Invasion of Ukraine Could Curb Availability of Russia’s Sputnik V Vaccine
Russia has been seeking approval of its Sputnik V vaccine from the World Health Organization for some time but that approval may be in jeopardy due to that country’s invasion of Ukraine.
While the vaccine has shown efficacy against multiple strains of COVID-19, Sputnik V, which became the world’s first authorized vaccine against the SARS-CoV-2 virus, has been unsuccessful in penetrating health spheres of western countries, including the European Union and the United States.
Concerns about data as well as manufacturing issues have delayed the Russian Direct Investment Fund’s efforts in gaining approval from the WHO and the European Medicines Agency.
With U.S.-led economic sanctions tightening around Russia and commerce in that country becoming strained due to international pressure, the RDIF issued a statement that it is not involved in political activities and claimed that sanctions that inhibit the expanded use of Sputnik V have demonstrated that the government of the United States “has picked the course to destroy constructive dialogue between countries.” RDIF said it believes that the announced measures to restrict its operations are politically motivated and go against the principles of humanitarian cooperation.
“The restrictions imposed by the U.S. authorities complicating RDIF efforts on the international promotion of the Russian vaccine products, have been lobbied by a number of large Western pharmaceutical companies. As a result of such unfair competition, billions of people around the world may be deprived of access to effective and safe Russian-made vaccines,” RDIF said in the statement, which was e-mailed to BioSpace.
Earlier this month, a WHO official told Russian news agency Tass that the global health organization had been planning a visit to the vaccine manufacturing facilities in Russia. Now, it’s unknown if that visit took place ahead of the Russian attack on Ukraine.
Russia has been pushing for authorization in multiple markets across the globe. Days ago, the government of the Republic of Kazakhstan authorized the use of the Russian vaccine for adolescents aged 12-17. It was the first country outside of Russia to make such an authorization for pediatric patients, the RDIF said.
Now, with the invasion of Ukraine, some of those efforts have been stymied. This week, the government of Bavaria announced that even if the EMA authorized the use of Sputnik V for member countries, the shot would not be available in the Free State of Bavaria. That is an about-face from one year ago when the government of Bavaria signed a letter of intent with the RDIF to secure 2.5 million doses of the Russian vaccine once approved by the EMA.
“It is inconceivable from our point of view that this project can now be realized. It is over," Markus Soeder, premier of the southeastern German state said, according to Reuters. Soeder cited the attack on Ukraine as the reason.
Reuters noted that the Russian pharmaceutical firm R-Pharm set up a production facility in Bavaria ahead of the EMA approval in order to create regional manufacturing capacities in Germany, which had also been in negotiation with the Russian government for vaccines.
With tightening economic sanctions against Russia from western countries in response to the invasion, it’s unknown whether or not that will limit the country’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.
The Sputnik V vaccine is an adenoviral vector vaccine that was developed by Moscow’s Gamaleya Institute. The vaccine has been genetically designed to infect cells in order to make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19. Data has shown that the vaccine produces a strong and lasting immune response against COVID-19, including the Omicron strain. Russia has touted data from a comparative study in Italy that showed Sputnik V demonstrated more than two times higher titers of virus-neutralizing antibodies to the Omicron variant than two doses of Pfizer’s mRNA vaccine. Sputnik V has been authorized in 71 countries totaling a population of over 4 billion people, RDIF noted.
While the vaccine has shown efficacy against the virus, several governments around the globe, including the United States and Ukraine, have said they will not allow foreigners who received the Sputnik V vaccine into the country without proof of a negative COVID-19 test. Both the Ukraine and U.S. governments have demanded inoculation from a vaccine approved by the WHO. In a report last fall, Reuters noted that the Ukrainian government refused to buy the Sputnik V vaccine and sought international aid to secure vaccines manufactured elsewhere.