COVID-19 Update #125 3/24/2022

COVID-19 Anti-inflammatories
 
Synairgen announced that NIAID had discontinued the Phase II/III ACTIV-2 COVID-19 trial (NCT04518410) in March 2022, due to changes in the pandemic that necessitate a change in how COVID-19 therapies are evaluated. ACTIV-2 was evaluating several drugs in the treatment of COVID-19.
 
Eiger BioPharmaceuticals announced that in the 28-day, 4,669 patient, Phase III TOGETHER trial (NCT04727424), 2.7% of patients treated with peginterferon lambda were hospitalized or had an ER visit compared to 5.6% with placebo in non-hospitalized adult Brazilian patients with COVID-19, who were at high risk of progressing to severe illness.
 
COVID-19 Vaccines
 
The Vaccines and Related Biological Products Advisory Committee (VRBPAC), CDC and NIH will meet on 4/6/2022 to discuss additional COVID-19 vaccine boosters and how to select specific SARS-CoV-2 virus strains for COVID-19 vaccines to address current and emerging variants.

• Pfizer and BioNTech have requested approval of a fourth dose of their COVID-19 vaccine for adults 65 and older, due to diminished protection over time against the omicron variant.
  • Pfizer and BioNTech are evaluating an Omicron specific COVID-19 vaccine in a 1,420 patient trial as a second booster (fourth dose), first booster (third dose) or as the primary vaccine in unvaccinated patients.
• Moderna requested approval of a fourth dose of their COVID-19 vaccine for adults 18 and older, due to recent data following the emergence of the omicron variant.
  • Moderna is evaluating an Omicron specific COVID-19 vaccine in a Phase II trial in the U.S. and a Phase III trial in England.
• An Israeli study involving 1,050 healthcare workers, who had received a Pfizer/BioNTech or Moderna COVID-19 booster dose at least four months earlier, found an increase in the immune response with a fourth dose against the omicron variant. However, vaccine efficacy was only 30% for any severity of COVID-19 with most cases being mild.
• An analysis of data from 1,138,681 Israeli patients, who were 60 and older, found a lower rate of infection after a fourth dose of the Pfizer/BioNTech COVID-19 vaccine.
• A CDC analysis found that mRNA COVID-19 vaccine effectiveness for the Omicron variant, two months after a booster dose, was 87% to prevent emergency room/urgent care visits (ED/UC) and 91% to prevent hospitalizations. Four months after the booster dose vaccine, effectiveness was 66% to prevent ED/UC and 91% to prevent hospitalizations. A separate study found that mRNA vaccines are 94% effective, after three doses, to prevent invasive mechanical ventilation from severe COVID-19 caused by the Omicron variant.
• An academic analysis of mRNA COVID-19 vaccine effectiveness to prevent hospitalizations, for several SARS-CoV-2 variants, found vaccine effectiveness to be 65% after two immunizations and 85% after three for Omicron. Severity was lower when comparing Delta to Omicron infections. Patients who were vaccinated also had less severe disease for all variants.​
  

Moderna announced interim results from the 11,700 patient, Phase II/III KidCOVE trial (NCT04796896), where vaccine effectiveness for two 25 mcg doses of their COVID-19 vaccine demonstrate immunogenicity similar to young adults (18 to 25 years) in children 6 months to less than 6 years old. Vaccine effectiveness to prevent infections from Omicron was 43.7% in children 6 months to 2 years and 37.5% in children 2 to under 6 years. Most cases of COVID-19 were mild, and no severe disease developed in either age group.
 
Based on previously announced data in older children from the 11,700 patient, Phase II/III KidCOVE trial(NCT04796896), Moderna is requesting approval for use of its COVID-19 vaccine in children 6 to 17 years old.