President Donald J. Trump announced the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for convalescent plasma as a therapeutic treatment in COVID patients Sunday.
Convalescent plasma is the liquid part of the blood that contains COVID antibodies. Convalescent plasma given to COVID patients during research conducted since April by the Mayo Clinic has resulted in a 35% decrease in the incidence of death in the patients receiving the plasma, according to FDA Director Stephen Hahn.
The announcement is significant in Ohio where Republican Governor Mike DeWine has hinted for months at his hesitation to allow Ohioans to return to normal life until there is a vaccine.
The Ohio Star reached out to Governor DeWine’s team immediately following President Trump’s Sunday news conference.
Governor DeWine through his Press Secretary Dan Tierney said, “the Ohio Department of Health is reviewing today’s announcement. To clarify, the Governor has previously stated that we are in the current phase of the pandemic response and are living with the virus until we have a vaccine OR another effective treatment.”
The Ohio Department of Health (ODH) is led by Lance Himes who has been General Counsel to ODH for the past 15 years and is not a medical doctor, virologist or epidemiologist but an attorney.
The phrase ‘effective treatment’ deviates from previous statements from Governor DeWine and one of his top advisors – Dr. Andrew Thomas, Chief Clinical Officer at Ohio State University Wexner Medical Center.
For months Governor DeWine has warned that COVID is searching the land “looking for bodies” and we are not safe until we have a vaccine.
Dr. Andrew Thomas has been an advisor to Governor DeWine and his pandemic response team since inception and was a key contributor to the Ohio Public Health Advisory System (OPHAS).
Dr. Thomas was describing OPHAS during a July 16 press conference when he said “none of the counties are green. The reason none of the counties are green is no matter what county you live in, you are at risk for contracting COVID-19. There is activity to some degree across the entire state. Until we have a vaccine or until we have a pharmacologic medication treatment that is known to stop the incidence of the disease and the spread of the disease, no county really will be anything less than yellow.”
Convalescent plasma is not a vaccine nor is it a pharmacologic medication. Other pharmacologic interventions Redesivir and hydroxychloroquine have both been nixed as game-changers for Ohio’s executive branch and their band of bureaucrats.
During the presser all Americans who recovered from the virus were encouraged to donate plasma and to begin the process at www.coronavirus.gov .
Under the EUA, patients will have expanded access to plasma as a treatment for COVID.
FDA Director Stephen Hahn was questioned by the White House press corps about what an EUA means for convalescent plasma and about its true efficacy. Regarding the meaning of the EUA, Hahn said “[u]nder legal authority of Emergency Use Authorization it’s not approval, it’s an authorization that allows us to expand access to this – and our data, we knew we were going to continue to collect data for all of our Emergency Use Authorizations. For example, Remdesivir, which was authorized on May 1, we’re still collecting data and we will continue to do that with plasma as well. So it’s the nuances of the language around the authorization and the legal aspect.”
When asked by a reporter ‘So it’s a promising treatment but you couldn’t say it’s very effective just yet?’ Hahn responded, ‘So I would say if you are one of those 35 out of 100 people who these data suggest or show survives as a result of it, this is pretty significant to that person and their family.’
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