COVID-19 Update #131 5/18/2022

ICER provided a review of drugs for outpatient treatment of COVID-19. ICER found that compared to symptomatic treatment:

1. Nirmatrelvir/ritonavir (Paxlovid) - evidence was adequate to support a health benefit (13-0 to support a benefit).
2. Molnupiravir - evidence was inadequate to support a health benefit (11-2 for no benefit).
3. Fluvoxamine - evidence was inadequate to support a health benefit, but the vote was 7-6 in favor of a benefit. However, NIH has determined there is not enough evidence to recommend for or against the use of fluvoxamine to treat COVID-19.​ The FDA also did not find sufficient evidence to support use of the drug to treat COVID-19.

Due to differences in trial population demographics, ICER did not feel the drugs could be compared based on current evidence. 
 
All three 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.

1. Paxlovid was found to have high long-term value.
2. Molnupiravir, was found to low-to-intermediate long-term value.
3. Fluvoxamine was found to have intermediate-to-high long-term value.

COVID-19 Vaccines
 
In the 4,016 patient, Phase II/III KidCOVE trial (NCT04796896), two 50 mcg doses of Moderna’s COVID-19 vaccine, given 28-days apart, elicited immunogenicity in children 6 to under 12 years of age that was similar to young adults, age18 to 25 years, who received two 10 mcg doses. Vaccine efficacy was estimated to be 88% during a period when the delta variant was dominant.
 
A CDC test-negative, case-control study, using data from December 2021 to February 2022, estimated the Pfizer-BioNTech COVID-19 vaccine effectiveness against symptomatic infection for children 5 to 11 years as 60% one month after the second vaccine dose and 29% after two months. Vaccine effectiveness for adolescents 12 to 15 years of age was 60% one month after the second dose and 17% after two months. Vaccine effectiveness for adolescents who received a booster dose was 71%.
 
The FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include a single booster dose, at least five months after completion of a primary series, for children 5 to 11 years. Only the Pfizer-BioNTech vaccine is approved for use in this age group. 
 
COVID-19 Antivirals
 
Based on the review of available scientific evidence the FDA declined to approve an emergency use authorization (EUA) for fluvoxamine for the treatment of COVID-19 because the data was insufficient to support use of the drug in the treatment for COVID-19.
 
NIH has provided a reference page to describe drug interactions and their management for Paxvolid (ritonavir-boosted nirmatrelvir).