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FDA "will not be influenced by outside pressure" in developing a COVID-19 vaccine, Commissioner tells WWL-TV's Katie Moore

Four US companies conducting clinical trials of safety and effectiveness of potential coronavirus vaccine

NEW ORLEANS — Four American companies are currently conducting clinical trials, part of the race to develop a vaccine for the coronavirus, with half a dozen more in discussions with the U.S. Food and Drug Administration about whether or not they can take the next step in the process, the agency said.

"So far we have no evidence that the mutations are affecting the ability of a vaccine or antibodies to be effective against the virus. This is a constantly-evolving pandemic, but so far, our science tells us that we're on a good path," said FDA Commissioner Stephen Hahn in an interview with WWL-TV's Katie Moore Wednesday.

The development of a safe and effective vaccine is one of the keys to getting out of the pandemic, according to world health officials. This week Hahn and the FDA released new guidelines for companies to know what the agency will be looking for in order to grant the companies a license to produce the vaccine.

Among them, 50% efficacy, meaning, the data collected during clinical trials must demonstrate the vaccine helps prevent or lessen the severity of infection in half the people who are vaccinated.

Hahn said Wednesday that level should be considered the "floor" of a potential vaccine's effectiveness. 

The Washington Post reported last week that President Donald Trump has been pushing U.S. Health officials to speed up the timeline of vaccine development to get one approved as early as this fall.

"Has there been any pressure from the Trump administration to get this done before the election," Moore asked Hahn during the interview. 

"We do not at all feel pressure with respect to when this vaccine or if this vaccine gets approved or authorized. Let me make this clear. We have unbelievable talent at FDA. The American people can trust the scientists, nurses, doctors, who are on our vaccine team. They have been doing this for years. They will not be influenced by outside pressure. They will not be influenced by political pressure. They will make the best decision on behalf of the American people. We have a gold standard with respect to safety and effectiveness," he replied.

Critics have said vaccine development by the fall is unlikely, but members of the US Coronavirus Task Force have been consistent in saying it could be late this year a vaccine is ready for distribution.

Health officials have long said another key to getting out of the pandemic is finding effective therapeutics, drugs or treatments for those sickened by coronavirus.

Hahn said he was "hopeful" about the success of treating COVID-19 with convalescent plasma, the antibody-rich protein the blood of people who have already suffered through the disease and recovered. 

"Over 25,000 Americans have been treated on the expanded access program. We have early data that show that it's safe. I have a great deal of hope, although we do need to see what the data are on effectiveness, that this therapy could be the next one that comes out," Hahn said.

He went on to say right now, the FDA is overseeing 141 clinical trials to test the safety and effectiveness of drugs and therapies that could be used to treat COVID-19, with 300 more waiting to begin.

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