EU drug regulators will begin an investigation next week to see if clinical trials of the Russian Sputnik V Covid-19 vaccine violate ethical and scientific standards.
The European Medicines Agency’s investigation into whether the Sputnik V trial meets “good clinical practice” criteria raises concerns that people familiar with the regulatory approval process are not ethically conducted by the Financial Times. Will be done when you declare. GCP is an internationally agreed standard aimed at ensuring that clinical trials are properly designed and conducted.
Russia said military personnel and state employees were involved in the trial of a jab developed by a state-owned research institute and funded by the Russian Foreign Direct Investment Fund, Kremlin’s sovereign wealth fund. Reuters reported that some of the participants said they had been pressured by their bosses to do so.
Kirill Dmitriev, head of RDIF, denied the use of coercion and told FT: [on participants] Sputnik V complies with all clinical practices. He said the EMA test is scheduled to begin next week.
Russia has touted Sputnik V as a possible solution to the European vaccine problem, but EU Commissioner Thierry Breton, who heads the block vaccine program, said last month that Europe “doesn’t need Sputnik V at all.”This triggered a claim from Moscow Brussels had a prejudice For Russian-made jabs.
The EMA is reviewing Sputnik V, but has not yet decided whether it can be used in the EU. Approval relies on clinical trials that meet GCP standards.
“Compliance with this standard ensures that the rights, safety and well-being of study participants are protected and that clinical trial data are reliable,” said EMA, who could order testing when concerns were identified. I added that I can do it. Regulators declined to comment on planned or ongoing inspections, including Russia.
Dmitriev noted that regulators in 59 countries that have already approved Sputnik V are “satisfied with the GCP compliance after very rigorous processing of the data.”
The sovereign wealth fund boss continues: “The EMA’s concerns about GCP are not recognized. Such a leak of concerns is a concrete example of those who are trying to undermine the unbiased and non-discriminatory EMA approval process.”
In addition, the individual EMA inspection of Russia’s Sputnik V production facility scheduled for next month was delayed by a few days as it had to accommodate inspector visits from the country that ordered the jab, Dmitriev said. .. “We prioritize those who have promised to buy the vaccine … unlike the European Commission,” he said.
EU has Faced with growing criticism About the stuttering vaccine program. The block inoculates people who are significantly smaller than the United Kingdom or the United States as a percentage of the population, and authorities have pointed out a lack of vaccines as one cause.
EU member states Hungary and Slovakia used emergency regulations to purchase the Sputnik V vaccine, but the Slovak Prime Minister I was forced to stop Last month after his decision to buy a Russian jab caused a backlash from his own minister.
Vaccine shortages are coming as much as much of the EU is working on Third wave of virus infectionThere are cases of increasing hospitalizations and deaths in many European countries.
EU regulators investigating ethical standards for Sputnik vaccine trials
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