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Moderna Announces Advancements Across Its Pipeline

While issuing a clinical and program update on Thursday, Moderna, Inc. (MRNA) said it continues to advance a range of COVID-19 vaccine options for adults, adolescents, and pediatric populations. With regard to Spikevax commercial outlook, the company said its Advance purchase agreements for 2022 are at approximately $21 billion and options are at approximately $0.5 billon.

"There is an opportunity for Moderna to positively impact public and global health, and with 31 active development programs, 19 of which are in the clinic, we expect to address several critical unmet medical needs with the power of our mRNA platform," said Stéphane Bancel, CEO of Moderna.

Moderna is advancing development of several boosters, including the prototype booster, an Omicron-specific booster and a bivalent booster. The company noted that development is underway for a next-generation refrigerator-stable mRNA COVID-19 vaccine, mRNA-1283.

Moderna will submit a request for authorization of a 25 µg two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the FDA, European Medicines Agency, and other global regulators in the coming weeks. Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age. The company is preparing to evaluate the potential of a booster dose for all pediatric populations.

Moderna is also introducing a program to develop a vaccine candidate, mRNA-1287, against endemic human coronaviruses.

Moderna stated that, in an interim analysis of a phase 2 study of influenza vaccine candidate mRNA-1010, no significant safety concerns were identified, and the immunogenicity data is consistent with a potential for superiority to standard dose vaccine for influenza A strains.

Moderna said it is advancing vaccine candidates against five viruses that cause latent infections, three of which are in clinical trials. In a phase 2 study, the CMV vaccine, mRNA-1647, was observed to be generally well tolerated and interim data shows strong immunogenicity.

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