FDA: Sputnik V finally up for review after completing emergency use application

FDA: Sputnik V finally up for review after completing emergency use application
This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
AFP / Russian Direct Investment Fund, Handout

MANILA, Philippines — Russia's Gamaleya Research Institute has submitted all the documents needed to complete its application for the emergency use of its COVID-19 jab Sputnik V in the Philippines, allowing local regulators to begin their evaluation.

This was confirmed by Dr. Oscar Gutierrez Jr., the Food and Drug Administration's deputy director general for field operations, in an interview on ANC's “Dateline Philippines." Gamaleya applied as early as January 6 for emergency use authorization (EUA).

"They completed their requirements only yesterday so it is up for evaluation and I will be part of that team," Gutierrez said, adding that an initial evaluation showed that the Russian state-run institute already met the requirement for Good Manufacturing Practice (GMP) certification.

FDA director general Eric Domingo on Thursday said an FDA team would be flying to Russia next week to inspect the manufacturing site to see if it conforms to GMP standards. But Gutierrez said the team will discuss on Monday if an inspection is still needed given the certification presented by Gamaleya, adding that local regulators did not inspect the facilities of other manufacturers whose vaccines have been granted an EUA.

A peer-reviewed study published in The Lancet medical journal found Sputnik V to be 91.6% effective against COVID-19. 

The Philippines plans to buy 20 million vaccines from Gamaleya. Philippine Ambassador to Russia Carlos Sorreta last month said discussions for the acquisition of Sputnik V were in a "very advanced stage."

Foreign Affairs Secretary Teodoro Locsin Jr. also said in February that the private sector will bring in more jabs from Gamaleya but did not offer any further details.

Why is this important?

If Sputnik V is green-lit for emergency use, it would be the vaccine with the highest efficacy rolled out in the Philippines to date if deliveries from Gamaleya arrive before jabs from Pfizer or Moderna.

So far, only donated Sinovac jabs from China and AstraZeneca vaccines from the COVAX facility have been rolled out in the country. The government is still scrambling to finalize deals with manufacturers.

The need for the life-saving jabs has only become more apparent in recent days, with the Philippines on Saturday logging over 5,000 new cases of COVID-19, the highest daily rise since August last year.

Sen. Panfilo Lacson on Friday flagged the country's slow rate of vaccination, saying it might take 11 years and eight months to reach herd immunity if nothing changes. If the supply of vaccines is interrupted, he warned, it might take even longer.

— Bella Perez-Rubio



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