On Thursday, a statement on the European Medicines Agency (EMA) website confirmed that the review had been ordered. According to officials, the “decision to start the rolling review is based on results from laboratory studies and clinical studies in adults.” The move comes after two member states unilaterally approved the jab without waiting for the regulator.
These studies, they add, “indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.” The EMA will now continue to evaluate data as it becomes available to determine whether “the benefits outweigh the risks.”
The rolling review, the regulator says, is being used “to speed up the assessment of a promising medicine during a public health emergency.” It allows consideration of the jab before all documentation is in place.
Kirill Dmitriev, the CEO of the Russian Direct Investment Fund (RDIF), which financed the development of the formula, said that “We have provided EMA with all the necessary data on the vaccine, which has already been approved by more than 40 countries around the world.”
“Sputnik V has the potential to make a critical contribution to saving millions of lives across Europe,” he said. “Vaccine partnerships must be above politics, and working with the EMA is a great example confirming that only by joining forces can we defeat the pandemic,” he added.
A number of EU member states have already approved the Russian-made jab on an individual basis, without waiting for the central regulator to conduct its review. Sputnik V is already registered in both Hungary and Slovakia.
Hungary’s prime minister, Viktor Orban, told journalists that politics shouldn’t be a factor in making potentially life-saving formulas available. “There is no Eastern or Western vaccine – there are only the good ones and bad ones,” he said. “The Hungarian health authorities have run their tests and guarantee the effectiveness of the vaccine.”
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