COVID-19 Antibodies and Antivirals
An ICER draft review of drugs that are effective to treat the COVID-19 Omicron variant found the risk for hospitalization or death was reduced by 79% with sotrovimab, 30% with molnupiravir and 88% with Paxlovid. A per protocol analysis of fluvoxamine suggested a 66% reduction in the risk for hospitalization. Due to differences in trial population demographics, ICER did not feel the drugs could be compared based on current evidence. All four drugs were found to be cost effective, with a quality-of-life year gained (QALY) < $100,000. The cost of an averted hospitalization was also < $100,000.
Redhill announced that in a 437 patient, Phase II/III trial (NCT04467840), treatment with opaganib decreased time to viral RNA clearance by at least 4 days compared to placebo in hospitalized patients with severe COVID-19 pneumonia. A subset analysis of 251 patients with an FiO2 of up to 60% found a 62% reduction in mortality. Another subset analysis of 90 patients who were also treated with remdesivir, and corticosteroids found a 70.2% decrease in mortality with the addition of opaganib (6.98% vs 23.4%).
S-217622 is a 3CL protease inhibitor, which blocks replication of SARS-CoV-2. Shionogi is evaluating an oral five-day course of S-217622 for the treatment of COVID-19.
The CDC agreed with the FDA’s full approval of Moderna’s COVID-19 vaccine and recommend it for patients18 years and older.
At the request of the FDA, Pfizer and BioNTech have submitted a request to expand their COVID-19 vaccine EUA to include children 6 months to < 5 years of age. If approved, this age group would receive two 3 mcg doses. Data to support a third dose given 8 weeks after the second dose is expected to be submitted in the next few months. The vaccine has full approval for patients 16 years and older. An EUA covers use in patients 5 to 15 years. The FDA has scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the EUA expansion. In anticipation of approval for the vaccine in the patients 6 months to < 5 years of age, the AMA announced the addition of CPT codes to cover this age group.
In a 77 patient study, 57% of infants, whose mothers were vaccinated maintained COVID-19 antibody titers, at 6-months, compared to 8% of infants whose mothers had recovered from COVID-19.
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