Aridis Pharmaceuticals Inc. is one of two companies posting COVID-19 data just days before Christmas. Its fully human monoclonal antibody cocktail, AR-701, was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. Moderna Inc. also posted new data that showed preliminary neutralizing data against Omicron following 50-mg doses of its vaccine, which is currently authorized, and 100-mg dose boosters, which increased neutralizing antibody levels 83-fold from the pre-boost levels.
An ongoing evaluation of heart muscle inflammation risk, a key concern with mRNA COVID-19 vaccines globally, could delay through January 2022 completion of an FDA review of Moderna Inc.'s vaccine in adolescents 12 to 17 years of age. The side effect, called myocarditis, has been a particular concern with regulators, especially for adolescents and young men.
Interim data from a phase II/III study of Moderna Inc.’s COVID-19 vaccine show a robust antibody response in children ages 6 through 11, stronger than the one the company found in adolescents. Two 50-mcg doses given 28 days apart also produced a favorable safety profile that nearly mirrored that of adolescents and adults.
Continuing an upward trajectory, BioWorld’s Drug Developers Index (BDDI) has climbed more than 10% since the start of this year, following sharp drops at the end of March and May. Shares began to rebound in June and the index has shown a steady incline, similar with the Nasdaq Biotechnology Index, which is currently up 12%.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
With Monday's announcement that the U.S. FDA has expanded emergency use authorization for Pfizer and BioNtech's COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, and the EMA expected to follow suit in short order, the COVID vaccination campaign is expanding its age range.
Amid what Moderna Inc. called "overwhelming" demand from global governments for mRNA vaccines and boosters with efficacy against SARS-CoV-2 variants of concern, the company said both its authorized vaccine, mRNA-1273, and a strain-matched candidate, mRNA-1273.351, increased neutralizing titers against the variants.
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.
As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission.
A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA."