COVID-19 Update #82 for 5/11/2021

COVID-19 Vaccines
 
The FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The previously announced 2,260 patient, Phase III trial, found 100% efficacy with no cases of COVID-19 in patients 12 to 15 immunized with their COVID-19 vaccine compared to 18 cases in the placebo group. The FDA has updated the Fact Sheets for Healthcare Providers and Patients and Caregivers with information to reflect the use of the vaccine in adolescents.
 
Pfizer and BioNTech are working on a new formulation of their COVID19 vaccine that will be stable at refrigerator temperatures (2 to 8 degrees C) for six months. Moderna has reported a new formulation that is stable for three-months at 2 to 8 degrees C.
 
Moderna announced that preliminary data from a 40-patient trial suggested that booster injection with either the original Moderna COVID-19 vaccine or a new vaccine targeting the B.1.351 (South African) variant increased antibodies against that variant and the P.1 (Brazil) variant. All participants were previously fully vaccinated with Moderna’s vaccine. The new vaccine is designed to elicit antibodies for the B.1.351 variant eliciting higher titers of antibodies for the variant.
 
Moderna announced preliminary data from the Phase II/III TeenCOVE trial (NCT04649151) suggested 96% efficacy in adolescents ages 12 to 17 years. The vaccine was well tolerated with no serious adverse events.
 
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is examining whether the Pfizer-BioNTech COVID-19 vaccine increases the risk for myocarditis. PRAC has also asked Moderna for data. Neither the CDC nor PRAC have found an association for myocarditis with current data.
 
Researchers in Qatar estimated the efficacy of the Pfizer–BioNTech COVID-19 vaccine as 89.5% against the B.1.1.7 (U.K.) variant and 75% for the B.1.351 (South Africa) variant. For severe, critical, or fatal disease due to the B.1.1.7 or B.1.351 variants, efficacy was 97.4%. During data collection, 50% of cases were from the B.1.1.7 variant and 44.5% from the B.1.351 variant.
 
In a 4,387 patient, Phase IIb trial (NCT04533399), where two doses of the Novavax COVID-19 vaccine given 21-days apart resulted in 49.4% efficacy in a South African population. Most cases of COVID-19 were the B.1.351 (South African) variant. The trial population included medically stable, HIV-positive adults. Efficacy was 60.1% among HIV negative patients. 
 
COVID-19 Antibodies
 
Adagio Therapeutics is developing ADG20, a monoclonal antibody directed at a binding site not identified to mutate. ADG20 is being developed in a high concentration solution for intramuscular injection with a long duration of action to prolong immunity.

• Preliminary Phase I data suggests protection with ADG20 for COVID-19 for up to 12 months.
• Adagio is evaluating ADG20 as a treatment for COVID-19 in high-risk mild or moderate COVID-19 patients in the 29-day, 1,728 patient, Phase II/III STAMP trial (NCT04805671).
• Adagio is evaluating ADG20 as a treatment for COVID-19 in high-risk mild or moderate COVID-19 patients in the 6-month, 6,412 patient, Phase III EVADE trial (NCT04859517). The trial will have two cohorts. One using ADG20 as treatment for COVID-19 and the second as prophylaxis in patients at risk for COVID-19 due to household contacts or potential poor response to vaccination.