PROVIDENCE, R.I. (WPRI) — The U.S. Food and Drug Administration (FDA) released updated guidance regarding donating convalescent plasma, which is taken from those who have recovered from COVID-19.
The newly released guidance states COVID-19 convalescent plasma should not be collected from individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial, or received an authorized or licensed COVID-19 vaccine.
There are some exceptions, including if the individual has:
- Had symptoms of COVID-19 and a positive test result from a diagnostic test approved, cleared, or authorized by FDA, AND
- Received the COVID-19 vaccine after diagnosis of COVID-19, AND
- Are within 6 months after complete resolution of COVID-19 symptoms.
The FDA says this is to ensure any COVID-19 convalescent plasma collected from donors contains sufficient antibodies directly related to their immune response to COVID-19 infection.
The agency noted the administration of COVID-19 vaccines for the purpose of boosting the immunity of convalescent plasma donors would need to be conducted within a clinical trial.
According to the National Institutes of Health, which is recruiting for a clinical trial on the matter, convalescent plasma contains antibodies that can recognize and neutralize SARS-CoV-2, the virus that causes COVID-19, as well as other components that may contribute to an immune response.
The investigational convalescent plasma is intended for the treatment of hospitalized patients with COVID-19.
The Red Cross says it is following FDA blood donation eligibility guidance for those who receive a COVID-19 vaccination, and deferral times may vary depending on the type of vaccine an individual receives.
“Everything is still so new. There is uncertainty of the quality of the antibodies as it relates to convalescent plasma,” Kara LeBlanc, director of marketing and media relations at the Rhode Island Blood Center said. “If that changes, and as they know more, FDA will update that guidance,” she added.
Those who test positive for COVID-19 and have recovered are eligible to apply to donate convalescent plasma to Rhode Island Blood Center if they have not received the vaccine.
“Right on the form is a question about the vaccine, if they did receive the vaccine, then that is an exclusion, so it makes it all the more important for us to identify the people who have naturally developed the antibodies and they’re willing to donate the convalescent plasma,” LeBlanc said.
LeBlanc says the blood center has been testing all regular blood donations for antibodies since Dec. 14, and will continue to do so through at least the end of this month.
“It may extend past that, we’re not sure yet, but I would encourage people to book appointments,” LeBlanc said.
RIBC says you may donate blood immediately after receiving the Pfizer or Moderna vaccine as long as you are feeling well and all other donor criteria are met.
“Blood donations, platelet donations, they are needed just as much, and there is no deferral period if you receive the Pfiizer vaccine or the Moderna vaccine for donating regular blood and platelets,” Leblanc said.
RIBC notes if you received an “attenuated virus vaccine,” such as AstraZeneca, you must wait two weeks to donate after being vaccinated, and as long as you are feeling well and all other donor criteria are met.
Currently, only Pfizer and Moderna’s COVID-19 vaccines have been given an Emergency Use Authorization by the FDA.
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