FDA to get more information on COVID vaccine developed by Russia

Published August 12, 2020, 11:44 AM

by Noreen Jazul

The Food and Drug Administration said Wednesday it would like to “get more information” on the COVID-19 vaccine being developed by Russia.

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. (Photo by Handout / Russian Direct Investment Fund / AFP / MANILA BULLETIN)

In an interview with CNN Philippines, FDA Director-General Eric Domingo raised concern about the Russian vaccine because it has yet to enter Phase 3 or the last phase of clinical trials.

Domingo said he would also like to know what “approval process” the vaccine went through.

“Usually, we approve vaccines after the completion of the third phase of the clinical trials,” Domingo said.

“We really want to know how accelerated the approval was and what the basis was for that,” he added.

When asked if a separate trial on the Russian vaccine will be conducted in the country, Domingo said such will depend on the developer or clinical trial sponsors.

“Unless the clinical trials are sponsored, for example, by the Department of Health, [then] that can also be done,” he said.

Domingo said the FDA approves vaccines only after the completion of tests on a large number of patients and once the “safety and efficacy” of the vaccines are assured.

The FDA director said a vaccine will “probably be available” by the end of the year or early next year, noting that there are already about six vaccines in the last phase of trials.

The Russian Health Ministry on Tuesday said it has developed the world’s first COVID-19 vaccine and called it “Sputnik V.”

 
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