In the global race for the coronavirus vaccine that has plagued humanity with 737,417 deaths, we are currently encountering 139 attempts, of which 28 are in the clinical evaluation phase, according to data from the World Health Organization. If you look closely at this list of facts, you will see that the Russian Gamaleya University has provided scientific data only for phase I. The WHO, reacting to Putin’s announcements about vaccine discovery, it called for the scientific data for the remaining phases (II and III when concluded) to be made public, so that the Organization could conduct safety and efficacy assessments to see if these announcements could justify a kind of “early positive evaluation” or if they are not enough.
Each country has its own organizational bodies that regulate the licensing of drugs, vaccines, etc. The evaluation regarding the effectiveness and safety of a coronavirus vaccine by the WHO is a kind of “quality assurance that will be made for any vaccine that is declared ready for use,” said United Nations spokesman Tarek Jasarevic, urging Russia to share the scientific data that makes the discovery ready to be used in a non-compulsory -as announced – level within the country and to deliver the vaccine in other countries from October on.
At the same time, as we look at the European Medicines Agency (EMA), which licenses pharmaceutical innovation in the EU, we see that the European Ombudsman, Emily O’Reilly, is also dissatisfied with the way the task force created by EMA to evaluate pandemic vaccines, operates. In a letter sent on July 29 to the Agency’s Executive Director, Guido Rassi, she called for more transparency and independence. More specifically, Ms. O’Reilly asked for them not to be the same experts who advise at an early stage, “before submitting” the 139 attempts to find a vaccine, as the experts who will evaluate the effectiveness and safety of those who reach the end of the innovation process.
