Moderna Stock Price, News & Analysis

Moderna, Inc. (Nasdaq: MRNA) has received Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine, mRNA-1273, for individuals aged 18 and older. Delivery of approximately 20 million doses to the U.S. government will begin immediately, with 100-125 million doses expected globally in Q1 2021. The vaccine demonstrated a 94.1% efficacy rate in a pivotal Phase 3 trial involving 30,000 participants. Moderna plans to file a Biologics License Application in 2021 to seek full licensure.

Moderna (Nasdaq: MRNA) announced that the European Commission has increased its order for the COVID-19 vaccine mRNA-1273 by 80 million doses, totaling 160 million doses. The initial deliveries are set to begin early 2021, pending regulatory approval from the EMA. The CEO expressed gratitude for this confidence, while Moderna has confirmed supply agreements totaling over 470 million doses across multiple countries. The company is preparing for distribution in case it receives market authorization.

Moderna, Inc. (Nasdaq:MRNA) announced that the FDA’s advisory committee recommended Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate, mRNA-1273. The recommendation received an overwhelming positive vote with 20 in favor and 0 against. The vaccine demonstrated a 94.1% efficacy rate based on a Phase 3 clinical study involving over 30,000 participants. The company is aiding distribution efforts while ensuring that mRNA-1273 can be transported at standard refrigerator temperatures. The FDA will consider this recommendation for its final decision on EUA.

Moderna, Inc. (Nasdaq: MRNA) has reached an agreement with Singapore's Ministry of Health to supply mRNA-1273, its COVID-19 vaccine candidate. The Phase 3 COVE study, which included 30,000 participants, demonstrated an efficacy of 94.1% against COVID-19 and 100% against severe cases. Safety data reveal common reactions like fatigue and headache, primarily after the second dose. Moderna plans to deliver approximately 500 million doses annually, with potential scalability to up to 1 billion doses. The vaccine remains stable at refrigerator temperatures for 30 days.

Moderna, Inc. (Nasdaq: MRNA) announced the U.S. government's option exercise for an additional 100 million doses of its COVID-19 vaccine candidate, mRNA-1273, raising the total to 200 million doses. The company will deliver approximately 20 million doses by December 2020, with the remaining to follow in early 2021. The new order is set for delivery in Q2 2021, pending Emergency Use Authorization (EUA) from the FDA. Moderna continues to strengthen its manufacturing capabilities while working with the U.S. government and global stakeholders to distribute mRNA-1273.

Moderna Inc. (Nasdaq: MRNA) has initiated a Phase 2/3 clinical trial for its COVID-19 vaccine candidate, mRNA-1273, targeting adolescents aged 12 to less than 18. This study, supported by BARDA, aims to enroll 3,000 participants in the U.S. and evaluate safety, reactogenicity, and immunogenicity with two vaccinations 28 days apart. Results are expected in spring 2021 to inform potential use ahead of the school year. The vaccine, co-developed with NIAID, is not yet approved for use.

Moderna (Nasdaq: MRNA) announced a significant increase in its confirmed order from the Canadian government for its COVID-19 vaccine candidate, mRNA-1273. The order has grown by 20 million doses, totaling 40 million doses. Moderna is progressing towards potential delivery as early as December, pending regulatory approval. The efficacy analysis from the Phase 3 COVE study reported a 94.1% vaccine efficacy, with safety monitoring ongoing. The vaccine supply will be sourced from Moderna's European production capabilities, emphasizing its collaboration with various international partners.

Moderna, Inc. (Nasdaq: MRNA) announced an expanded supply agreement with the Israeli Ministry of Health for an additional 4 million doses of its COVID-19 vaccine candidate, mRNA-1273, totaling 6 million doses. This agreement aims to provide early access to the vaccine for Israeli citizens. Moderna has initiated the regulatory review process with Israel's Ministry of Health. The primary efficacy analysis of the Phase 3 COVE Study confirmed a vaccine efficacy of 94.1%, with the company ramping up global manufacturing capabilities to produce up to 1 billion doses annually.

Moderna, Inc. (Nasdaq: MRNA) provided an update on its COVID-19 vaccine candidate, mRNA-1273. Interim data from a NIH-led Phase 1 study showed that participants maintained high levels of neutralizing antibodies for up to 119 days post-first vaccination. The company anticipates producing 20 million doses by the end of 2020 and between 100 million and 125 million doses globally in Q1 2021. mRNA-1273 demonstrated a 94.1% efficacy rate in the Phase 3 study. No serious adverse events were noted, supporting the vaccine's safety profile.