WHO found problems in the plant where the Sputnik V vaccine is made

The World Health Organization said it discovered problems at a Sputnik V COVID-19 vaccine production facility that Moscow said had been resolved. WHO has requested approval of the Sputnik V vaccine, created by the Russian research institute Gamaleya, which is already in use in 40 countries.

The United Nations health agency inspected four manufacturing centers of Sputnik V.

On Wednesday, he released a summary report of his preliminary findings, detailing six problems detected during your visit from May 31 to June 4 with vitamin plant Pharmaceutical standard Ufa, in southern Russia.

The inspectors worried data integrity and follow-up test results during manufacturing and quality control, as well as for the monitoring and control of the aseptic operation and filling.

The inspection detected problems of traceability and identification of batches of vaccines.

Problems were also detected in the filling lines, guarantee of sterility, validation of sterile filtration and risks of cross-contamination.

“Communications have been initiated with the relevant manufacturer, the applicant and the respective national regulatory authority, so that the preliminary results presented in this report are investigated and addressed as soon as possible.“WHO told the agency AFP.

Kremlin spokesperson, Dmitry Peskov, said there was “some deficiencies identified by the inspection team and, to our knowledge, these were taken into account and changed everything that needed to be changed”.

“Of course, the necessary controls by the control bodies are in place. It is obvious that this is the strictest control possible“He added.

WHO Emergency Use List (EUL) approval is the green light for countries, donors, procurement agencies and communities assurance that a vaccine meets international standards.

WHO said it had so far carried out nine inspections of Sputnik V.

Among them are five clinical trial centers visited jointly with the regulatory body of the European Medicines Agency and four manufacturing sites, two of which were joint visits with the EMA.

Of these last four inspections, WHO “Non-compliance observed with good manufacturing practices in a manufacturing plant”, He said. “The results of the other Sputnik V vaccine manufacturing sites that WHO has inspected are still being evaluated, but have not raised similar concerns.”

The organization said it would continue to evaluate Sputnik V vaccines from various manufacturing centers and would publish its decision on the status of the EUL once all the data were available and the review was completed.

EUL paves the way for countries to quickly approve and import a vaccine for distribution, especially states that do not have their own world class regulator.

It also opens the door to vaccines to enter the global vaccine distribution service of Covax, whose objective is to provide a equitable access to doses in the poorest countries.

So far, WHO has granted UEL status to vaccines created by AstraZeneca, Pfizer-BioNTech, Moderna, Johnson & Johnson, Sinopharm and Sinovac. The WHO vaccine summary shows that among other vaccines that have not yet received EUL status, Sputnik V is the most advanced in the process.

Sputnik V is already in use in 40 countries, according to an AFP count. Besides Russia, these countries include Argentina, India, Iran, Kenya, Mexico, Pakistan, the Philippines and the United Arab Emirates.

(By Robin Millard / AFP)

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