Moderna Inc. announced that it has dosed the first patient in the phase II/III study — KidCOVE — that will evaluate its COVID-19 vaccine, mRNA-1273, in children aged six months to less than 12 years. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

The first part or the phase II portion of the study will determine the suitable dose of the vaccine to be used in the second part or the phase III portion of the study. The first part will evaluate three doses — 25 μg, 50 μg and 100 μg — in children aged six months to less than two years and two doses — 50 μg and 100 μg — in participants aged two years to less than 12 years.

The phase III portion of the study will evaluate the chosen dose of mRNA-1273 for vaccine effectiveness, vaccine safety and reactogenicity as its primary endpoints.

Other Developments

We note that the company is evaluating its COVID-19 vaccine in another phase II/III study — TeenCOVE — in adolescents aged 12-17 years. Meanwhile, the company is already commercializing the vaccine among adults. Per the latest update, 53 million doses of mRNA-1273 have been administered globally. The company expects the vaccine to generate sales of $18 billion in 2021. The company targets to supply 1.4 billion doses of the vaccine in 2022, up from the anticipated 1 billion doses this year.

Moderna’s stock has gained 49.4% in the year so far compared with the industry's growth of 3.3%.

The company is also developing booster vaccine candidates targeting different variants of coronavirus and a next-generation COVID-19 vaccine candidate, mRNA-1283, to facilitate easier distribution and administration.

Booster Study

Earlier this month, the company started dosing patients with its modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, in an ongoing phase II study. Although mRNA-1273 has shown robust neutralizing activity against the U.K. and South African strains of coronavirus, neutralizing titers were reduced six-fold against the South African strain.

Therefore, the company is developing a South African strain-specific booster candidate, mRNA-1273.351, and a multivalent booster candidate, mRNA-1273.211, for protection against the original and South African variant coronavirus. The NIAID will also conduct a parallel study to evaluate these booster candidates.

Next-Generation COVID Vaccine

Moderna initiated a phase I study earlier this week to evaluate three doses — 10 µg, 30 µg, and 100 µg — of its refrigerator stable mRNA vaccine candidate for COVID-19, mRNA-1283. While the study will evaluate two-dose regimens for the lower two doses, it will evaluate a single dose of 100 µg in healthy adults.

Data on these regimens will be compared to data from the COVE study that evaluated mRNA-1273. The next-generation candidate is intended to be used as a booster dose for previously vaccinated or naturally recovered individuals as well as a primary vaccine for seronegative individuals.

Future Prospect

These developments, if successful, will boost prospects of the company, going forward, as the demand for vaccines is likely to continue for a few years. Per a CNBC article, several experts believe that SARS-Cov-2, the virus that causes COVID-19, will become endemic. This means that the virus will be prevalent in different geographical regions, if not the whole world.

Booster doses of COVID-19 vaccines will likely be in demand in this scenario, like flu shots, which generate significant revenues for multiple pharma companies. However, the segment will be competitive with the presence of the already approved vaccines — Pfizer’s BNT162b2, J&J’s COVID-19 vaccine and AstraZeneca’s COVID-19 vaccine — and several others in pipeline, which may receive approval down the line.

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