“CDC urgently requests your assistance in expediting applications for these distribution facilities,” Dr. Robert Redfield, director of the CDC, wrote on August 27, “and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
“The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” he asserted in the letter, which was obtained by McClatchy DC.
“The requirements you may be asked to waive in order to expedite vaccine distribution will not compromise the safety or integrity of the products being distributed.”
Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, explained to Kaiser Health News on Tuesday that anticipated vaccine turnaround is contingent on safety and efficacy concerns raised by the Data and Safety Monitoring Board, an independent body composed of non-governmental employees.
"If you are making a decision about the vaccine, you'd better be sure you have very good evidence that it is both safe and effective," Fauci said. "I'm not concerned about political pressure."
Following approval, Fauci said researchers would then have a “moral obligation” to close the trial study and distribute the vaccine - first to all active study participants and then to the greater US population.
Dr. Eric Topol, editor-in-chief of Medscape, wrote on Monday that he wanted to remind US Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn of the federal agency’s mission statement.
“The emphasis here is on accurate, science-based information. Since you were sworn in on December 17, 2019, you have serially demonstrated your willingness to deviate from this bedrock premise,” he wrote, citing the FDA commissioner’s swift granting of an Emergency Use Authorization for hydroxychloroquine amid US President Donald Trump’s initial push of the drug as a COVID-19 treatment.
Due to the chief’s willingness to approve drugs “without any sufficient or meaningful supportive evidence,” Topol called on Hahn to either be honest with the public about COVID-19 vaccine development progress or let someone who can do such fill his position.
