A revised (3/28/2022) ICER review of drugs that are effective to treat the COVID-19 Omicron variant found that compared to no active treatment:
The CDC found that sotrovimab is not active against the BA.2 Omicron subvariant. NIH (ASPR) will stop distributing sotrovimab in stares and territories where BA.2 has reached 50% frequency. This includes HHS Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) and Region 2 (New Jersey, New York, Puerto Rico, and the Virgin Islands).
A Canadian retrospective analysis of 97,590 pregnant patients and a retrospective study of 157,521 singleton births in Sweden and Norway found that COVID-19 vaccination during pregnancy did not increase the risk of adverse peripartum outcomes compared with vaccination after pregnancy and with no vaccination. Most patients received an mRNA vaccine during the second and third trimester in both studies.
On 3/29/2022, the FDA approved a 4th dose (2nd booster) of mRNA #COVID-19 vaccines for patients 50 and older. In cetain immunocompromised patients the age is lowered to12 and older with the Pfizer-BioNTech vaccine and 18 and older with the Moderna vaccine. This decision was made before a scheduled meeting to discuss vaccine boosters. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), CDC and NIH will meet on 4/6/2022 to discuss additional COVID-19 vaccine boosters and how to select specific SARS-CoV-2 virus strains for COVID-19 vaccines to address current and emerging variants.
Synairgen announced that NIAID had discontinued the Phase II/III ACTIV-2 COVID-19 trial (NCT04518410) in March 2022, due to changes in the pandemic that necessitate a change in how COVID-19 therapies are evaluated. ACTIV-2 was evaluating several drugs in the treatment of COVID-19.
Eiger BioPharmaceuticals announced that in the 28-day, 4,669 patient, Phase III TOGETHER trial (NCT04727424), 2.7% of patients treated with peginterferon lambda were hospitalized or had an ER visit compared to 5.6% with placebo in non-hospitalized adult Brazilian patients with COVID-19, who were at high risk of progressing to severe illness.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC), CDC and NIH will meet on 4/6/2022 to discuss additional COVID-19 vaccine boosters and how to select specific SARS-CoV-2 virus strains for COVID-19 vaccines to address current and emerging variants.
Based on previously announced data in older children from the 11,700 patient, Phase II/III KidCOVE trial(NCT04796896), Moderna is requesting approval for use of its COVID-19 vaccine in children 6 to 17 years old.
We’d like to thank Emily Stock, TJ Lawall and Randy Haley who helped to update the open-access Prescribe Right COVID-19 web pages as part of their Capstone Project at the University of Health Sciences and Pharmacy in St Louis. Due to the hard work of these talented students, the pages are easier to navigate and contain quick-review summary tables.
In a retrospective analysis or data for 1,164 patients, who had been hospitalized for COVID-19 and received less than 10 days of dexamethasone, continuation of dexamethasone after discharge did not reduce mortality or readmission compared to discontinuing dexamethasone at discharge.
An analysis of COVID-19 antibodies in breast milk of vaccinated mothers found that 96% of lactating women who received the Pfizer-BioNTech vaccine and 97% of mothers that received the Moderna vaccine had detectable IgA antibodies in their milk compared to 39% who received the AstraZeneca vaccine and 48% who received the Johnson & Johnson vaccine.
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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