Paper and Threads

This week J and J published the full results from Phase 1 and 2a Trials on their SARS-CoV-2 vaccine.  These two types of trials are focused on Safety and ability to stimulate an Immune Response.  In these trials they tested multiple variables:  ages 18-55, ages 65+, low dose and high dose, and 1 versus 2 doses.  The vaccine was safe, with mostly low grade local and systemic symptoms (injection site pain, fatigue, headache, myalgia, rare fever).  Immunologic studies demonstrated a 90% immune response, including neutralizing antibodies against the virus.  In addition there was a T cell immune response.  Both age groups included slightly more than 400 volunteers.  Based on these two trials, J and J developed two Phase 3 clinical trials to assess the efficacy of 1 or 2 low doses of the vaccine.  Complete enrollment in the one dose trial was reported on Dec 17th.  An application to the FDA for an EUA requires that at least 50% of the volunteers must be 2 months beyond their vaccination for an adequate safety evaluation (probably Feb).  The 2 dose Phase 3 trial is still ongoing.  Unfortunately J and J says manufacturing is slow.  Read Below

The virus in the above illustration is a harmless inactivated adenovirus that causes colds. 

The J and J vaccine is similar, but different from the mRNA vaccines by Pfizer and Moderna  The DNA code for synthesizing the SARS-CoV-2 spike protein is introduced into the cells of our body with a harmless adenovirus as the carrier.  There the DNA is a template for synthesis of the spike protein and our immune system responds to the spike proteins by developing antibodies and cellular immunity to SARS-CoV-2  J and J successfully made an ebola vaccine using this technique. Based on the results of the Phase 3 clinical trial it may only require one dose to achieve high levels of immunity and it can be stored in the refrigerator.