Valiant News exclusively reported on Thursday that the American Red Cross told us they will not accept blood from vaccinated patients for convalescent plasma (CCP) treatments in immunocompromised COVID-19 patients, despite FDA guidance encouraging it.
COVID-19 CCP treatment involves individuals who have recovered from the virus donating their blood plasma at blood banks, which then use it to create CCP that can be used in antibody treatments for those sick with COVID-19.
After recovering from the virus, an individual’s blood may contain high levels of anti-COVID antibodies, while some may have fewer antibodies. The most effective plasma, experts say, is taken from donors with high antibody levels, referred to as “high-titer” plasma.
Red Cross told Valiant News that vaccinated people – even those who later catch COVID-19 – will never have the “high-titer” levels needed to make convalescent plasma.
Valiant News specifically asked the FDA about the accuracy of Red Cross’ claims that “If a donor has had the COVID-19 vaccine, they will generate an antibody against the spike protein but not other viral proteins, which will only occur in the event of a COVID-19 infection.”
We also asked the FDA if it is currently scientifically or medically possible for the donated blood of a vaccinated person to be used for CCP, and if it has ever been accomplished in the United States.
The FDA did not answer the questions raised by Valiant News, instead reiterating their general guidance. They then turned us back toward the Red Cross and individual blood establishments.
Rather than confirm that vaccinated blood has ever been used to create effective CCP for COVID-19 treatments, the FDA reiterated the guidance that Red Cross already acknowledges, and that Valiant News had already reported on, by stating that vaccinated individuals “may be eligible” to donate CCP.
“An individual who has received a COVID-19 vaccine may be eligible to donate COVID-19 convalescent plasma (CCP). In January 2022, FDA updated its guidance, Investigational COVID-19 Convalescent Plasma, and provided recommendations that address when individuals qualify as convalescent plasma donors under the EUA, after receiving a COVID-19 vaccine,” the FDA told Valiant News.
Then, the FDA reiterated the eligibility requirements that vaccinated people would need to meet in order to donate CCP, without explaining if CCP has been ever created with the blood of vaccinated individuals whose so-called “breakthrough” infection symptoms had been completely resolved.
“In short, FDA recommends that vaccinated individuals should have had symptoms of COVID-19 and a positive test result, and should donate CCP within 6 months after their COVID-19 symptoms completely resolve,” the federal government told Valiant News.
The FDA then claimed that their guidance permitting vaccinated blood to be used for CCP is “intended” to ensure that donated CCP has high levels of anti-COVID antibodies, adding that CCP testing must take place to determine that it is “high titer” — without clarifying that vaccinated blood-derived CCP has actually been found to contain the necessary levels of anti-COVID antibodies, or if vaccinated blood-derived CCP taken from individuals, whose “breakthrough” infection symptoms have subsided, has actually been successfully used to treat COVID-19 in immunocompromised patients before.
“FDA’s recommendations are intended to ensure that CCP contains a wide range of antibodies resulting from the immune response to COVID-19. In addition, CCP must be tested for to determine that anti-SARS-CoV-2 antibodies are present in high amounts (i.e., high titer CCP),” the FDA said.
The FDA deflected back to the Red Cross and other blood establishments in response to the question Valiant News raised regarding the validity of Red Cross’ claims that the COVID-19 vaccines do not cover all the regions of the virus, nor produce antibodies against other viral proteins.
“Regarding your other questions, individual blood establishments may make their own determinations on whether to collect COVID-19 convalescent plasma. We therefore recommend directing your question to the establishments regarding their statements,” the FDA told Valiant News.
On Thursday, Red Cross explained to Valiant News that the reason they will not use vaccinated blood for CCP treatment is because the COVID-19 vaccine does not cover all the regions of the virus, nor do the vaccinations produce antibodies against what they described as “other viral proteins.”
In contrast, Red Cross Senior Social Media Relations Manager Emily Osment explained that a natural COVID-19 infection will generate antibodies against the coronavirus spike protein and other viral proteins, while the vaccines only produce antibodies against the spike protein.
“The Red Cross is currently only producing convalescent plasma from donations from individuals who are unvaccinated and have confirmed a previous symptomatic COVID-19 infection,” said Osment.
“This is because when an individual has been infected with a virus, they produce antibodies to multiple regions of a virus,” Osment continued. “If a donor has had the COVID-19 vaccine, they will generate an antibody against the spike protein but not other viral proteins, which will only occur in the event of a COVID-19 infection.”
The admission contradicted the organization’s social media posts directed towards book author Jennifer Sey, who claimed blood donation establishments weren’t using vaccinated blood for CCP treatments, and asked “Why can’t they use blood of vaxxed who also had Covid? Real question for MDs. What’s wrong with vaxxed blood?”
While updated FDA guidance allows donations from those who received a COVID-19 vaccine to be processed into convalescent plasma, it would require complex Red Cross system updates & delay our ability to meet immediate needs of immunocompromised patients with the virus. (2/3)
— American Red Cross (@RedCross) April 20, 2022
“While updated FDA guidance allows donations from those who received a COVID-19 vaccine to be processed into convalescent plasma, it would require complex Red Cross system updates & delay our ability to meet immediate needs of immunocompromised patients with the virus,” Red Cross replied — only to later admit to Valiant News that the reason was not due to bureaucratic complications but, rather, medical and scientific reasons.
As previously reported by Valiant News, the U.S. Food and Drug Administration (FDA) in February 2021 issued guidance barring the collection of CCP 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” to “ensure that COVID-19 convalescent plasma collected from donors contains antibodies directly related to their immune responses to SARS-CoV2 infection.”
The only exception was that vaccinated individuals were to have had received the vaccine after they were diagnosed with COVID-19 and been symptom-free for no longer than six months. Vaccinated people who did not meet the terms were deemed ineligible.
In January 2022, the FDA updated that guidance, revised their previous recommendations, and permitted CCP donations from individuals who were vaccinated prior to infection. The change allowed vaccinated people with so-called “breakthrough” infections to be CCP donors.
Thus, by currently not accepting blood from vaccinated patients for CCP treatments in immunocompromised COVID-19 patients, Red Cross is contradicting the FDA guidance that permits it.
It remains unclear whether CCP has ever been created from a vaccinated person’s blood.
Neither the Red Cross nor the FDA would confirm that the process has been successfully completed when asked by Valiant News.