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Moderna's (MRNA) COVID-19 Vaccine 100% Effective in Teens

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Moderna Inc. (MRNA - Free Report) announced that its COVID-19 vaccine, mRNA-1273 met the primary endpoint of immunogenicity in the phase II/III study — TeenCOVE — evaluating it in adolescents (aged 12 to less than 18 years). The primary endpoint was non-inferior immunogenicity 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.

Positive data from the TeenCOVE study demonstrates successful bridging of immune responses to the adult vaccination. Moderna plans to submit data from the study to regulators globally in early June and request authorization for the vaccine. The study has evaluated mRNA-1273 in 3,732 adolescent participants.

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.

Meanwhile, the company’s key competitors in the COVID-19 vaccine field, Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) have already received Emergency Use Authorization for the use of their COVID-19 vaccine, BNT162b2, in adolescents earlier this month. BNT162b2 also demonstrated 100% vaccine efficacy in the adolescent patient population. Pfizer is also looking to get Conditional Marketing Authorization in Europe for this patient population.

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’s stock has gained 62% in the year so far against the industry's decline of 4.9%.

Apart from a booster dose of mRNA-1273, 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 National Institute of Allergy and Infectious Diseases (NIAID) will also conduct a parallel study to evaluate these booster candidates.

Meanwhile, Moderna has also initiated a phase I study 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.

Although Pfizer currently seems to lead the vaccine race, successful developments of Moderna’s COVID-19 vaccine pipeline 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.

Meanwhile, Moderna has signed several agreements with different companies including Sanofi, Catalent (CTLT - Free Report) and Samsung Biologics to provide large scale, commercial fill-finish manufacturing for mRNA-1273.

Zacks Rank

Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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