Moderna Stock Price, News & Analysis

Moderna (NASDAQ:MRNA) announced that Health Canada has authorized its second bivalent COVID-19 booster vaccine, mRNA-1273.222, which targets the Omicron BA.4/BA.5 subvariants. This authorization follows the earlier approval of mRNA-1273.214 in September 2022. The 50 µg booster dose comprises mRNA for both BA.4/BA.5 and the original SARS-CoV-2 strain. The approval is based on pre-clinical data and ongoing Phase 2/3 trials. This development underscores Moderna's rapid vaccine innovation capabilities to combat emerging COVID-19 variants.

Moderna reported Q3 2022 revenues of $3.4 billion, down from $5.0 billion in Q3 2021, primarily due to declining COVID-19 vaccine sales. The company expects $18-$19 billion in revenue from advance purchase agreements for 2022, with some delivery delays pushing $2-$3 billion to 2023. GAAP net income dropped 69% to $1.0 billion, while diluted EPS fell 67% to $2.53. Moderna completed a $3 billion share repurchase plan and continues to progress in multiple vaccine developments, including RSV and flu candidates.

Moderna, Inc. (NASDAQ: MRNA) announced that its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222, received approval from Japan's Ministry of Health, Labour and Welfare. This booster is designed for adults aged 18 and older and contains mRNA-1273 and a variant-targeting component. The approval aims to provide a stronger immune response against circulating Omicron subvariants in Japan. The Phase 2/3 trial for the vaccine is ongoing, supported by Takeda Pharmaceutical Co. for distribution during Japan's national vaccination campaign.

Moderna (Nasdaq: MRNA) has received a positive opinion from the European Medicines Agency's CHMP recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster for individuals aged 12 and older. This follows the recent approval of the mRNA-1273.214 vaccine targeting Omicron BA.1. The bivalent vaccine mRNA-1273.222 aims to provide protection against Omicron subvariants as winter approaches. Initial data from a Phase 2/3 trial is expected later this year, enhancing Moderna's position in the COVID-19 vaccine market.

Moderna has received a positive opinion from the European Medicines Agency's CHMP to include its COVID-19 vaccine, Spikevax (mRNA-1273), for children aged 6 months to 5 years. This follows positive interim results from the KidCOVE study, which showed robust antibody responses and safety for this age group. The two-dose series, comparable in efficacy to adults, takes one month to complete. The authorization decision by the European Commission is forthcoming, expanding vaccination options for young children, particularly at risk from COVID-19.

Moderna, Inc. (NASDAQ:MRNA) has announced positive clinical results for its bivalent booster, mRNA-1273.214, showing a durable immune response against COVID-19 variants. New data revealed that 90 days post-administration, the booster generated superior neutralizing antibody responses against Omicron BA.1 compared to its previous version. The booster also effectively targets variants BA.4/BA.5 and BA.2.75. Safety profiles remained consistent with earlier doses, with no new safety concerns reported. Comprehensive data will be presented at ID Week on October 20, 2022.

Moderna and Gavi have mutually decided to cancel pending orders for COVID-19 vaccines for 2022. Instead, they will establish a new agreement allowing Gavi to procure up to 100 million doses of updated variant-specific vaccines in 2023 at Moderna's lowest price tier. Moderna has delivered nearly 70 million doses to low- and middle-income countries through Gavi's COVAX initiative, also facilitating over 100 million donations. This agreement aims to ensure equitable access to COVID-19 vaccines for vulnerable populations.