Dr. Fauci ‘cautiously optimistic’ about vaccine approval before year’s end.
There have been few clearer signs of the battle between the Deep State and the Trump administration than news and policies related to COVID19.
Recently, the Food and Drug Administration (FDA) indicated that it planned to announce stricter guidelines for the emergency authorization of vaccines. This would mean that any chance of approval for the use of several in the late stages of development before the election would be nixed.
The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process, the paper said.
According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of cases of severe COVID-19, the disease caused by the coronavirus, in patients treated with a placebo.
Clearly, the bureaucrats forgot that President Donald Trump is in charge of the executive branch of government. Trump indicated he is considering rejecting the move…for being a blatant political manipulation.
The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget.
“That has to be approved by the White House,” Trump said of the FDA guidance. “We may or may not approve it.”
Trump also suggested that the FDA’s decision to pursue stricter standards “was a political move more than anything else.”
Four vaccines are now in the final stage of clinical trials in the United States — studies that are designed to determine whether any of the shots are effective at preventing coronavirus infections.
Interestingly, Coronavirus Task Force member Dr. Anthony Fauci indicates he is “cautiously optimistic” about the chances of a vaccine being approved by the end of the year.
Dr. Anthony Fauci, the nation’s leading infectious disease expert, said on Wednesday that he and his team are “cautiously optimistic” about developing a coronavirus vaccine and predict it could be approved in November or December.
“We predict that sometime by the end of this year, let’s say November or December, we will know whether or not these are safe and effective,” Fauci said at a Senate Health, Education, Labor & Pensions Committee hearing.
“Early studies in animals and in human Phase 1 and Phase 2 indicate that individuals induce a response that is comparable to, if not better, than natural infection,” he said. “Right now, doses of this vaccine are being produced so they’ll be ready to be distributed.”
Meanwhile, four vaccine developers are moving forward quickly on Phase III large-scale trials.
Johnson & Johnson on Wednesday announced that it has begun phase three trials of its potential coronavirus vaccine, making it the fourth potential vaccine to begin the late-stage trials in the United States.
The move adds to the array of potential vaccines that are being tested, with the hope that multiple candidates will prove safe and effective and help meet the enormous national and international demand.
While the Johnson & Johnson vaccine is not furthest along in the timeline, trailing candidates from Pfizer, Moderna and AstraZeneca, it does have some potential advantages if it proves safe and effective.
Unlike some of the other potential vaccines, the Johnson & Johnson candidate requires just one dose, not two, which would make a vaccination campaign easier. It also does not require storage at extremely cold temperatures, unlike some of the other candidates.
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