Gamaleya withdraws clinical trial application, applies for EUA instead

Russia's Gamaleya Research Institute has withdrawn its application to conduct Phase III clinical trials in the Philippines, an official from the Department of Science and Technology said Friday.

Under the supposed third and final phase of clinical trials, the efficacy and safety of the vaccine will be tested on 300 to 3,000 volunteers, according to the Food and Drug Administration (FDA).

DOST Undersecretary Rowena Guevara said Gamaleya, the manufacturer of Sputnik V vaccine against COVID-19, withdrew its application for trials because it will instead be applying for emergency use authorization from the FDA.

"Yung pong Gamaleya, sabi po ay today or bukas po magsa-submit [ng EUA application] sa FDA," she said in an online briefing.

Applies for EUA

Interviewed on Quarantined with Howie Severino later Friday, FDA director general Eric Domingo said Gamelaya has just applied for EUA.

"Well, ang pinakahuli ngayong araw na ito, nag-apply na rin 'yung Gamaleya, 'yung Sputnik V na vaccine," Domingo said.

"Ito ngayon ay nire-review siya namin ngayon kung kumpleto 'yung kanilang requirements at kung mayroong kulang and usually ang gagawin natin susulatan natin sila para sabihin kung ano ang kailangan pa nilang ipadala para mag-proceed na tayo sa evaluation."

Gamaleya has so far secured an EUA in three countries — Russia, Argentina, and Belarus.

Pfizer was the first to submit its EUA application to the Philippines on December 23, 2020. It has existing EUAs in the UK, USA, Kuwait, Mexico, Singapore, and Canada.

On the other hand, AstraZeneca submitted its application last January 6. It already has an EUA in the UK, Mexico, Argentina, and India.

Earlier this week, Manila’s Ambassador to Beijing Jose Santiago “Chito” Sta. Romana said two of China’s COVID-19 vaccine makers — Sinopharm and Sinovac — will also seek EUA in the Philippines.

Securing an EUA would mean a reduction in the processing time for the approval of the vaccines for local use from six months to 21 days. —KBK, GMA News