Moderna begins study examining effects of vaccine candidate in adolescents

The company is co-developing it with the National Institute of Allergy and Infectious Diseases, part of the US federal health department.

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020.  (photo credit: REUTERS)
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020.
(photo credit: REUTERS)
One of the leading vaccine developers, Moderna, dosed its first participant on Thursday for its Phase 2/3 study of the mRNA-1273 vaccine designed to treat the novel coronavirus.
The Phase 2/3 study will examine the safety, reactogenicity and immunogenicity of Moderna's vaccine candidate within adolescents aged 12-17.
Moderna intends to enroll 3,000 healthy participants in the study, who will each receive two vaccinations - either a placebo or a 100 μg - administered four weeks (28 days) apart. Following the second dose, participants will be monitored for 12 months to track progress, reinfection, etc.
"We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the US Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," said Moderna CEO Stephane Bancel.
The American biotech firm released early results from its phase 3 clinical trials, announcing in a press release on Monday (US time) that its COVID vaccine has an efficacy of 94.5%, according to an “interim analysis” by an independent data and safety monitoring board.
"We are encouraged by the interim and primary analyses of the Phase 3 COVE study in adults ages 18 and above and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population," he added. "We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting."
Moderna has submitted applications seeking emergency use authorization (EUA) in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective in adults with no serious safety concerns.
Rival Pfizer/BioNTech have also sought EUA after their coronavirus vaccine's two-dose regimen proved 95% effective against COVID-19 and had no major safety issues.
Meanwhile, a panel of outside advisers to the US Food and Drug Administration will meet on Thursday to discuss whether to recommend the use of Pfizer's vaccine for people aged 16 and older.A similar meeting of advisers to the FDA is scheduled for Dec. 17 to discuss Moderna's vaccine.
Among 30,000 phase 3 trial participants, 95 people developed COVID just in the one week after the final vaccination. But encouragingly, 90 of those positive cases occurred in the placebo group, and only five were in the vaccinated group.
Like Pfizer’s vaccine, Moderna’s is an mRNA vaccine.
The company is co-developing it with the National Institute of Allergy and Infectious Diseases, part of the US federal health department.
The practical advantage Moderna appears to have over Pfizer is that its temperature requirements for distribution are simpler: 4℃ rather than -70℃. Storing and transporting a vaccine at 4℃ initially — the temperature of a household fridge — is much easier. By contrast, -70℃ freezers may only be found at major hospitals. For storage beyond 30 days the Moderna vaccine needs to be kept at -20℃, but even -20℃ freezers can be secured more easily.


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