COVID-19 Update #115 for 12/23/2021

COVID-19 Antivirals
 
The FDA granted an emergency use authorization (EUA) for the combination of nirmatrelvir and ritonavir (Paxlovid, Pfizer), on 12/22/21, for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older weighing at least 88 pounds who are at high risk for progression to severe COVID-19. The treatment is dosed as two tablets of nirmatrelvir and one tablet of ritonavir taken together orally twice daily for five days. Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients and Caregivers for additional information. Pfizer will begin shipping nirmatrelvir and ritonavir to the U.S. government immediately and expects to complete delivery of 10 million courses of treatment in 2022.

The FDA granted an emergency use authorization (EUA) for molnupiravir (Lagevrio, Merck), on 12/23/21, for the treatment of mild-to-moderate COVID-19 in patients 18 years of age and older who are at high risk for progression to severe COVID-19 and alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. The treatment is dosed as four tablets twice daily for five days. Molnupiravir is not recommended for use during pregnancy. Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients and Caregivers for additional information. Merck will begin shipping 3.1 million doses of molnupiravir to the U.S. government as soon as a final label is approved by the FDA.
 
In the 29-day, 1,443 patient, Phase II/III, MOVe-OUT trial (NCT04575597), 6.8% of patients treated with a five-day course of molnupiravir were hospitalized or died compared to 9.7% with placebo in unvaccinated outpatients with mild-to-moderate COVID-19 with at least one risk factor to progress to severe disease. An interim analysis from 775 patients had suggested that 7.3% of patients treated with molnupiravir were hospitalized or died compared to 14.1% with placebo.
 
In the 28-day, 562 patient, Phase III, PINETREE trial (NCT04501952), 0.7% of patients treated with a 3-day course of remdesivir were hospitalized or died compared to 5.3% with placebo in nonhospitalized patients with at least one risk factor to progress to severe disease.
 
COVID-19 Vaccines
 
The CDC’s ACIP recommended that COVID-19 vaccines from Pfizer and Moderna should be preferred over the J&J vaccine due to the risk for a rare but potentially fatal thrombosis with thrombocytopenia syndrome with the J&J vaccine.
 
Moderna announced that preliminary lab results found that antibody levels after a booster (third) dose of their COVID-19 vaccine increased antibody levels that are thought to be high enough to neutralize the Omicron variant. A pre-print draft described how antibody levels were not high enough after two doses of the vaccine to neutralize the Omicron variant.
 
In a review of 4, 155, 361 patients that received an mRNA vaccine the rate of myocarditis was estimated to be 1.4 per 100 ,000 patients with the Pfizer-BioNTech COVDI-19 vaccine and 4.2 per 100 ,000 patients with the Moderna vaccine.
 
Sanofi and GSK announced that in a 521 patient, Phase I/II trial (NCT04537208), using their COVID-19 vaccine as a booster dose for vaccines from Pfizer/BioNTech, Moderna, Johnson & Johnson, and AstraZeneca resulted in an increase in neutralizing antibodies of 9- to 43-fold.
 
In the 29,582 patient, Phase III, PREVENT-19 trial (NCT04611802), two immunizations of NVX-CoV2373 (Novavax)ngiven 21-days apart resulted in 90.4% efficacy for developing a COVID-19 infection and 100% efficacy in preventing severe COVID-19.
 
Pfizer and BioNTech announced that in 4,500 patient, Phase I/II/III trial (NCT04816643), two 3 mcg doses of their COVID-19 vaccine given to patients 6 to 24 months old demonstrated immunogenicity similar to that seen with the adult dose in patients 16 to 25 years old. An inadequate response was elicited in patients 2 to under 5 years old with the 3 mcg dose, so a third dose will be evaluated in patients 6 months to under 5 years.
 
COVID-19 Antibodies
 
In a pre-print draft of a 28-day, 1,181 patient, Phase II trial (NCT04373460), 2.9% of patients treated with high titer convalescent plasma were hospitalized for COVID-19 compared to 6.3% with placebo in outpatients with recent onset of COVID-19.