Washington: New Delhi: The global vaccine manufacturer, Moderna, on Tuesday announced that the phase 2/3 study of its Covid-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.
It said that no cases of Covid-19 were observed in participants who had received two doses of the Moderna Covid-19 vaccine using the primary definition.
In addition, a vaccine efficacy of 93 percent in seronegative participants was observed starting 14 days after the first dose using the secondary CDC case definition of Covid-19, which tested for milder disease. As many as 3,700 participants ages 12 to less than 18 years were enrolled in the US in the study called TeenCOVE study.
The company plans to submit these data to regulators globally in early June.
Read:| Pfizer, Moderna refused to sell Covid shots: Kejriwal
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, chief executive officer of Moderna. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic,” he added.
During the study, the participants randomized in 2:1 to two 100 µg doses of mRNA-1273 or placebo. The primary endpoint of non-inferior immunogenicity versus the phase 3 adult study comparator group was met. After two doses, no cases of Covid-19 were observed in the vaccine group using the case definition from the adult phase 3 COVE study, compared to 4 cases in the placebo group, resulting in a vaccine efficacy of 100 percent starting 14 days after the second dose.
“Because the incidence rate of Covid-19 is lower in adolescents, a secondary case definition based on the CDC definition of Covid-19 was also evaluated to include cases presenting with milder symptoms. Using the CDC definition, which requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2 by RT-PCR, a vaccine efficacy of 93 percent after the first dose was observed,” Moderna said in a statement.
It said that mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the phase 3 COVE study in adults.
Read:| Moderna refuses to send vaccines to Punjab, says it only deals with central govt
No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills, it said.
“Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Consequently, these data are subject to change based on ongoing data collection. The company plans to submit data from the TeenCOVE study to a peer-reviewed publication,” the company said.
Read:| US to offer 80 million vaccines to Covid-hit countries
