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

Sputnik, 08.09.2020

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."

The companies' joint press release was published by Businesswire.com on Tuesday.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented on the "pledge of safety" recently released by nine pharmaceutical companies.

"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. 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 said.

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. We also 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," Dmitriev concluded.