Company plans to initiate a rolling submission for US Food and Drug Administration (FDA) Biologics License Application (BLA) this month for the vaccine.
Moderna announced its mRNA-1273 COVID-19 vaccine was 96% effective against the virus in a 12-17 year old population. The vaccine was considered generally well tolerated with no serious safety concerns identified to date, according to the company’s initial data analysis from 3235 participants in the phase 2/3 TeenCOVE study.
The TeenCOVE data analysis included 12 cases starting 14 days after first dose and based on the CDC definition of COVID-19, which requires one COVID-19 symptom and paired with a nasopharyngeal swab or saliva sample positive for SARS-CoV-2 by RT-PCR. Because the incidence rate of COVID-19 is lower in adolescents, the case definition is less stringent than for COVE, resulting in vaccine efficacy against milder disease. The median duration for follow-up in this initial analysis was 35 days following the second dose.
No serious safety concerns were witnessed. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose were headache, fatigue, myalgia and chills.
Moderna continues to gather data from the TeenCOVE trial and is in discussions with regulators about a potential amendment to its regulatory filings.
Earlier this week the company, announced it had reached an agreement with Gavi, the Vaccine Alliance, to supply up to 500 million doses to 92 low and middle income countries, at the company’s lowest tiered price.
In addition, the company also released data showing a single 50 µg dose of its mRNA-1273 or mRNA-1273.351 vaccine given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2, B.1.351 (South Africa) and P.1 (Brazil) variants.
Moderna plans to ramp up production to increase the number of doses it wants to manufacture. “Based on these first quarter accomplishments and our current manufacturing scale-up trajectory, we were pleased to again increase our base plan for 2021 to 800 million doses,” Moderna CEO Stéphane Bancel, said. “The Moderna team and our manufacturing partners are working hard to get as close to 1 billion doses in 2021 as we can.”