According to five people with knowledge of the EU’s evaluation of the drug, the Russian Sputnik V coronavirus vaccine developer has repeatedly failed to provide data that regulators believe is required by the drug approval process standards, which provides new insights into the country’s struggle for victory. . Foreign recognition of its products.
Reuters reported last month that the European Medicines Agency (EMA)’s review of the drug’s safety and effectiveness was postponed because it missed the June 10 deadline for the submission of vaccine clinical trial data. The agency and another person familiar with the matter. EMA is the European Union’s drug regulatory agency.
People close to the agency said the problem exceeded that deadline. The person familiar with the matter said that as of early June, EMA had received almost no manufacturing data, and the clinical data received by the agency was incomplete.
In addition, the evaluation of Sputnik V by the French delegation of scientists before the EMA review found that the vaccine developer was unable to prove that the so-called master cell bank (the initial building block of the vaccine) complied with specific EU regulations. According to four people who understood the delegation’s findings Said about the prevention of disease pollution.
EMA initiated a formal review of the Russian vaccine in March, and was expected to decide whether to approve the drug in the European Union in May or June.
People close to EMA said that the clinical information that was apparently missing during the EMA review included case report forms, which documented any adverse reactions that people experienced after receiving injections in the trial. The person added that it is standard practice for developers to submit such forms. The person familiar with the matter said that it is unclear how the vaccine scientists track the results of people taking placebos.
Regulators rate such data deficiencies on a scale from “severe” (most serious) to “major” to “minor”. The person said that nothing reached the critical threshold, “but there are a few’main'”, indicating that the problem can be remedied, but a lot of work is required. The person added that they expected to complete the review after the summer.
Several people who interacted with the Gamaleya Institute in Russia, which developed Sputnik V and oversaw clinical trials, blamed the lack of experience in dealing with overseas regulatory agencies for the repeated failure to provide some information. “They are not used to cooperating with regulatory agencies like EMA,” said a person close to the agency, referring to Gamaleya scientists.
Gamaleya is supervised by the Russian Ministry of Health. Neither Gamaleya nor the Ministry responded to questions in this report. The Kremlin declined to comment.
Sputnik V is marketed overseas by the Russian sovereign wealth fund, known as the Russian Direct Investment Fund (RDIF).
RDIF stated that the Reuters report contained “false and inaccurate statements” based on anonymous sources that tried to harm Sputnik V as part of a false propaganda campaign. RDIF stated that the vaccine may be attacked by “Western pharmaceutical lobby groups,” but did not provide evidence of such activities.
RDIF added that the vaccine has been registered in more than 60 countries/regions, and studies from Argentina, Mexico, and Hungary where the vaccine is already being used have shown that the vaccine is safe and effective. It said that “no serious adverse events have been reported.”
Regarding the survey results of the French delegation, RDIF stated that “Sputnik V cell bank fully complies with all EMA requirements.”
RDIF stated that it is working closely with EMA, and EMA inspectors have visited Sputnik V’s production facility. RDIF said: “Judging from the inspections that have been completed, we have not received any major criticisms, and the questions raised did not doubt the safety and effectiveness of the vaccine.”
A person familiar with Europe’s efforts to evaluate the drug said that they have no reason to suspect that artificial satellites are a safe and effective vaccine. A study published by international scientists in The Lancet in February found that the effectiveness of artificial satellites exceeds 90%.
Amsterdam-based EMA declined to comment on the details of the ongoing review. The agency stated that it applies the same standards to all applicants and that to approve the COVID-19 vaccine, EMA needs “detailed information about its safety, effectiveness, and quality.”
The delay may allow rival vaccine manufacturers to open up key markets. The developers of Sputnik V encountered some mistakes when dealing with some overseas drug regulatory agencies reviewing vaccines. They found lack of data, insufficient methodological documentation, and non-compliance with what they believed to be standard protocols.
After the technicians emphasized the “inherent risk”, the Brazilian regulatory agency initially refused to import Sputnik V, citing the lack of data to ensure its safety, quality and effectiveness. Slovakia’s drug agency said it had insufficient data from Moscow until the government finally granted limited approval for the vaccine. Although some people familiar with the process said that some experts from the Hungarian drug regulatory agency expressed concern about the lack of documentation, Hungary urgently approved the jab.
Brazilian regulator Anvisa granted conditional approval to the import of Sputnik V last month. Anvisa told Reuters that these conditions “are designed to overcome the information gap in the process and ensure the minimum conditions for vaccine safety and quality.” It added that Sputnik V has not been distributed to the Brazilian people.
When the Hungarian regulatory agency approved Sputnik V in January, it publicly acknowledged that there may be conflicting opinions during the authorization process and has received reassuring answers to the vaccine question. The Slovak government said this month that it had sold most of its satellite V back to Russia due to low interest rates.
