On August 23 the Food and Drug Administration (FDA)approved an Emergency Use Authorization (EUA)* for COVID-19 convalescent plasma for patients with COVID-19 treatment.
But in September, the National Institutes of Health (NIH) stated that: “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19. “
Сonvalescent Plasma For Patients With COVID-19 Treatment
According to the inside research by NIH – “Among patients who were not intubated, 11% of those who received convalescent plasma with high antibody titers died within 7 days of transfusion compared with 14% of those who received convalescent plasma with low antibody titers. Among those who were intubated, there was no difference in 7-day survival.
Although this data suggests that convalescent plasma with high antibody titers may be beneficial in no intubated patients, uncertainty remains about the efficacy and safety of convalescent plasma due to the lack of a randomized control group and possible confounding in the Mayo Clinic’s EAP. Additionally, antibody levels in currently available COVID-19 convalescent plasma are highly variable, and assays to determine the effective antibody titers remain limited.”
All this information met with the appropriate response. Eric Topol, MD, the editor-in-chief of Medscape, said in his letter to Stephen Hahn, MD, commissioner of Food and Drugs on December 17, 2019 – “You have one last chance, Dr Hahn, for saving any credibility and preserving trust in the FDA at this critical juncture amidst the pandemic. You need to organize a press conference and tell the truth. Tell Americans exactly how you were pressured to make a breakthrough announcement. Tell all of us how you completely misrepresented the facts about convalescent plasma, and not hide this with the obscurity of technical terms such as relative and absolute differences. Tell us that you are capable and worthy of this pivotal leadership position and that you will not, under any condition, authorize a SARS-CoV-2 vaccine approval before the full Phase 3 completion and read-out of a program.”
Against this background AstraZeneca’s vaccine candidate, AZD1222, has expanded into a phase 3 clinical trial.
30,000 Adult Participants Testing Safety Of AZD1222
At that moment, trial centers across the US are recruiting up to 30,000 adults aged 18 years or over. Volunteers can be diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine. Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
AstraZeneca continues supply to Russia, South Korea, Japan, China, Latin America and Brazil etc., and hopes to see late-stage trials results later this year.