COVID-19 Update #132 5/25/2022

COVID-19 Vaccines
 
On 5/17/2022 the FDA approved a booster dose for children 5 to 11 with the Pfizer-BioNTech COVID-19 vaccine. The CDC updated their COVID-19 vaccine recommendations to include a booster for this age group five months after the primary series. The CDC also recommends a second booster (fourth vaccination) for immunocompromised patients 12 and older and everyone older than 50, at least four months after their first booster (third vaccination).
 
In a review of VAERS data, the CDC found no increase in the occurrence of myocarditis with the Pfizer-BioNTech COVID-19 vaccine in males 5 to 11.
 
Pfizer-BioNTech announced that in a 1,678 patient, Phase II/III trial, vaccine efficacy after three 3mcg doses of their COVID-19 vaccine in children six months to five years was 80.3%. Antibody titers were similar in young children as in patients 16 to 25 years. The third dose was given two months after the second and the trial was done when Omicron was the dominant variant.
 
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 6/14/2022 to discuss use of the Moderna COVID-19 vaccine in patients 6 years through 17 years of age. On June 15 VRBPAC will discuss use of the Pfizer-BioNTech COVID-19 vaccine in patients 6 months through 4 years of age.
 
COVID-19 Antivirals
 
In the WHO sponsored, open-label 8,275 patient, Phase III SOLIDARITY trial (NCT04315948), treatment with remdesivir did not improve mortality compared to placebo in the hospitalized patients with COVID-19. There was no statistical difference in mortality in patients who already required ventilation but mortality was lower in patients not on a ventilator (11.9% vs. 13.5%). Among patients not requiring mechanical ventilation at treatment initiation, fewer remdesivir patients progressed to a ventilator than those who received placebo (14.1% vs 15.7%).
 
COVID-19 Anti-inflammatories
 
Clazakizumab, is an interleukin-6 (IL-6) inhibitor being evaluated by CSL Behring as a treatment for hospitalized patients with severe or critical COVID-19 disease accompanied by hyperinflammation.

• In a 28-day, 152 patient, Phase II trial (NCT04343989), treatment with clazakizumab increased the odds of ventilator-free survival and overall survival compared to placebo in patients with severe COVID-19 disease and hyperinflammation.