The World Health Organization said on Wednesday it had uncovered problems at the Sputnik V COVID-19 vaccine production site, which Moscow insisted had been resolved.
WHO approval has been sought for the Sputnik V jab, made by Russia’s Gamalaya Research Institute, which is already being used in 40 countries.
The United Nations health agency inspected four Sputnik V construction sites.
On Wednesday, it released a summary report of its preliminary findings, detailing six issues it found during a visit to the Farmstandard Ufa Vitamin Plant in Ufa, southern Russia, from May 31 to June 4.
Inspectors were concerned with data integrity and test results from monitoring during manufacturing and quality control, and with monitoring and controlling aseptic operation and filling.
The inspection identified issues with the identification and identification of vaccine batches.
There were also concerns over filling lines, sterility assurance, sterile filtration validation and the risks of cross-contamination.
Kremlin spokesman Dmitry Peskov said that “there were some shortcomings identified by the inspection group, and from what we know, they were taken into account and everything that needed to be changed was changed.”
“Of course the controls required by the control bodies are in place. It is clear that this is the strictest control possible”, he said.
The WHO said the plant had been informed of its findings.
“Communications have been initiated with the relevant manufacturer, applicant and the relevant national regulatory authority to examine the preliminary findings outlined in this report and address them as soon as possible,” the organization told AFP.
WHO approval process
The WHO Emergency Use List is the green light that gives countries, funders, procurement agencies and communities assurance that a vaccine meets international standards.
The EUL paves the way for countries to approve and import a vaccine for rapid distribution, especially in states that do not have their own international level regulators.
It also opens the door for entry into the Covax global vaccine delivery facility, which aims to provide equitable access to doses in poor countries.
The WHO has so far granted EUL status to vaccines made by AstraZeneca, Pfizer-BioNtech, Moderna, Johnson & Johnson, Sinopharm and Sinovac.
According to AFP calculations, the Sputnik V vaccine is already in use in 40 countries.
In addition to Russia, those countries include Argentina, India, Iran, Kenya, Mexico, Pakistan, the Philippines, and the United Arab Emirates.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)