Moderna (MRNA) Gets EMA Authorization for SpikeVax Third Dose

Moderna, Inc. MRNA announced that the European Medicines Agency (EMA) has authorized the third dose of its mRNA-based COVID-19 vaccine, Spikevax (mRNA-1273), for use in certain immunocompromised individuals aged 12 years or older. The additional dose needs to be administered after at least 28 days from the completion of the initial two-dose regimen.

The immunocompromised individuals include patients with weakened immune systems, such as organ transplant recipients whose initial responses to vaccination were low.

Data from the recent clinical study conducted by the company in 120 participants who had undergone solid organ transplant demonstrated that the third dose of mRNA-1273 improved immune response compared to placebo.

The data from a few clinical studies demonstrated that antibodies in immunized individuals persisted for up to six months. However, health authorities remain on high alert due to the extremely contagious nature of the Delta variant as well as the presence of other COVID-19 variants. Moreover, a comparison study data showed that amid the prevalence of the Delta variant, the effectiveness of both vaccines declined with a more pronounced decrease for BNT162b.

The booster doses of both these vaccines — Pfizer PFE/BioNTech’s BNTX BNT162b and Moderna’s mRNA-1273 — had received authorization in the United States in August for immunocompromised adults.

Moderna’s shares have surged 218% so far this year against the industry’s 10.9% decrease.

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Last month, Moderna submitted a regulatory application to the EMA, seeking conditional marketing approval for the third or booster dose (50 micrograms) of Spikevax for use in all adults. The regulatory application for the booster dose was based on data from an ongoing phase II study.

The company had amended the design of its previous phase II study that evaluated the initial two-dose regimen of mRNA-1273 to include a booster dose of mRNA-1273 at the 50 microgram-dose level to interested participants. The booster or third dose was administered six months after the second dose. Initial data from the study demonstrated that the booster dose boosted neutralizing titers significantly compared with the level achieved in the phase III COVE study. The boost in neutralizing titers was seen across all age groups, notably in the age group of 65 and above (older adults).

Data from an additional analysis showed that the booster dose significantly increased geometric mean titers for all the variants of concern. These titers increased 32-fold for Beta (B.1.351), 43.6-fold for Gamma (P.1), and 42.3-fold for the Delta (B.1.617.2) variant.

Along with Moderna, Pfizer is also seeking authorization/approval for the third dose of its COVID-19 vaccine. J&J JNJ submitted data to the FDA to seek emergency use authorization for the booster dose of its single-shot COVID-19 vaccine earlier this week.

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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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