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Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said in an exclusive interview on “Sunday Morning Futures” that the agency has “been working with vaccine manufacturers for weeks now.”
Hahn made the comment after host Maria Bartiromo asked him, “If the Chinese were to create a vaccine in six months or less and they release it at scale to the U.S., is the FDA ready to quickly review that data to make this vaccine available to the United States?”
“We are prepared to look at any data around any medical product and in particular vaccines because that’s obviously the answer for the next season,” Hahn said.
“What I can assure the American people is that we will look at all the data and science, it’s our job to make sure that that data and science show us that a vaccine, in this particular case, is safe and effective,” he added.
Hahn then pointed out that the FDA has been working with vaccine manufacturers for weeks.
Currently, there is no known specific medicine to treat the novel coronavirus.
“A candidate vaccine was put into clinical trial several weeks ago, and that is the beginning of the process,” Hahn said on Sunday. “This is record speed for the development of a vaccine, but we’ll look at data from any source, but we will ensure, this is our job, the safety and effectiveness of any medical products including vaccines.”
On Friday, in a news release, the FDA announced that the agency is continuing to “play a critical role in accelerating medical countermeasures to treat and prevent COVID-19.”
“As part of the response to this pandemic, the agency is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood,” the release said. “These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.”
The products can be administered to people diagnosed with COVID-19, according to the FDA, which added that currently there is “limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness.”
The FDA stressed that that is why the “evaluation of these therapies in the context of a clinical trial and expanded access program is so important.”
On Sunday, Bartiromo brought up prophylaxis, defined as the prevention of a specific disease by studying the biological behavior and transmission of its causative agent and then applying a series of measures against it.
She asked Hahn, “How close are you in terms of finding the proper prophylaxis right now so we can get a shot and get immunity for 60 to 90 days to eventually open up the economy again even if it’s temporary?”
Hahn acknowledged that “we absolutely need to get back to work” and need to balance that with the public health issues.
Her question comes as government leaders have shut down much of the American economy in an attempt to slow the spread of the novel coronavirus.
Hahn then brought up that the FDA has been working on convalescent plasma for the past two months.
“What that means is we take plasma from a patient who has recovered from COVID-19, it has all of the immunity in there, and then we can give it to someone who is sick,” Hahn explained.
He added that “once we determine that that’s safe, effective, we then move to … hyperimmune globulin.”
Hahn explained that that process involves pulling plasma “from a lot of recovering patients, manufacture it, scale it up and give it as a shot.”
He went on to say that hyperimmune globulin can work as a therapeutic and potential treatment, but stressed “we have to study it and we’re doing this quickly.”
Hahn also said “that there are manufactures, great companies in the U.S. that have a lot of experience develop[ing] what we call monoclonal antibodies, so that’s actually genetically engineered antibodies, different from taking it from a patient but against the coronavirus, and we have been working with them for several weeks also, to try to scale that up … as a bridge to get to a vaccine.”
When asked if there are any drugs that are currently in short supply in America given some are imported from overseas including China, Hahn said, “Right now, we don’t have any evidence that there’s a drug in short supply because of anyone blocking the active pharmaceutical agreement ingredients coming to us.”
He added that the FDA is “monitoring that very closely.”
“I can tell the American people that critical medications are available, but there are spot shortages because of increased demand, so we are working very closely with domestic and international suppliers to increase the supply of those,” he explained.
Hahn added, “We absolutely must address the issue of redundancy in our manufacturing, and we must absolutely make an effort to have domestic manufacturing as well.”