WHO delays decision on Sputnik V, Russia seeks move forward with approval in Europe

The World Health Organization (WHO) continues to review data on the empty Sputnik V against the coronavirus to determine whether it approves its emergency use, but said on Tuesday that the decision is not imminent. Meanwhile, Russia has announced that it will try go ahead with approval in Europe.

“As with the other candidate vaccines, the WHO continues to evaluate Sputnik V vaccines from different production sites and will post decisions about your ad for emergency use when all data is available and the review is completeWHO said in a statement quoted by the AP agency.

The statement puts the brakes on expectations raised by Russian Health Minister Mikhail Murashko, who reported on Saturday that only administrative details were missing for WHO approval.

The organism stopped the drug approval process at the end of September Russian after detecting a series of violations during an inspection of a production plant vaccine which increases the risk of cross-contamination.

Approval from the agency is a key step in ensuring Sputnik V vaccination certificates are recognized worldwide, a necessary condition for international travel.

Pending the WHO definition, the government of Russia has announced that modernize “quality control methods” vaccine, with the aim of bring them into line with the standards of the European Medicines Agency (EMA) and get your approval in Europe.

“The developers of Sputnik V are currently working on the change in their methodologies“, said the director of the Center of Medical Expertise of the Russian Ministry of Health, Valentina Kosenko.

Kosenko recalled that the Russian vaccine is currently under review at the EMA, but “some methods used in Russia to control the quality of drugs are no longer used in countries with stronger pharmaceutical development, especially in Europe”.

At that time, he clarified that new methods will prioritize in vitro technologies, more modern compared to those inherited from the Soviet pharmaceutical company, which used animals.

In particular, the use of fetal bovine serum detected in the development of the vaccine became an obstacle to its approval, because after the outbreak of mad cow disease in 1986, European and American regulators asked the developers to document that the drugs were obtained from reliable sources.

According to the representative of the Russian Ministry of Health, currently all the countries of the world researching more accurate drug quality control methods.

At the beginning of September, the EMA reported that the dialogue with the developers of Sputnik V and the Chinese preparation Sinovac is “constructive”, but more information on the safety, efficacy and quality of these vaccines is still needed, so it is “Difficult” to set a timeline for finalizing the review.

In this context, Russia indicated on Sunday that the dialogue for the “mutual recognition of vaccination certificates” against the coronavirus was opened with the United States, a key step to facilitate travel abroad for Argentines who have received Sputnik V.

“Health Minister Mikhail Murashko held talks in Geneva with the United States and others on the recognition of travel certificates: ‘This is the start of a constructive dialogue’,” posted the official profile of Sputnik V.

With information from the EFE