Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) announced that it has submitted regulatory applications seeking conditional marketing approval or authorization in Europe and Canada for the use of its COVID-19 vaccine, mRNA-1273, in adolescents (aged 12 to less than 18).
The applications were filed based on promising data from the phase II/III study — TeenCOVE — that evaluated mRNA-1273 in adolescents in the United States. The company will file a similar regulatory application for the adolescents to the FDA soon.
Last month, Moderna announced that the vaccine achieved non-inferior immunogenicity in adolescents in the TeenCOVE study compared to COVE study that evaluated the vaccine in adults. Data from the TeenCOVE study showed an efficacy of 100%, with no cases of COVID-19 after 14 days following administration of the second dose.
Additionally, data from the TeenCOVE study also demonstrated a vaccine efficacy of 93% in seronegative adolescent COVID-19 patients who received one dose of the vaccine.
We remind investors that, the company has initiated rolling submission for a biologics license application (BLA) with the FDA seeking
approval/licensure for use of mRNA-1273 in adults earlier this month. A potential approval to the BLA for mRNA-1273 will allow Moderna to continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering of infection rates
Moderna’s stock has gained 110.1% in the year so far against the
industry's decline of 4%. Image Source: Zacks Investment Research
Meanwhile, the company’s key competitors in the COVID-19 vaccine field,
Pfizer ( PFE Quick Quote PFE - Free Report) and its partner BioNTech ( BNTX Quick Quote BNTX - Free Report) received authorization for emergency/conditional use of their COVID-19 vaccine, BNT162b2, in adolescents in the United States and Europe, last month.
Pfizer’s lead in getting adolescent label for the vaccine is likely to hurt potential sales of Moderna’s vaccine.
Please note that Moderna and Pfizer are both developing their COVID-19 vaccine in additional population groups, such as children from 6 months to less than 12 years of age. The companies are also evaluating the administration of a single booster dose mainly with the aim of protecting against the emerging variants of concern.
Moderna is also 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 company is also developing a refrigerator stable mRNA vaccine candidate for COVID-19, mRNA-1283, in an early-stage study.
Meanwhile, Moderna has signed several agreements with different companies including
Sanofi ( SNY Quick Quote SNY - Free Report) , Catalent and others to provide large scale, commercial fill-finish manufacturing for mRNA-1273.
In a separate press release, the company announced an agreement with global pharma company, Medison Pharma, to commercialize the mRNA-1273 across Central Eastern Europe and Israel.
Moderna currently carries a Zacks Rank #3 (Hold). You can see
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