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Fauci says regulators promise politics will not guide vaccine timing--Reuters interview
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WASHINGTON (Reuters) - U.S. regulators have assured scientists that political pressure will not determine when a coronavirus vaccine is approved even as the White House hopes to have one ready ahead of the November presidential election, the country’s leading infectious diseases expert Anthony Fauci said on Wednesday.
“We have assurances, and I’ve discussed this with the regulatory authorities, that they promise that they are not going to let political considerations interfere with a regulatory decision,” Dr. Fauci told Reuters in an interview.
“We’ve spoken explicitly about that, because the subject obviously comes up, and the people in charge of the regulatory process assure us that safety and efficacy is going to be the prime consideration,” he said....
“I’m certain of what the White House would like to see, but I haven’t seen any indication of pressure at this point to do anything different than what we’re doing,” said Fauci, director of the National Institute of Allergy and Infectious Diseases.
“I mean obviously they’ve expressed: ‘Gee, it would be nice, the sooner the better.’”
Trump has suggested publicly that a vaccine could be ready long before the end of the year.
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FDA commissioner: No matter what, only a safe, effective vaccine
...At the Food and Drug Administration and our parent agency, the Department of Health and Human Services, we recognize the vital importance of vaccine development. The framework in the United States to support a covid-19 vaccine is now in place. Testing is underway and manufacturing capacity is rapidly expanding. But let’s be clear: The development effort must adhere to standards that will ensure any covid-19 vaccine’s safety and effectiveness...
Large-scale clinical trials already have begun for several promising vaccine candidates. The data from these trials will enable the scientists at the FDA to determine which of these candidates has the greatest potential to provide protection from the virus, what the possible side effects are and how long immunity is likely to last. FDA scientists will need the information to decide whether approval of the vaccine for general use is justified. This fall, we expect to start identifying which vaccine candidates are truly viable....
I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment...
Once FDA scientists determine that a covid-19 vaccine candidate meets the appropriate regulatory standards for safety and efficacy, a pathway will be created by the government to make the vaccine available without delay. And, of course, after authorization or approval by the FDA, the safety of any vaccine will be closely monitored.
Since we at the FDA are the final arbiters of whether a particular vaccine is safe and effective, I cannot make any predictions about timing of an emergency use or final approval of a covid-19 vaccine. But I can attest that every FDA resource has been, and will continue to be, at the ready to facilitate clinical testing programs, and to review clinical data and manufacturing facilities. I can further provide assurances that any vaccine authorized for widespread use will meet the appropriate standards for quality, safety and efficacy....