Alright -- I finally have some time to type.
In regards to the vaccine and Covid convalescent plasma (CCP) donation.
When the vaccines first rolled out, the FDA set guidelnes under the EUA for CCP that plasma collected post vaccination could NOT be labeled and utilizied as CCP. This is due to the nature of the immune response variation between natural infection and that triggered by the vaccine. CCP is also only authorized under an EUA and is very specific in what we are allowed to label and distribute/transfuse.
In Mid February - the FDA changed the guidance to allow for the labeling of CCP of those that were infected naturally AND had received the vaccine. However, they put alot of extra steps on the process. 1) the blood center had to know when the donor was positive for COVID19 by obtaining a copy of their confirmatory laboraty test. 2) They donor could not be greater than 6 months post infection, and 3) the center still had to do a qualitative and quantitative test on the plasma. Due to the complexity of collecting, compiling and storing this information alot of centers have just stuck with not collecting CCP from donors who have had the vaccine. They can still donate, red cells, plasma, platelets, we just can not label it as CCP for the use in treating covid patients.
In this time frame the FDA also revised the EUA on the transfusion side of when and how often physicians can transfuse a patient. They put the restriction that only high titer plasma can be utilized and narrowed the window as to when a patient was eligible to receive CCP.
These changes drastically changed the demand landscape for CCP. Where we were shipping 300+ doses per day in our service territory we went down to averaging about 30 shipments per day.
Because of this demand change, our blood center now has a strong supply of high titer CCP that could last us about 4-5 months at the current use rate. Blood centers have also been working with the FDA to establish a national stockpile, stored at local centers but shareable across the country in the event of another surge. Currently we estimate over 40,000 doses of CCP in the stockpile. This product has a 1 year shelf life in its frozen form, and must be transfused within 5 days of thawing.
Due to this shift, and the decrease in cases, our blood center stopped collecting apheresis CCP in mid March. WE are still testing all donations for antibodies, and any whole blood derived plasma that qualifies, we are segregating and storing in our freezer.
Our main driver for not collecting apheresis derived CCP is that we do not want to waste any donations. Other than patient safety, our highest priority is to be good stewards of the donations entrusted to us. Outdating products is a disservice to the donor that gave their blood (literally) with the expectation that we get it to a patient that needs it. The second driver, is that a a not for profit blood center, we have a financial responsibility to ensure stability in our community. Apheresis collection has a higher cost due to the medical machines that draw the donation, and the training/time in employees. Whole blood collections meet two of our needs in collecting a red cell that can be used immediately and then a plasma that we can either use as FFP if it doesnt meet CCP guidelines or as CCP later on.
Onto a general update: Right now the blood supply nationally is very unstable. Even after a year of adjusting to covid, we still are not able to consistently meet patient demands.
We actually are collecting more than we have in the past year, but we are shipping at 100%+ 2019 levels. Cancer patients, heart patients, OB, trauma and all other patient needs have not subsided but our ability to collect to meet that demand is still significantly hampered by business/school/church covid mitigation policies.
Historically we collected 60%+ of our donation from mobile drives. We had about a 70% first time donor rate and then would convert those donors to neighborhood fixed sites. Post Covide, we are collecting about 55% in our fixed sites and 45% in mobiles. The biggest issue is that we aren't seeing the first time donors like we used to, and we are missing out tremendously in the 16-25 year old range due to school closures, remote learning, or closed campus policies. Unfortunately, blood drives have been seen as just another extracurricular activity as opposed to the essential community operation that they truly are.
in Texas, the snowstorm didn't help anything by shutting down operations fro 5-10 days, depending on what area of the state you are in. Our blood center lost appx. 6000 donations during that storm that put us in a hole, we are still trying to work out of. With summer coming up, we are concerned that we will continue to be in a constant appeal mode just to meet daily demand.
Alright - thats my $.02 and update in regards to CCP and the general blood supply.
