COVID-19 Update #121 for 2/16/2022

COVID-19 Antibodies
 
Lilly is developing the monoclonal antibody, bebtelovimab, which preliminary data suggests has activity against the Omicron variant and viruses with mutations to the Omicron variant. Bebtelovimab is being evaluated as a treatment of mild to moderate COVID-19 in high-risk patients.

• The FDA granted bebtelovimab an EUA, on 2/11/2022, for the treatment of mild to moderate COVID-19 in patients 12 years of age and older, who weigh at least 40 kilograms with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19. Fact Sheets are available for health care providers and patients and caregivers for bebtelovimab.
• The FDA provided limited data from the 380 patient, Phase II, BLAZE-4 trial (NCT04634409), where treatment with bebtelovimab reduced the time to sustained symptom resolution compared to placebo in patients at low risk to develop severe COVID-19. Bebtelovimab also reduced the risk for death or hospitalization in 150 high risk patients in a blinded arm of the BLAZE-4 trial and in 176 patients in an open-label arm of the trial. Clinical results were similar rather bebtelovimab was given alone or in combination with other monoclonal antibodies.

COVID-19 Vaccines
 
The FDA postponed the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss dosing of the Pfizer-BioNTech COVID-19 vaccine, in children 6-months to 4 years of age, until data is available on a third dose of the vaccine in young children. Data suggests that a third dose may be needed for children 2 to 5 years old. Data on a third dose is expected to be available in April.
 
In a final analysis of the ENSEMBLE trial, efficacy for the J&J COVID-19 vaccine against moderate to severe–critical COVID-19 was 52.9%, 28 or more days after vaccination. Efficacy was 74.6% to prevent severe–critical COVID-19 
 
Interim results after 29-days from 458 patients enrolled in the NIH sponsored, 12-month, 950 patient, Phase I/II, MixNMatch Study (NCT04889209) examined the results of using a booster dose of the same or a different U.S. authorized COVID-19 vaccine. A booster dose increased antibody titers for all combinations of vaccines received. 
 
A CDC analysis of vaccine effectiveness (VE) data from August 2021 to January 2022 found that VE was higher after the third dose than after the second dose but decreased over time. During the Omicron-predominant period, VE against COVID-19–associated urgent care visits and hospitalizations was 87% and 91%. during the 2 months after a third dose.  VE decreased to 66% and 78% four months after a third dose. Protection was higher against hospitalizations than urgent care visits.