I’m sure you’ve heard about convalescent plasma at this point in the pandemic, but do you know what it is, how it works, and where it comes from? Also, why is there controversy surrounding this therapy? Let’s dive in.

So what is convalescent plasma? Plasma is the liquid part of blood which contains all the blood cells and other components. Convalescent plasma is the plasma from someone who has been previously infected with COVID-19 that is separated out from their blood. Like I have discussed in previous posts, when you are infected with COVID-19, you develop antibodies which fight the virus. These antibodies then float around your blood in the plasma. When this plasma is taken from someone who was previously infected with COVID-19 and then infused into an actively sick individual, those antibodies are thought to help fight the infection. This premise has been derived from other infectious diseases (H1N1, SARS, MERS, etc) which had been historically treated with convalescent plasma.

How is it made? Well... You! Maybe not you specifically, but when a person is infected with COVID-19, you create antibodies; we’ve already established this. How is this obtained? Well you show up to the appropriate location, meet criteria to be a candidate for donation, an IV line is placed in your arm, some of your blood is removed, filtered through a machine that separates out the plasma, and then the blood is returned to your body. Easy peasy… Each donation can be used for about three to four doses. So why does this matter?

Since the pandemic began, we have been racing to find a “miracle cure” for COVID-19. As those of us in science and medicine know, a cure-all for such a novel infectious disease in such a short time is unlikely, however therapies can be created to improve symptoms, reduce the duration of said symptoms, or reduce mortality. One such therapeutic option which has gained traction since its initial suggestion is this convalescent plasma. Recent trials out of the Mayo Clinic involving over 35,000 patients show convalescent plasma is relatively safe and has some initial evidence to suggest a reduced mortality rate in severely-ill individuals. While this sounds promising, it is an open labeled study and not placebo controlled. Also, the preprint paper has yet to be peer-reviewed; this leaves a lot of crucial information to yet be known and gives a false sense of hope. As of Sunday, 8/23/20, the FDA’s, Dr. Hahn, announced EUA (emergency use authorization) for this therapeutic option. This was meant to expand its use outside of compassionate use, however there is debate in the medical community about whether or not the evidence is sufficient enough to warrant the FDA’s EUA. Prior to this, providers could still order convalescent plasma for severely or critically ill patients in the hospital setting.

Dr. Hahn and Donald Trump claimed that it has a 35% reduced mortality rate however that is a relative percentage, not absolute. In other words, high dose plasma showed a 35% reduction in mortality when compared to low dose, but it was not compared to a placebo and it does not describe overall, absolute mortality reduction. Some studies have shown that antibody levels of infected individuals were similar or higher than the amount administered via plasma in other studies begging the idea that this may not offer any additional protection. Time to resolution of symptoms was around 6-10 days, which could have been a normal course of the infection and completely up to chance. Adverse reactions have been rare but include allergic reactions and heart/lung complications which are universal for all plasma infusions. International studies have come to similar conclusions; convalescent plasma has similar risks to any other plasma infusion however efficacy remains unclear. Study designs have been poor and no randomized, large scale, placebo-controlled trials have been performed anywhere in the world as of yet. The data appears to have been cherry picked to some degree and there are some concerns that the EUA was pushed for political reasons. Sadly, during a pandemic, strength of evidence is an evolving concept. Because of its safety and limited use to the inpatient setting through infusion, EUA does seem lower risk than other suggested agents that are not as easily accessible to those in the outpatient setting (i.e. hydroxychloroquine). Many respected individuals in the scientific and medical community are concerned about this EUA.

Why is this EUA a point of concern? Well, let’s talk about what this truly means. Prior to the EUA, providers could still obtain use of convalescent plasma through compassionate use for their sick patients in the hospital. The concern lies in the fact that the majority of the scientific and medical community are not convinced by the evidence for EUA because the data is lacking and not convincing enough to determine risk vs. benefit. I understand that this is a unique situation, a once-in-a-century pandemic which has traveled the world causing significant morbidity and mortality. It’s safety is fairly convincing and I would agree that a severely ill or critically ill patient in the hospital may benefit from its use with low risk of adverse effects. However, before a respected, federal, medical institution makes a strong recommendation that a treatment is effective (president’s claim), it should have sound science to back up that claim. The FDA’s website still states that this therapeutic has not been proven to be effective or safe at this time and further investigation is needed. This does give me pause and perks my ears up. Because of this, I do fear there may have been political motivations behind this decision. This is especially concerning to me when the president sends out a tweet stating that the FDA is plotting against him for political reasons. With all of this said, I am beginning to worry. I fear that as the election nears, there will be a large push for the COVID-19 vaccines to be pushed prematurely through phase 3 trials to EUA. If a vaccine is rushed and the evidence is not convincing, I personally would not take the vaccine, so I would not expect anyone else to do so either. This would compromise all scientific credibility and further worsen the distrust in vaccines. This is not an anti-Trump statement but a defense of the scientific method and clinical perspective from a medical provider. This is a slippery slope we cannot start sliding down. Trump claims those at the FDA don’t share his “sense of urgency” yet this comes from the same man who claimed this was a hoax and it would just “disappear.” Why would individuals at the FDA log-jam a potential therapeutic when their own friends and family may need it one day if infected with COVID-19 and could then not obtain it. It just doesn’t make sense.

I have seen science and medicine thrown in the trash in the past few years as a result of partisanship and political motivations. From ignoring climate change science, reproductive health, and public health, our government has pushed aside common knowledge and scientific understanding. As someone who has worn many hats in both scientific research and clinical medicine/academics, the sheer ignorance to the scientific method by the highest members in our government and the general public infuriates me. I beg you all, please understand that it is okay for scientists to be proven wrong by new information and to change their views based on this data. If that happens, you are witnessing the beauty of the scientific method. It is the same reason why we were telling people not to wear masks at the beginning of this until we understood how this disease spreads and changed our recommendations based on science.

So having said all this, I understand that without convalescent plasma, we cannot study it further to see if it actually helps save lives. Therefore, if you have had COVID-19, PLEASE visit the FDA’s website to see how you can donate your plasma for clinical use.

As always, stay well and be safe!