The CDC now recommends an 8-week interval between the first and second dose of an mRNA COVID-19 vaccine as an option in patients 12 and older, especially males ages 12–39 years to reduce the small risk of myocarditis and increase peak antibody response and vaccine effectiveness.
A CDC analysis of VAERS data, from 21,335,331 patients aged 12–20 years, found the incidence of multisystem inflammatory syndrome in children (MIS-C) to be one case per million individuals receiving one or more doses of a COVID-19 vaccine.
In the 138 patient, Phase IV, CoronavRheum trial (NCT04754698), pausing methotrexate administration for two weeks after each COVID-19 vaccine dose increased IgG seroconversion and neutralizing antibody titers in Brazilian patients with rheumatoid arthritis. The Chinese Sinovac-CoronaVac COVID-19 vaccine was used in the CoronavRheum trial.
A preprint draft describes the New York State Department of Health’s analysis of vaccine effectiveness with two doses of the Pfizer-BioNTech COVID-19 vaccine in children 5 to11 and 12 to 17 years after emergence of the Omicron variant. From December 13, 2021 to January 30, 2022 vaccine effectiveness (VE) in adolescents 12 to 17 years decreased from 66% to 51% and effectiveness against hospitalization decreased from 85% to 73%. In children 5 to 11 years VE decreased from 68% to 12% and against hospitalization from 100% to 48%.
Unlike the New York data, an analysis of data from 10 states by the CDC did not find a rapid decrease in vaccine effectiveness in children 5 to 11 and 12 to 17 years. There was a decrease in VE against the Omicron variant with VE approaching zero at 5 months. Two weeks to ten weeks after the second immunization the CDC found vaccine effectiveness against emergency department or urgent care visits, when Omicron was the predominant variant, to be 76% for adolescents 12 through 15 years, 83% for adolescents 16 to 17 years and 46% for children ages 5 through 11. After 5-months, VE was 38% among adolescents aged 12 to 15 years and 46% among 16 to 17 years. VE increased to 83% in adolescents 16 to 17 years, 7 or more days after a booster dose. Due to the late start of vaccination for the younger age group, data was not available for longer time periods.
In the 101 patient, Phase III, COV-BARRIER trial (NCT04421027), adding baricitinib to standard of care, including corticosteroids, reduced mortality at 28 days (39% vs 58%) and at 60 days (45% vs 62%) compared to placebo in critically ill hospitalized adults with COVID-19 requiring invasive mechanical ventilation or extracorporeal membrane oxygenation.
The FDA limited the EUA for sotrovimab to be used in geographic areas where the disease is likely caused by a susceptible COVID-19 variant.
The FDA increased the initial dose of tixagevimab to 300 mg and cilgavimab to 300 mg, because available data suggests the combination is less active against certain Omicron subvariants. The higher dose may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the original 150mg/150mg dose. Tixagevimab and cilgavimabhave have an EUA for emergency use as pre-exposure prophylaxis (PrEP) for prevention of COVID-19 in patients 12 years of age and older weighing at least 40 kg in patients who may not mount an adequate immune response to COVID-19 vaccination or patients who are allergic or intolerant to a COVID0-19 vaccination.
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