Plasma for COVID-19 treatment

FDA Authorizes Plasma for COVID-19 Treatment

    
            COVID-19, which has been spreading across the globe since March, has affected the lives of Americans for over six months. Many people, including the President, are eager to eliminate the virus after a dreadful 6 months of rising cases and quarantine. To their dismay, hopes of eliminating the virus by Easter and then by August, seemed to turn into an unreachable dream for Americans. With cases rising and no sure vaccine or treatment for the virus, a future without COVID-19 seemed further and further away. Yet, this Sunday on August 23, 2020, the U.S. Food and Drug Administration authorized the first treatment for COVID-19: convalescent plasma. While the plasma has only been authorized for emergency use, many people see this authorization as progress towards eliminating the virus. However, others believe that the plasma is not as effective, and that the FDA was pressured by Trump to authorize treatment for COVID-19 to provide a sense of achievement after a bleak 6 months of quarantine. This post will be looking into the details of the convalescent plasma and how effective it is in treating the coronavirus.

What is Convalescent Plasma

            Convalescent plasma is the liquid part of your blood that contains antibodies, which fight off COVID-19 by attaching themselves to antigens (like the coronavirus) and destroying them while producing new antibodies to repeat the process. Once the convalescent plasma is injected in a patient's body, it kickstarts the patient's immune system by producing antibodies until the patient can generate their own. Convalescent plasma is only effective if it comes from an individual that has recovered from COVID-19. This way, the antigens in the plasma will have memory of previous contact with the coronavirus and can generate more powerful antibodies at a faster rate.

Is the Plasma Effective

            Convalescent plasma has been used for COVID-19 for many months. A study conducted at the Mayo Clinic, where over 70,000 COVID-19 patients have received convalescent plasma, produced results that suggest the plasma is effective. According to results from the study, convalescent plasma reduces COVID-19 mortality rate by 35%. Patients who benefited most from the plasma were generally under the age of 80 and not receiving artificial respiration. While 35% is a major decrease of mortality rate, some are still skeptical. The study did not include a placebo group, was not randomized and hasn't yet been peer reviewed or published. However, the FDA commissioner Stephen M Hahn states that convalescent plasma "has the potential to help treat those who are suffering from the effects of getting this terrible virus". Hahn also assured that the FDA "will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.” The figure below shows data produced by the Mayo Clinic on the efficacy of convalescent plasma. Patients who produced more antibodies (higher titer level) through the plasma treatment had a significantly lower death rate (37% reduction) compared to those who produced less antibodies (lower titer level).

Emergency Use Authorization

The FDA has authorized the plasma for Emergency Use Authorization, or EUA. According to the FDA, EUA means that the convalescent plasma "may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks". An EUA " authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19", but is not the same as traditional FDA approval. Further research and studies on the efficacy of convalescent plasma will continue to be conducted as patients are being treated.

Treatment is not a Vaccine

It's also important to understand that the convalescent plasma is a treatment and not a vaccine. A vaccine is given to individuals who have not been infected with the virus. Vaccines prepare the immune system to fight off the virus, in an effort to prevent people from getting sick. Meanwhile, treatments are given to patients who are already sick/infected with the virus. Treatments help patients recover more quickly by lessening symptoms and helping to fight the virus. According to the FDA, convalescent plasma treatment "may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients."

Sources

1.  Commissioner, Office of the. “FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration's Fight Against Pandemic.” U.S. Food and Drug Administration, FDA, www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment.

2. Treisman, Rachel. “FDA Authorizes Convalescent Plasma As Emergency Treatment For COVID-19.” NPR, NPR, 23 Aug. 2020, www.npr.org/sections/coronavirus-live-updates/2020/08/23/905277083/fda-authorizes-convalescent-plasma-as-emergency-treatment-for-covid-19.

3. Nicholas Florko, et al. “FDA, under Pressure, Authorizes Blood Plasma as Covid-19 Treatment.” STAT, 24 Aug. 2020, www.statnews.com/2020/08/23/fda-under-pressure-from-trump-expected-to-authorize-blood-plasma-as-covid-19-treatment/.