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Moderna vaccine shows 100% efficacy in teens

pharmafile | May 26, 2021 | News story | Research and Development  

Moderna’s TeenCOVE study, involving 3,700 adolescents aged 12 to less than 18 years old, observed no cases of COVID-19 after two doses of the vaccine.

This is consistent with a vaccine efficacy of 100%.

The primary endpoint of non-inferior immunogenicity versus the Phase III study adult comparator group was met.

mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase III COVE study in adults, and no significant safety concerns were identified.

In addition, a vaccine efficacy of 93% 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.

Moderna plans to submit these data to regulators globally in early June.

Stéphane Bancel, Chief Executive Officer of Moderna: “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.”

“We will submit these results to the US FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”

All participants from the study 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.

Lilly Subbotin

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