Moderna - MRNA STOCK NEWS

Moderna, Inc. (NASDAQ:MRNA) has received provisional approval from Australia's Therapeutic Goods Administration (TGA) for its mRNA COVID-19 vaccine, Spikevax, for children aged 6 months to five years. This approval allows vaccination in a previously ineligible age group, enhancing public health measures against COVID-19. The decision follows positive interim results from the Phase 2/3 KidCOVE study, showing robust neutralizing antibody responses and favorable safety profiles. Moderna aims to collaborate with the Australian government for effective implementation of the vaccination program.

Moderna, Inc. (NASDAQ:MRNA) announced that Health Canada has approved the use of its mRNA COVID-19 vaccine, SPIKEVAX, for children aged 6 months to 5 years. This two-dose series, with each dose at 25 µg, is completed over one month, similar to adults' vaccination schedules. Positive interim results from the KidCOVE study indicated that antibody responses in young children were comparable to adults, demonstrating effective vaccine safety and efficacy against the Omicron variant. This marks a crucial step in vaccinating a previously unprotected age group.

Moderna (NASDAQ:MRNA) announced a live conference call on August 3, 2022, at 8:00 a.m. ET to discuss its second quarter 2022 financial results and provide a corporate update. Investors can access the call via telephone or webcast through the company's website. This event will include insights into Moderna's ongoing advancements in mRNA therapeutics and the development of vaccines against infectious diseases, including COVID-19. An archived version of the call will be available shortly after its conclusion.

Moderna has initiated a Phase 1 trial for its mRNA vaccine candidate, mRNA-1215, targeting the Nipah virus, a deadly pathogen with pandemic potential. This trial, conducted in collaboration with the National Institute of Allergy and Infectious Diseases, will assess the vaccine's safety and immunogenicity in healthy adults. Nipah virus has a high mortality rate of 40%-75% and poses significant health risks globally, prompting urgency in vaccine development. Moderna aims to advance 15 vaccine programs by 2025, with mRNA-1215 being a key component of this commitment.

Moderna's mRNA-1273.214 has shown significantly higher antibody responses against various COVID-19 variants, including Omicron subvariants BA.4 and BA.5, versus the current booster. The company has completed regulatory submissions in the EU, UK, and Australia, with more filings expected shortly. Additionally, Moderna is developing another bivalent candidate, mRNA-1273.222, following FDA guidance. Data indicates a geometric mean ratio of 1.69 for neutralizing titers and a 6.3-fold increase in BA.4/5 responses.

Moderna, Inc. (NASDAQ:MRNA) announced promising results from its Phase 2/3 study on the bivalent COVID booster candidate, mRNA-1273.214. This booster demonstrated a greater than 5-fold increase in neutralizing antibodies against the Omicron subvariants BA.4 and BA.5 one month post-administration, showing a neutralizing GMT of 941 for all participants. The company plans to submit this data to regulators and prepare for supply in August, anticipating a rise in infections. The bivalent vaccine is considered essential for addressing the evolving SARS-CoV-2 variants.

Moderna has announced a collaboration with the UK government to establish an mRNA Innovation and Technology Center. This facility aims to enhance access to domestically manufactured vaccines targeting respiratory viruses, including COVID-19 and seasonal influenza. Moderna plans to increase its R&D investments in the UK, supporting rapid pandemic responses as part of the UK’s '100 Days Mission'. A recent purchase agreement was made for 60 million doses of Moderna’s COVID-19 vaccine for delivery over 2022 and 2023.

Moderna, Inc. has received emergency use authorization (EUA) from the FDA for its COVID-19 vaccine mRNA-1273 for children aged 6 months to 17 years. This vaccine is administered in two doses tailored for specific age groups, initiating protection as children return to school. The safety and efficacy data from clinical trials involving over 14,000 children show significant antibody responses and comparable efficacy to adults. The vaccine will be available at select sites, allowing millions of children to receive protection against COVID-19.

Moderna has announced promising clinical data for its COVID-19 booster candidate, mRNA-1273.214, demonstrating an 8-fold increase in neutralizing geometric mean titers against the Omicron variant compared to the original vaccine. The study met all primary endpoints, confirming superior antibody response and safety profiles comparable to the original mRNA-1273. A regulatory submission is planned in the coming weeks to enable its use as a Fall booster. Moderna anticipates more durable protection against variants with this new bivalent candidate, marking a significant advancement in the fight against COVID-19.