COVID-19 Update #108 for 11/3/2021

COVID-19 Vaccines
 
Pfizer and BioNTech COVID-19 vaccine approved for use in children 5 to 11 years of age.

• Pfizer and BioNTech announced that in a 2,268 patient, Phase II/III trial (NCT04816643), two 10 mcg doses of their COVID-19 vaccine given 21 days apart, to children 5 to 11 years, produced antibody titers comparable to the levels seen with two 30 mcg adult doses in adolescents and young adults age 16 to 25 years. 
• An FDA review of data for the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years, found benefits to outweigh the risks for this age group. Adverse events were similar to adolescents and young adults ages 16 to 25 years. Based on limited follow-up, vaccine effectiveness was estimated to be 90.7% with no cases of severe COVID-19. 
• The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0 with one member abstaining to recommend the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age.
• The FDA agreed with VRBPAC and expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include children 5 to 11 years of age. The pediatric dose is two 10 mcg doses given 21-days apart. 
• While children seem to be less affected by COVID-19 than adults, there has been 8,300 hospitalizations for COVID-19 in children ages 5 to 11 and 146 children have died. In the same age group, 2,316 children have developed multisystem inflammatory syndrome in children (MIS-C) from COVID-19 and nine have died. The mortality rate with COVID-19 in pediatric patients is much higher than influenza. The CDC noted a five-fold increase in pediatric COVID-19 cases attributed the Delta variant this summer.
• The CDC’s ACIP voted 14 to 0 to recommend use of Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age.
• The CDC agreed with ACIP and endorsed use of the Pfizer and BioNTech COVID-19 vaccine in children 5 to 11 years of age. ​
  

Moderna announced the FDA is delaying a decision on use its COVID-19 vaccine in adolescents, 12 to 17 years of age, to allow more time to examine international data on the occurrence of myocarditis. The adolescent dose is the same as the adult dose, two doses of 100 mcg given 28-days apart.
 
Researchers analyzed historical and current data from Olmsted County, Minnesota and found the incidence of cerebral venous sinus thrombosis (CVST) had increased in females who received the J&J COVID-19 vaccine. The highest incidence of CVST was in women 40-49, followed by women aged 30 to 39 years.
 
CDC analysts compared the outcomes of 20,101 fully vaccinated immunocompromised adults to 69,116 fully vaccinated immunocompetent adults and found vaccine effectiveness to prevent COVID-19 related hospitalizations to be 77% for immunocompromised adults compared to 90% for immunocompetent adults. This decrease in effectiveness was present regardless of the type of vaccine used, patient’s geographic location, prevalence of the Delta variant or underlying cause for the immunocompromised state.