Bayanihan 2 waives off phase 4 trial for coronavirus vaccine: senator


Posted at Aug 21 2020 10:40 AM | Updated as of Aug 21 2020 09:00 PM

Health workers administer flu and pneumonia vaccines to 75-year-old Lolita Espiritu as part of their community vaccination drive in Barangay Pembo, Makati City on Aug. 12, 2020. George Calvelo, ABS-CBN News/File

MANILA — A proposed law will waive a required stage in the trial of coronavirus vaccines to speed up the drug’s procurement once available, a senator said Thursday. 

The universal health care law requires vaccines to undergo Phase 4 trial, said Senate Minority Leader Franklin Drilon. This stage concerns additional studies after a vaccine is approved and licensed, according to the US Centers for Disease Control and Prevention. 

Malacañang and the health department had asked lawmakers to waive the Phase 4 requirement through the Bayanihan to Recover as One bill, which would also let President Rodrigo Duterte realign P140 billion for the coronavirus crisis, said Drilon. 

“Iyong Phase 4 ay ini-waive para sa procurement,” he told ABS-CBN’s TeleRadyo. 

“Ibig sabihin, kung sa certification ng WHO (World Health Organization) ay ang isang vaccine ay puwede nang gamitin kahit hindi po dumaan sa Phase 4, payag na po, may authority na bilhin."

(The Phase 4 was waived for procurement. This means that if the WHO certification says that a vaccine can be used, it doesn’t need to undergo Phase 4 anymore and there is authority to buy it.) 

The local Food and Drug Administration still needs to certify that the vaccine is safe before it can be distributed to Filipinos, Drilon said. 

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Moscow recently said it was pushing forward with testing on more than 40,000 people of its candidate vaccine, known as Sputnik V, which has already been hailed by Russian officials as a success even as experts questioned the rigor of the testing regime.

Several drugs are approaching the mass-testing phase, and countries around the world have been pre-ordering many millions of doses.

While a vaccine remains elusive, governments are left trying to control the spread through social-distancing measures, quarantines, travel bans and restrictions on businesses. — With a report from Agence France-Presse