Moderna Provides Clinical and Supply Updates on COVID-19 Vaccine Program Ahead of 2nd Annual Vaccines Day
Moderna, Inc., the biotechnology company spearheading mRNA therapeutics and vaccines that have delivered an estimated 132 million doses of its COVID-19 Vaccine globally, has announced clinical and supply updates on its program.
“The Moderna team continues to make important progress with our COVID-19 Vaccine. We are looking forward to having the clinical data from our variant-specific booster candidates, as well as clinical data from the Phase 2/3 study of our COVID-19 Vaccine in adolescents,” the company’s CEO, Stéphane Bancel, said. “The new preclinical data on our variant-specific vaccine candidates give us confidence that we can proactively address emerging variants. Moderna will make as many updates to our COVID-19 vaccine as necessary until the pandemic is under control.”
Update on the Phase 3 COVE Study of the Moderna COVID-19 Vaccine
The Phase 3 COVE study of the Moderna COVID-19 Vaccine (mRNA-1273) identified over 900 COVID-19 cases, including over 100 severe cases, with a median follow-up of about 6 months following the second dose. Vaccine efficacy beginning post-dose 2 exceeds 90% against all COVID-19 cases as well as 95% against severe cases and is consistent with prior updates. The Moderna COVID-19 Vaccine has been offered to all placebo participants, of
which 98% have received it. Moderna will continue to provide updated results from the ongoing COVE study, including
efficacy against asymptomatic infection, genotyping data, additional antibody persistence data, and information concerning potential correlates of protection.
An approximate 3,000 adolescents aged 12-17 in the U.S. are enrolled in the Phase 2/3 TeenCOVE study of mRNA-1273 at the 100µg dose level, and the Phase 2/3 KidCOVE study of mRNA-1273 expects to enroll 6,750 healthy pediatric participants (6 months-11 years) into its two-part, dose-escalation study.
Antibody Persistence Data out to 6 Months Published in The New England Journal of Medicine. In this evaluation of 33 healthy adult participants in the Phase 1 study of Moderna’s COVID-19 Vaccine, three distinct serologic tests detected that antibodies elicited by the vaccine persisted through 6 months following dose 2. Antibody decay, estimated using two approaches, was consistent with published observations of convalescent COVID-19 patients through 8 months of symptom onset.
Preclinical Data on variant-specific Booster Candidates
The Company’s variant-specific vaccine candidates include mRNA-1273.351, targeted against the variant termed B.1.351 first observed in the Republic of South Africa, and mRNA-1273.211, a multivalent booster candidate that combines mRNA-1273 and mRNA-1273.351 within a single vaccine.
Both candidates increase neutralizing titers against SARS-CoV-2 variants of concern in Balb/c mice. The multivalent candidate provided the broadest level of immunity, and an mRNA-1273.351 boost at 6 months closed the neutralizing titer gap for variants of concern, following which neutralizing titers were comparable between the ancestral strain (Wuhan) and the new B.1.351 variant, confirming improved neutralizing titers. Moderna’s Phase 2 a study assessing three approaches to boosting is ongoing.
Global Supply Update
The Company delivered approximately 17 million doses in the fourth quarter of 2020 and approximately 88 million doses in the first quarter of 2021 to the U.S. government, along with approximately 14 million doses to other customers in the latter. Approximately 132a million doses have totally been delivered globally as of April 12, 2021, with approximately 117 million doses to the U.S. government and approximately 15 million doses delivered from
Moderna’s ex-U.S. supply chain; a second 100 million doses followed by an additional 100 a million doses are to be delivered to the U.S. government by May and July 2021 respectively.
Cerebral Venous Sinus Thrombosis (CVST) or Thrombotic Events
Moderna issued a statement based on all available safety data for mRNA-1273 after over 64.5 million doses administered globally, noting no association with CVST or thrombotic events. A replay of the webcast from Moderna’s Vaccine Day (April 14 th ) has been archived on its website for one year following the presentation.
(Source: Moderna, 2021)