“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” Fauci said to ABC News correspondent Deborah Roberts, who is moderating the event. “I seriously doubt that they’ve done that.”
Russia has been hinting that it is progressing rather quickly on a vaccine candidate, and at the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow where it is being developed some of the researchers even suggest that they began testing it on themselves before the first phase human trials began a month later.
However, Gamaleya has not published any results from the human trial which will typically involve three phases that are designed to test for safety, efficacy, and dosage. Additionally, Gamaleya has not released any preclinical research involving animal models or even experiments using cells that were raised in petri dishes.
Other Russian officials have said that phase three trials are still ongoing, and the Russian DIrect Investment Fund which is financing the vaccine told the Associated Press that the advanced trials were scheduled to begin August 12, 2020 across several countries. Upon investigation the Assocaied Press could not find any documentation in the Russian Health Ministry’s records citing these trials had even been approved.
Despite the lack of published information the Russian president says that the country’s health regulators are ready to approve a vaccine for widespread use in the nation. “We have to be grateful to those who have taken this first, very important step, very important for Russia and for the entire world,” Putin said in a statement released today by the Kremlin.
Due process states that phase three trials are crucial for validating if a drug or vaccine is ready for widespread distribution. This is the final step in testing that is designed to identify the safest doses for the mass public and this can only be determined by giving it to a diverse group of thousands of people over a long period of time. The safety and the degree to which a drug or vaccine works is also determined in this stage of testing.
A study conducted by the Massachusetts Institute of Technology in 2018 suggests that only 1 in 3 vaccines will make it through phase three trials to establish a recommended dosage while meeting established safety and efficacy standards. In American the FDA has stated that it will only approve a COVID-19 vaccine if it has at least 50% efficacy.
“We have half a dozen or more vaccines,” Fauci said. “So if we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to. But that’s not the way it works.”
Fauci said that people are threatening his life inresponse to his guidance over COVID-19 and that they “terribly harass my wife and my children with phone calls,” Fauci said. “It seems inconceivable … that when you’re trying to promote public health principles to save people’s lives and keep them healthy, that there’s such divisiveness in the country that that’s interpreted to be so far from your own way of thinking that you actually want to threaten the person.”
Although not condoning violence, the divisiveness was inevitable. For instance an initial 30 day shut down was extended to an additional month shutdown to flatten the curve. But this is not consistent nationwide and as it keeps getting extended with more mandates being implemented and threats of even further extensions and stricter mandates in certain states. The lack of coherent comprehensive leadership is more than apparent with all the flip flops in information also being an issue, then there is all the faulty testing, widespread inaccurate reporting, and censorship, it all adds up.
When it comes down to it people are scared, confused, and are becoming more and more frustrated which is only being amplified as people are running out of money. Americans are looking ahead at the very real likelihood of their jobs not being there for much longer as the list of businesses shutting down and declaring bankruptcy continues to increase at an alarming rate, especially in certain states with more strict governors. This is a very trying time indeed, one that needs to improve sooner rather than later.
