FDA explains convalescent plasma donor eligibility for COVID vaccine recipients
The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.(RELATED: Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates, Regulatory Focus 3 September 2020).
With two vaccines authorized for emergency use in the US and others in clinical development, FDA says that convalescent plasma should not be collected from individuals who received an investigational COVID-19 vaccine in a clinical trial or who received an authorized or licensed COVID-19 vaccine, unless they meet specific criteria detailed in the guidance. (RELATED: FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020; FDA issues EUA for Moderna COVID vaccine, Regulatory Focus 18 December 2020).
For vaccine recipients to be eligible, FDA says they must have had symptoms of COVID-19 and a positive test result from an FDA-approved, -cleared or -authorized diagnostic; received the vaccine after being diagnosed with COVID-19; and are within six months of complete resolution of COVID-19 symptoms.
FDA explains that the criteria are “to ensure the COVID-19 convalescent plasma collected from Donors contains sufficient antibodies directly related to their immune response to COVID-19 infection.” The previous version of the guidance, issued in November before any COVID-19 vaccines had been authorized by the agency, said that COVID-19 convalescent plasma should not be collected from those who received an investigational COVID-19 vaccine, “Because of the uncertainty regarding the quality of the immune response produced by such investigational vaccines.”
The agency also says that the administration of COVID-19 vaccines to boost the immunity of convalescent plasma donors “would need to be conducted within a clinical trial under IND.”
In addition to explaining donor eligibility for COVID-19 vaccine recipients, FDA has extended its enforcement discretion policy regarding investigational new drug application (IND) requirements for convalescent plasma through 31 May 2021. The enforcement discretion policy allows for the use of investigational convalescent plasma to be used to treat hospitalized patients with COVID-19 without meeting conditions of the EUA without requiring an IND under certain circumstances. This is the second time the agency has extended its enforcement discretion policy for convalescent plasma since detailing it in September 2020.
FDA says the policy “should provide blood establishments adequate time to develop the necessary procedures to manufacture COVID-19 convalescent plasma under the conditions of the EUA, and if unable to develop such procedures, only administer investigational convalescent plasma under an IND.”
FDA