4 of the vaccine development process refers to the completion of the post-marketing surveillance of the medicine. "Medyo magtatagal talaga if we will follow Phase 4 (Following Phase 4 will really take time)," Palma said.
Citing the example of vaccine frontrunner Russia, Palma said its antigen candidate needs to meet three requirements in order to satisfy the procurement provision for drugs and vaccines in Bayanihan 2.
He said the Russia vaccine must 1) get approved by its Food and Drug Administration (FDA)-equivalent agency, 2) get approved by the World Health Organization (WHO), and, 3) gain international recognition. "Yun lang ang requirement natin (Those are our only requirement)."
After that, the Philippines may begin to procure (purchase) or accept donations of the vaccine.
"Afterwards, we will encourage also the pharmaceutical companies that we have to conduct their own personal research and development, and even standards for the distribution in cooperation with our FDA and HTAC (Health Technology Assessment Center)," the Mindanaoan solon said.
The bicameral meetings on the P165-billion Bayanihan 2 took four days to complete. The Senate ratified the resulting report from the meetings on Thursday night.
Meanwhile, House Majority Leader Martin Romualdez said the House would do the same next week. This will pave the way for the bill to be signed into law by President Duterte.