With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
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With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
Kirill Dmitriev, chief executive officer of Russian Direct Investment Fund, which has spearheaded Sputnik V, said RDIF has been coordinating with the governments of Italy, Spain, France and Germany to launch production of Sputnik V. This will bolster supplies of the vaccine to Europe once the preventative medication receives authorization from the European Medicines Agency.
“We are now actively working with EMA as part of the rolling review procedure. In addition, RDIF and partners are ready to start supplies to those EU countries that independently authorize Sputnik V,” Dmitriev said in an email to BioSpace.
In a separate email, Dmitriev went on to note that Russia ranks among the top five countries in vaccinations against COVID-19. He said 3.5 million people received both doses of Sputnik V in Russia.
“No other European country has yet fully vaccinated 3 million people. Great Britain, which is often mentioned as an example of quick vaccination, has given both vaccine doses to less than half number of people than in Russia,” Dmitriev said. He added that Russia’s estimates are more conservative than other countries, relying on the administration of two doses of the vaccine instead of adding the first dose in as part of its metric.
While politics will likely play a part in whether or not Sputnik V gains a toehold in Europe alongside western-designed vaccines, Russia has been busy striking deals with many Eastern European countries, such as Hungary and the Czech Republic, as well as governments in the Middle East and South America. In February, Sputnik V stood up to peer review in The Lancet. The prestigious journal published an interim analysis of Phase III data for the Russian-made vaccine that showed the preventative medicine generated an efficacy of 91.6% against the original strain of the virus. Only two other vaccines currently authorized against COVID-19 have shown higher efficacy. The mRNA vaccines developed by Moderna and Pfizer and BioNTech have demonstrated a 94% and 95% efficacy, respectively.
As the world continues to clamor for faster vaccination against COVID-19, Russia is seeing opportunity in places where governments are balking at deploying the vaccine developed by AstraZeneca and Oxford University. Over the weekend, Ireland and The Netherlands became the latest countries to suspend the use of the vaccine as part of precautionary measures due to blood clotting concerns. As BioSpace previously reported, there have been 30 cases of thromboembolic events among five million people who had received the AstraZeneca shot in Europe, according to the European Medicines Agency. The EMA was quick to point out the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. Because of that, the EMA did not suggest pausing dosing with the AstraZeneca vaccine. However, multiple governments across Europe have done just that.
In response to the concerns, AstraZeneca announced over the weekend it had conducted a safety review of the nearly 17 million people who have received its vaccine, which includes shots administered beyond the borders of Europe. The company said the review has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country. Across Europe and the United Kingdom, AstraZeneca said there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, as of March 8. AstraZeneca said these events are lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The company also pointed to its clinical trial data and said there was no evidence of increased bleeding in the more than 60,000 trial participants.
Also this morning, Switzerland’s Molecular Partners and Novartis announced ensovibep is expected to be included in a global Phase III clinical trial that will be part of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial, ACTIV-3, is designed to evaluate the safety and efficacy of various therapies for the treatment of adults hospitalized with a COVID-19 diagnosis. Ensovibep is a DARPin therapeutic candidate designed to bind to the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells, and may provide added protection against variant strains.
Ensovibep is currently being evaluated in a Phase I single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered ensovibep. Initial data from this study indicate that ensovibep is well tolerated with a half-life in the range of two to three weeks.
