https://www.americanthinker.com/blog/2020/05/four_questions_senators_should_ask_redfield_and_fauci_on_tuesday.html
On Tuesday, health bureaucrats Dr. Robert Redfield, director of the CDC, and Dr. Anthony Fauci, director of NIAID, will testify at a hearing of the Senate Health, Education, Labor and Pensions Committee. Republican Senators should ask them four questions about their failures to expedite deployment of vaccines and test the successful HCQ-zinc treatment during the COVID-19 pandemic.
Vaccine question for Redfield: Why haven’t you invoked the Accelerated Approval Process to get Moderna’s Vaccine out right away?
During the H1N1 (Swine Flu) epidemic in 2009 when a Democrat was President, the CDC approved four vaccines just 7 weeks after clinical trials began by invoking the Accelerated Approval Process. Here are excerpts from the timeline on their website:
April 15. First human infection.
May 5. School closings affect 607,778 students.
July 22. Clinical trials testing the vaccines begin.
September 15. Four H1N1 vaccines approved for use by the FDA.
In this accelerated process, designed for epidemics, a single clinical trial phase determines whether a vaccine is safe and whether it creates the required antibodies. In vaccine terminology, the pathogen-specific antibodies developed by a vaccine are considered to be a “surrogate endpoint” permitting the vaccine to be deployed immediately, without Phase 2 or Phase 3 studies. A “Phase 4” process begins after deployment to track the effectiveness and the side-effects of the vaccine.
On May 7, the FDA announced that the Moderna’s coronavirus vaccine had been approved to begin its Phase 2 trial. Since its Phase 1 clinical trial concluded successfully, it is safe for healthy people and able to produce a “surrogate endpoint.” As a result, it could be immediately deployed to healthy people in order to create the 60% herd immunity condition that prevents spread of an epidemic.
Moderna’s Phase 2 clinical trial is scheduled to end mid-summer which will determine whether the vaccine is safe for older people and other groups that would have high mortality rate should they contract COVID-19. If this trial is successful, use of Moderna’s vaccine could immediately be extended to those less-healthy groups.
There are several additional Covid-19 vaccines waiting in the wings, all of which could be tested quickly if the CDC would simply put the Accelerated Approval Process into place today, just as they did in 2009.