Pfizer and BioNTech Vaccine Efficacy, Remdesivir officially FDA approved, and Bamlanivimab gains EUA

Over the previous month, there have been many exciting advances in the arena of COVID-19 clinical trials. To start, recently Pfizer and BioNTech announced 90% efficacy (at 7 days post the second dose) in their BNT162b2 COVID-19 mRNA vaccine candidate. It is important to remember that these patients are not having their SARS-CoV-2 antibodies titers checked, rather the reported efficacy is based on the development of SARS-CoV-2 post treatment in the placebo and vaccine groups. Also of note is the timing at which this COVID-19 vaccine operates. It is a two dose vaccine separated by approximately 3 weeks, meaning the 90% efficacy reported takes place 28 days after the vaccination process has begun. Thus, once this COVID-19 vaccine begins to roll out, it is not an immediate protection. Pfizer and BioNTech will continue to monitor these patients to see the duration of efficacy for the vaccine.

The Food and Drug Administration (FDA) has been active on COVID-19 therapies with the administration officially giving FDA approval to Remdesivir as a COVID-19 therapy. Also in an interesting turn of events, the FDA has also granted emergency use authorization (EUA) to bamlanivimab (LY-CoV555) which has had a rocky road over the past few weeks. In mid October, Eli Lily halted one of its trials of bamlanivimab, a SARS-CoV-2 specific monoclonal antibody, in hospitalized patients. This decision stemmed from the NIH announcing that bamlanivimab had not demonstrated significant efficacy in hospitalized patients in its own trial. However, Eli Lily and the NIH are both pursuing the treatment in mild and early diagnosed COVID-19 patients in their Blaze and ACTIV-2 trials. Based on Eli Lily’s BLAZE-1 data, they applied for FDA EUA status which was granted only for mild and preemptive treatment after diagnosis. It is very important to note that “Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.” These results are extremely concerning as this potentially suggests that many monoclonal antibodies that are being developed will not be effective in severe COVID-19. Thus, to date Dexamethasone is the only drug that has demonstrated strong efficacy in late stages of severe disease, while most other therapies deemed effective in COVID-19 are being used primarily early in disease course.