FDA authorizes COVID-19 convalescent plasma for hospitalized patients

The Food and Drug Administration yesterday issued an emergency use authorization for investigational convalescent plasma to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients.

COVID-19 convalescent plasma is human plasma collected by FDA-registered blood establishments from individuals whose plasma contains anti SARS-CoV-2 antibodies. Based on the available scientific evidence, FDA said it was reasonable to believe the treatment may reduce COVID-19 severity or length of illness in some hospitalized patients, and that the known and potential benefits outweigh the known and potential risks. Information derived from ongoing clinical trials “will continue to inform this risk benefit assessment,” the agency said.

For more on the EUA, see the fact sheets for health care providers and patients.

In related news, the Department of Health and Human Services’ Office for Civil Rights today issued amended guidance on how the Health Insurance Portability and Accountability Act Privacy Rule permits covered health care providers and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate convalescent plasma.

According to OCR, the updated guidance clarifies how HIPAA permits health plans to contact their beneficiaries about plasma donation opportunities.

The guidance also emphasizes that, without individuals' authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals, OCR said.