Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine. 

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia. 

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

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CueVac and GSK launch Phase 1 trial of mRNA-based flu vaccine

CureVac (NSDQ:CVAC) and GSK (NYSE:GSK) have announced the dosing of the first participant in a Phase 1 study of a multivalent influenza vaccine built on a second-generation mRNA backbone. The study is based in Panama and will enroll approximately 240 subjects.

CVAC shares increased 2.27% to $19.34 in mid-day trading.

At various points last year, however, the company’s stock was trading over $100 per share on enthusiasm about the company’s first-generation COVID-19 vaccine. However, the shares later tanked after the company announced that interim vaccine efficacy was 47% in the Phase 2b/3 study.

The company’s second-generation COVID-19 vaccine remains in pre-clinical development.

Its influenza vaccine candidate has multiple non-chemically modified mRNA constructs related to four different influenza strains.

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are also developing mRNA-based influenza vaccines.

Investors were dis…

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Intranasal FluGen vaccine offers protection in human challenge study

Madison, Wis.–based FluGen has announced that its Bris2007 M2SR flu vaccine candidate demonstrated protection against a multi-seasonal, seven-year drifted influenza strain in a Phase 2 study.

Some 54% of M2SR vaccine recipients were infected after exposure to a flu strain. Conversely, 71% of placebo recipients were infected, indicating that the vaccine was 24% effective against the strain.

The results, which were published in the Journal of Infectious Diseases, mark the first time a vaccine demonstrated the ability to protect against a highly drifted influenza A (H3N2) flu virus in a human challenge study, according to FluGen.

The study indicates that the vaccine triggers a broad immune response. Conversely, traditional flu vaccines offer strain-specific protection and struggle to protect against the H3N2 strain, which has driven an increasing proportion of flu cases in recent years.

In the challenge study, investigators randomized adults aged 18 …

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