'Pledge of Safety by Major Pharma Companies Insufficient', Russian Direct Investment Fund CEO Says

© REUTERS / Dado RuvicA woman holds a small bottle labelled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration
A woman holds a small bottle labelled with a Vaccine COVID-19 sticker and a medical syringe in this illustration - Sputnik International
The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have "announced a historic pledge", outlining their commitment to upholding "the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines."

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented on the "pledge of safety" voiced by the aforementioned pharmaceutical companies in a joint press release published by Businesswire.com on Tuesday. 

"While welcome, we believe this pledge by some of the major pharmaceutical companies is insufficient, in that it does not discuss the lack of long-term studies on the carcinogenic effects and impact on fertility of newly-developed vaccine technologies, such as mRNA or the monkey adenoviral vector-based platform," Dmitriev said.

He pointed to the difference between the platform used by Russian scientists to develop a COVID-19 vaccine and those platforms that have been used by their colleagues abroad.

"Unlike the human adenoviral vector-based platform used in Russia’s Sputnik V vaccine, mRNA and monkey adenoviral vector-based platforms have not been studied over a long period of time. Since some of the companies developing these vaccines have taken the 'pledge of safety', we would like to stress that public health and safety requires not only short-term evidence of lack of serious adverse effects but also safety and efficacy proved by the results of long-term studies," Dmitriev added. 

He stressed a need for international companies to focus on long-term evidence concerning the potential side effects of candidate vaccines.

"While signing up to the 'pledge of safety', these companies are also pressuring the countries buying their vaccines into granting them full indemnification from lawsuits. We believe that international regulators should require long-term evidence of lack of serious adverse side effects when considering candidate vaccines for registration in their countries," Dmitriev said.

According to CEO of the Russian Direct Investment Fund, Russian experts believe that "pharmaceutical companies should take responsibility in their pledges for potential long-term adverse effects caused by the vaccines they produce, and make the risks publicly known, should people experience negative side effects after undergoing vaccination". 

Earlier this week, Mr Dmitriev offered a detailed response to criticism of Russia's coronavirus vaccine, Sputnik V, and answered the most frequently asked questions about the pioneer vaccine presented by the Gamaleya National Research Center of Epidemiology and Microbiology last month.

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