Moderna Submits COVID-19 Vaccine Booster Data for FDA Review
A single 50µg dose of mRNA-1273 given as a booster increased neutralizing antibody titer responses above the phase 3 benchmark.
A single 50µg dose of mRNA-1273 given as a booster increased neutralizing antibody titer responses above the phase 3 benchmark.
Routine annual vaccination is recommended for all patients 6 months of age and older who have no contraindications.
The recall was initiated because the product had prolonged exposure to extremely cold weather during shipment.
The CDC also issued a health advisory about the urgent need to increase COVID-19 vaccination coverage.
The update was based on data from the COV-BARRIER study.
The vaccine contains capsular polysaccharide conjugates for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease.
The TeenCOVE study (ClinicalTrials.gov: NCT04649151) included over 3700 US adolescents aged 12 to less than 18 years.
The safety of the vaccine in this patient population was based on data from 2260 adolescent participants.
Based on the available information, the panel was unable to decide on next steps for the Janssen COVID-19 vaccine.
AZD1222 utilizes a replication-deficient chimpanzee adenovirus to deliver a SARS-CoV-2 protein to induce a protective immune response.