CX-038839 Omicron (XBB.1.5)

The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair, effective 21 September. CHMP recommended marketing authorisations for eight new medicines, including Elahere, Hetronifly, Hympavzi, Penbraya, Theralugand, Afqlir, Opuviz, and Pomalidomide Teva. It also recommended extending indications for 12 existing medicines and confirmed the refusal of Syfovre's marketing authorisation. Applications for Durysta, Tecentriq, and Sialanar were withdrawn. CHMP updated Spikevax and Comirnaty vaccines to target new COVID-19 variants.

COVID vaccines have saved over 1.4 million lives in WHO's European region. SARS-CoV-2 continues to evolve, affecting immunity. Australia has updated vaccines four times, now considering a fifth targeting JN.1. JN.1 vaccines should protect against newer subvariants like FLiRT and FLuQE. Regulatory bodies like the FDA and TGA are evaluating JN.1 vaccines, with Moderna and Pfizer's Spikevax and Comirnaty under review in Australia. Safety and efficacy data show improved immune responses against newer variants. Novavax, a protein-based vaccine, offers an alternative for those unable to receive mRNA vaccines. Challenges include vaccine uptake and quicker approval processes.

Moderna plans to slow R&D spending, aiming for break-even by 2028 with $6 billion revenue, but analysts doubt it can avoid raising equity. Shares dropped 12% following the announcement, reflecting investor skepticism. The company aims for 10 product approvals by 2027, focusing on respiratory vaccines and diversifying its pipeline. Moderna's R&D spend will reduce from $4.6 billion to $3.8 billion annually by 2026-2028, with cuts impacting various programs, including respiratory, oncology, and cardiovascular.

Moderna announces 10 product approvals by 2027, including next-gen COVID and flu/COVID combo vaccines for 2024 submission, positive Phase 3 results for RSV vaccine for high-risk adults, and norovirus vaccine advancing to Phase 3. The company plans to reduce R&D expense by $1.1 billion and extend financial framework through 2028.

EMA's CHMP recommends Moderna's updated Covid-19 vaccine, Spikevax, targeting JN.1 variant for potential authorisation in 2024-2025. The recommendation is based on comprehensive data, following EMA's ETF guidance. The vaccine has been approved in Taiwan, Japan, and the UK, with ongoing reviews globally. Moderna participates in EU's mRNA vaccine procurement.

Moderna's updated COVID-19 mRNA vaccine, Spikevax, targeting SARS-CoV-2 variant JN.1, received a positive recommendation from the European Medicines Agency's CHMP. The vaccine is intended for individuals aged six months and above, expected for the 2024-2025 vaccination season. Moderna also participates in HERA's tendering procedure for mRNA COVID-19 vaccines.

Moderna is close to securing EU approval for its updated COVID-19 vaccine, Spikevax, targeting the JN.1 variant. The EMA's CHMP recommended authorization, pending European Commission decision for the 2024-2025 season. Moderna's vaccine aims to enhance antibody responses against JN.1 and related lineages for individuals aged six months and older. The company has already secured approvals in Japan, Taiwan, and the UK, with ongoing reviews elsewhere. Moderna participates in the EU's HERA tendering process, potentially expanding vaccine reach. The company's mRNA platform supports rapid development of vaccines and therapeutics.

Moderna's updated COVID-19 mRNA vaccine, Spikevax, targeting the JN.1 variant, receives positive opinion from CHMP for authorization in EU for ages 6 months and over for autumn/winter 2024-2025 season, based on efficacy and safety data. Moderna has similar approvals in Japan, Taiwan, and the UK, and is participating in EU tender for Covid vaccines.

Moderna announced EMA's CHMP adopted a positive opinion recommending marketing authorization for an updated COVID-19 mRNA vaccine Spikevax targeting SARS-CoV-2 variant JN.1, for individuals six months and older. The European Commission will decide on its use for the 2024-2025 autumn/winter season.

Moderna's updated COVID-19 vaccine targeting KP.2 variant of SARS-CoV-2 has been approved by the U.S. FDA for individuals 12 years and above, with EUA granted for those 6 months through 11 years. The vaccine aims to prevent COVID-19 and is expected to be available soon.