FDA opens door to emer­gency use of con­va­les­cent plas­ma from re­cov­ered Covid-19 pa­tients

One po­ten­tial treat­ment for Covid-19, known as con­va­les­cent plas­ma, may be de­rived from pa­tients who have al­ready re­cov­ered from the dis­ease, and the FDA said Tues­day that it will help to pro­vide ac­cess to it for pa­tients with se­ri­ous or im­me­di­ate­ly life-threat­en­ing Covid-19 in­fec­tions.

The idea be­hind the treat­ment is that plas­ma col­lect­ed from pa­tients re­cov­er­ing from Covid-19 may con­tain an­ti­bod­ies to the virus that might be ef­fec­tive against the in­fec­tion. New York Gov. An­drew Cuo­mo (D) said yes­ter­day that some crit­i­cal­ly ill pa­tients would be able to ac­cess con­va­les­cent plas­ma in some cas­es.

Al­though FDA says it’s im­por­tant to de­ter­mine, via clin­i­cal tri­als, the safe­ty and ef­fec­tive­ness of con­va­les­cent plas­ma be­fore rou­tine­ly ad­min­is­ter­ing it to pa­tients with Covid-19, the agency said it will al­low the use of sin­gle pa­tient emer­gency In­ves­ti­ga­tion­al New Drug Ap­pli­ca­tions (eINDs) to ob­tain ac­cess to the in­ves­ti­ga­tion­al plas­ma. Such eINDs can be sub­mit­ted to FDA via email and the agency says it can pro­vide time-sen­si­tive re­spons­es in four to eight hours.

Stephen Hahn

At the White House last week, FDA Com­mis­sion­er Stephen Hahn said the agency is “re­al­ly push­ing hard to try to ac­cel­er­ate” the use of con­va­les­cent plas­ma. He added: “If you’ve been ex­posed to coro­n­avirus and you’re bet­ter and you don’t have the virus in your blood, we could col­lect the blood. Now, this is a pos­si­ble treat­ment; this is not a proven treat­ment — just want to em­pha­size that. Col­lect the blood, con­cen­trate that, and have the abil­i­ty, once it’s pathogen-free — that is, virus-free — to be able to give that to oth­er pa­tients. And the im­munoglob­u­lins — the im­mune re­sponse — could po­ten­tial­ly pro­vide a ben­e­fit to pa­tients.”

FDA al­so says that Covid-19 con­va­les­cent plas­ma must on­ly be col­lect­ed from re­cov­ered in­di­vid­u­als (com­plete res­o­lu­tion of symp­toms at least 14 days be­fore a do­na­tion) and if they are el­i­gi­ble to do­nate blood. The re­quired test­ing must be done, FDA says, while al­so out­lin­ing how it de­fines what “se­vere or im­me­di­ate­ly life-threat­en­ing Covid-19” means (see the link at the bot­tom for more de­tails).

In ad­di­tion, FDA is work­ing with the Na­tion­al In­sti­tutes of Health and the Cen­ters for Dis­ease Con­trol and Pre­ven­tion to de­vel­op mas­ter pro­to­cols for use by mul­ti­ple in­ves­ti­ga­tors in or­der to co­or­di­nate the col­lec­tion and use of Covid-19 con­va­les­cent plas­ma.

The use of con­va­les­cent plas­ma was pre­vi­ous­ly stud­ied in oth­er pan­demics and epi­demics, in­clud­ing the 2009-2010 H1N1 in­fluen­za virus pan­dem­ic, the 2003 SARS-CoV-1 epi­dem­ic, and the 2012 MERS-CoV epi­dem­ic, FDA said.

A com­ment in the Lancet last month said that “sev­er­al stud­ies showed a short­er hos­pi­tal stay and low­er mor­tal­i­ty in pa­tients treat­ed with con­va­les­cent plas­ma than those who were not treat­ed with con­va­les­cent plas­ma.”

In­ves­ti­ga­tion­al COVID-19 Con­va­les­cent Plas­ma – Emer­gency INDs

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Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

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He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

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