27 Aug 2020
Posted in Pharma
EUA for convalescent plasma likely being used as political spin and more robust data is required, says GlobalData
Following the news that the FDA granted an EUA for convalescent plasma as a treatment option for COVID-19;
Angad Lotay MPharm, Infectious Diseases Analyst at GlobalData, offers his view:
“Granting convalescent plasma an EUA was a critical decision in which the public should be able to have confidence. However, the data was presented during a political campaign. If the FDA’s decisions are seen through the lens of politics, it is going to make it very difficult for people to trust that what the agency is doing is based on science, ultimately hurting the nation’s response to the virus. We have already seen worrisome discord in the community over the use of chloroquine/hydroxychloroquine because of a mix of bad science and politics, and any further confusion stemming from questionable decisions from the FDA will only lessen public confidence in the decision makers.
“Prior to the campaign, US public health policy officials Anthony Fauci and Clifford Lane argued that the emerging data for convalescent plasma was not strong enough to support approval. It was reported that FDA Commissioner Stephen Hahn said that the treatment has been associated with a 35% improvement in survival. While this sounds promising, this data was from an observational study with no comparison to a placebo. The claim also appears to be misrepresented, and, following backlash from the medical community, Hahn has walked back his claims.
“In my opinion, more sufficient data and robust clinical trials are needed in order to establish a true efficacy profile. Without this data, the use of convalescent plasma in COVID-19 patients is not yet settled science.