Polina Nikolskaya and Emilio Parodi

(Reuters) – It is not likely that the EU’s drug regulator will approve Russia’s Sputnik V coronavirus vaccination until the end of the first quarter 2022, according to a source who is familiar with the matter.

The source indicated that an EMA decision before the end of this year was now impossible.

According to him, if all the necessary data has been received by November’s end, the regulators could make a decision in the first quarter next year. Due to the sensitive nature of the issue, he declined to identify himself.

The EMA launched its official review of Russian vaccines in March. It was previously expected that the EMA would decide whether or not to allow the use of this vaccine within the bloc in May or June.

The Lancet has published the results from Phase III trials in February. These showed it to be almost 92% effective. Russia later claimed that Sputnik V was around 83% efficient against the Delta-type variant.

This vaccine has been approved to be used in over 70 countries and is currently widely available in Russia. Sources said that there were no reasons to doubt the effectiveness and safety of the vaccine.

Gamaleya Institute is a Russian health ministry that developed and managed the vaccine. The Russian Direct Investment Fund, a Russian sovereign wealth fund (RDIF), sells Sputnik V abroad.

RDIF did not comment. The health ministry also declined to comment.

In an email, EMA indicated that the vaccine is still being reviewed and under continuous review to ensure sufficient evidence for a formal marketing authorisation.

The agency stated, “EMA will have a better position than others to comment on the timelines for authorisation of Sputnik V when a marketing application has been submitted.”

The company stated on September 9 that they were still waiting for more data about Sputnik V in order to move forward with their review.

“EMA demanded a fuller dossier about production and details on how the vaccine was made. Source said that once the dossier is complete, they’ll be able identify where to request inspections.

The source stated that these details included both production and bottling.

Moscow’s slow approval rate is just one of the many problems it faces. Moscow hopes an international regulator will help it compete against vaccines from the U.S. Pfizer (NYSE: Moderna These companies have dominated the international market.

Reuters was told by manufacturers that the production of the second vaccine dose has not been easy, which hinders efforts to increase domestic output.

Russians who wish to visit the area would find it very convenient to have EU approval. The EU only recognizes vaccines approved by the EMA and the World Health Organization.

There were also issues with the WHO’s assessment of including the shot into its program for poorer countries.

Reuters reported that Sputnik V’s developers had failed repeatedly to submit data required by regulators for the approval process.

Slow Progress

A source who was involved in manufacturing told Reuters that the review took too long because Gamaleya had never dealt with an international regulator.

First source claimed that the EU developers had made changes to the production site of vaccine doses a number of times. Another reason for delays was also stated by the first source.

He said, “They continue to change the location of vaccine production sites that were supposedly destined Europe.”

Every facility in the production chain is reviewed by the EMA. Alexey Repik (chairman of Russian drugmaker R-Pharm) stated that its factories would be considered for the EMA application, though he declined to provide any further information.

According to a third source, the Russian shot was produced by an inspector from EMA. The inspections visited two R-Pharm sites in western Yaroslavl. He said that the EMA made no criticisms of these locations.

The EU would be able to purchase shots from a third R-Pharm location in Moscow. But, after the EMA reviewed the submission, he stated that it had been included in the regulatory submission.

He said that inspection would be done before the end of the year.

Moscow, the EU ambassador said that Russia has repeatedly deferred inspections by the EMA required for certification of the vaccine.

According to the first person who knew about this matter, there were no doubts that Sputnik was effective and safe.

He stated that “but with these incomplete data, EMA doesn’t really have to make a decision”

The ball is now in their hands. It is up to them to choose what they wish to do.