COVID-19 Update #89 for 6/30/2021

COVID-19 Vaccines
 
The CDC provides advice on myocarditis and pericarditis in adolescents and young adults who received an mRNA COVID-19 vaccine. Most cases have occurred in male patients 16 and older and patients responded well to treatment. The CDC continues to recommend vaccination of all patients 12 years and older due to the greater risk for complications from COVID-19. A preliminary FDA review found reported cases of myocarditis/pericarditis have been consistent with the Pfizer-BioNTech COVID-19 vaccine clinical trials. The reported cases were greater than expected in patients 16 to 24. After the second dose, the incidence is estimated to be 16 cases per million doses. At least 81% of affected patients fully recovered. HHS, CDC and several professional societies published a statement in support of continued vaccination of all eligible patients 12 and older.
 
Oxford University is examining the safety and efficacy of giving two different COVID-19 vaccines to provide evidence for when the use of two different vaccines is unavoidable and to determine optimal use of the vaccines. A preprint draft provides results from the first phase of the 830 patient, Com-COV trial, where the elicited immune response was measured after different combinations of Comirnaty (Pfizer/BioNTech COVID-19 vaccine) and Vaxzevria (AstraZeneca COVID-19 vaccine) were given 4 weeks apart and antibody levels measured 28-days after the second dose.

• The highest antibody titer was obtained from two doses of Comirnaty (14,080 ELU/ml)
• Vaxzevria followed Comirnaty had the second highest antibody titer (12,906 ELU/ml)
• Comirnaty followed by Vaxzevria had the third highest antibody titer (7,133 ELU/ml)
• Two doses of Vaxzevria elicited the lowest antibody titer (1,392 ELU/ml)

T cell responses measured by spot forming cells/1 million peripheral blood mononuclear cells were:

• Vaxzevria / Comirnaty 185 SFC/106 PBMCs
• Comirnaty / Vaxzevria 99 SFC/106 PBMCs
• Comirnaty / Comirnaty 80 SFC/106 PBMCs
• Vaxzevria / Vaxzevria 50 SFC/106 PBMCs

A second phase of Com-COV will examine elicited antibodies with the same combination of vaccines are given 12 weeks apart. 
 
A preprint draft provides results from a study examining antibody levels after a delayed second dose or third dose of the AstraZeneca COVID-19 vaccine. Antibody titers were higher with longer intervals. A third dose of the vaccine produced higher antibody titers and T-cell response.
 
COVID-19 Antibodies
 
HHS and the FDA are pausing distribution of Lilly’s monoclonal antibody combination bamlanivimab and etesevimab and etesevimab alone, due to concerns over resistance with COVID-19 variants. Distribution of bamlanivimab had been paused in April 2021.
 
COVID-19 Anti-inflammatories
 
Emricasan is a pan-caspase inhibitor being developed by Histogen for the treatment of nonalcoholic steatohepatitis. Because of emricasan ability to reduce inflammation, Histogen is evaluating the drug for the treatment of COVID-19. 

• Histogen announced that in a 45-day, 13 patient, Phase I trial (NCT04803227), treatment with emricasan resulted in complete resolution of symptoms by day seven compared to no resolution in the placebo arm in patients with mild symptomatic COVID-19.

 
The FDA granted an EUA for tocilizumab (Actemra, Roche) to treat hospitalized adults and pediatric patients two years of age or older, with COVID-19 and who are receiving a systemic corticosteroid and require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).