Due to storage needs, not all LGUs can get Sputnik V COVID-19 vaccine: FDA


Posted at Apr 29 2021 11:16 AM | Updated as of Apr 29 2021 11:24 AM

Due to storage needs, not all LGUs can get Sputnik V COVID-19 vaccine: FDA 1
A medical specialist holds a vial of Sputnik V vaccine against the coronavirus in a department store in Moscow, Russia, Jan.18, 2021. Shamil Zhumatov, Reuters/File

MANILA - Russia's Sputnik V COVID-19 vaccine will not be distributed to all local government units due to its stringent storage and handling requirements, the country's drug regulator said Thursday.

Food and Drug Administration Director General Eric Domingo said the vaccine, which was 91.6 percent effective against the coronavirus, must be kept in specialized freezers at extremely low temperature.

"That really is an issue. That means this Sputnik vaccine is probably going to go to the big city centers or where they have hospitals and they have storage facilities that will be able to hold the minus 18 degrees centigrade vaccines," he told ANC. 

"It's not going to be as widely distributed as Sinovac and AstraZeneca. They will have to be more choosy where to set it."

Once the Russian made vaccines arrives in the country, Domingo said health authorities would conduct another simulation.

"I think it's because they're trying to get used to the stringent co-chain management," he said. "Unlike the vaccines that have come before that can be kept in regular pharmaceutical freezers and refrigerators, this one needs special care because of the minus 18 degree-requirement," he said.

Although the World Health Organization and European Medicines Agency have yet to start their next round of review of the Sputnik V vaccine, Domingo assured the public of its safety and efficacy.

"If you look at our timeline, it took us the longest probably to check the Russian vaccine because we really required and asked for all the documents regarding safety and efficacy, and of course, the quality of the product," he said.

"But we were satisfied in the end after so many exchanges of emails and communication. They were able to submit all of the health [documents] required."

"It is published in a very well-known peer-reviewed journal, all of their clinical trial data. That was enough for our experts to say that it is a good vaccine to use," he added.

The FDA granted emergency use authorization to Russia's vaccine in March.

Domingo said Sputnik V is a viral vector vaccine. It uses adenoviruses to carry the genetic information needed to generate immunity against COVID-19 into the body but is designed to strip those vectors of the ability to replicate.

The vaccine has also been developed in a powder form that can be stored at fridge temperatures but production had not yet begun, he added.


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