Just a week after the US Food and Drug Administration released an emergency use authorization on the use of convalescent plasma in COVID-19 therapy, a panel from the National Institutes of Health stated that there is no evidence that backs the use of the therapy in COVID-19 patients.
The NIH panel also stated that doctors should not treat convalescent plasma therapy as a standard in the treatment of coronavirus patients until additional studies have been done and concrete evidence of its safety and effectiveness is presented.
On Tuesday, a statement was posted on the website of the NIH where dozens of experts that comprised the panel emphasized that there is insufficient data supporting the treatment. Thus, they have noted that they are unable to recommend either to support or to go against the use of the treatment.
The statement by the NIH opposes the stand of the Trump Administration which has hailed the FDA's approval for emergency use authorization of the treatment as a "major advance" and "historic."
Moreover, the statement from the NIH emphasized the need for an adequately powered randomized trial in order to determine if convalescent plasma treatment is indeed safe and effective for COVID-19 treatment. The panel also encouraged health care providers and public health professionals to participate in the trials.
Administration Praises Convalescent Plasma Treatment
During a news conference in the White House last week, President Trump announced that the authorization of convalescent plasma treatment was a step forward in the battle against SARS-CoV-2, the virus which causes COVID-19. He also noted that the move by the FDA will dramatically increase the accessibility of the treatment, CNN reported.
The timing of the FDA's approval has raised several suspicions that the organization has been pressured by the government into doing so. But Dr. Stephen Hahn, Commissioner of the FDA has repeatedly denied the allegations. However, the FDA Commissioner has also made comments about the data that supports the use of the said treatment that many have found misleading.
The NIH Panel
The panel that released the statement questioning the integrity of the treatment due to lack of supporting studies was led by National Institute of Allergy and Infectious Diseases head of research, Dr. Clifford Lane; Weill Medical College of Cornell University's Division of Infectious diseases chief, Fr, Roy Gulick; and NIH Critical Care Medicine Department chief, Dr. Henry Masur. The panel also emphasized that there is a lot more research needed to prove that the treatment indeed works.
They also stated that the currently available data do not support the claims of the treatment's effectivity, despite the promising response.
Moreover, the panel also stressed the possible long-term risks brought by the treatment, including affecting the body's immune response to SARS-CoV-2. It may also cause patients to be more susceptible to reinfection - something that has not been evaluated as of yet.
Moreover, the varying levels of antibodies in the recovered patients is also one of the reasons that the treatment is viewed as highly variable.
