CX-038839 Omicron (XBB.1.5)
- Generic Name
- CX-038839 Omicron (XBB.1.5)
- Brand Names
- Spikevax
- Drug Type
- Biotech
- CAS Number
- 2918977-08-7
- Unique Ingredient Identifier
- 4F9QRS7ZV2
FDA Expands Warning for mRNA COVID-19 Vaccines Due to Heart Side Effect Risk in Young Males
• The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses.
• New warnings cite data from the FDA's safety surveillance system and a 2023 study showing that while clinical courses were generally mild, myocardial injury was common among affected individuals.
• Health officials maintain that these heart conditions remain rare complications, with CDC data indicating they typically resolve quickly, though studies are ongoing to determine potential long-term effects.
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
• The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010.
• Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
FDA Delays Moderna's Combination Flu-COVID Vaccine Amid Increased Regulatory Scrutiny
• Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.
• The regulatory setback comes amid growing concerns about anti-vaccine sentiment within government, with some states introducing legislation to restrict or ban mRNA-based vaccines despite their established safety profile.
• If eventually approved, Moderna's mRNA-1083 would be the first vaccine in the US to offer protection against both flu and COVID-19 in a single shot, potentially improving vaccination rates through increased convenience.
Moderna and Pfizer/BioNTech Locked in Escalating mRNA Patent Battle with Billions at Stake
• Moderna has filed patent infringement lawsuits against Pfizer/BioNTech in multiple countries, claiming their Comirnaty vaccine infringes on mRNA technology patents that Moderna pioneered and invested billions in developing.
• The legal battle has expanded globally with Moderna scoring a recent victory in Germany, while simultaneously suffering defeats at the USPTO's Patent Trial and Appeal Board where some of its patents were found unpatentable.
• With combined COVID-19 vaccine sales exceeding $100 billion, the financial stakes are enormous, as evidenced by significant settlements already reached with NIH—$400 million from Moderna and $791.5 million from BioNTech.
First Self-Amplifying mRNA COVID-19 Vaccine KOSTAIVE Receives European Commission Approval
• CSL and Arcturus Therapeutics achieve a breakthrough as KOSTAIVE becomes the first self-amplifying mRNA COVID-19 vaccine approved by the European Commission for adults 18 and older.
• Clinical trials demonstrated KOSTAIVE's superior immunogenicity and antibody persistence lasting up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines.
• The vaccine's innovative sa-mRNA technology enables enhanced immune response by instructing cells to produce additional mRNA and proteins, representing a significant advancement in vaccine development.
EU Expands COVID-19 Vaccine Options: New Protein-Based Vaccines Join mRNA Offerings for 2024
• The European Commission and 15 EU countries have initiated a joint procurement for protein-based COVID-19 vaccines, providing alternatives to mRNA vaccines for the 2024 vaccination campaigns.
• Four COVID-19 vaccines are currently authorized in the EU: two mRNA-based (Comirnaty and Spikevax) and two protein-based (Nuvaxovid and Bimervax), with adapted versions targeting newer variants.
• The European Medicines Agency has approved multiple adapted vaccines for autumn 2024, including Comirnaty JN.1, Spikevax JN.1, and Nuvaxovid JN.1, with Bimervax JN.1 under current assessment.
FDA Approves Updated COVID-19 Vaccines Targeting KP.2 Variant for 2024-25 Season
The FDA has approved new formulations of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines specifically targeting the Omicron KP.2 variant. The updated mRNA vaccines are approved for individuals 12 and older, with emergency use authorization granted for ages 6 months to 11 years, marking a shift toward annual COVID-19 vaccine updates similar to influenza vaccines.
Moderna Reports $3.2 Billion in 2024 Revenue, Submits Three mRNA Products for Regulatory Approval
• Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market.
• The company has submitted three investigational mRNA products for regulatory approval, including a next-generation COVID vaccine, RSV vaccine for high-risk adults 18-59, and a flu/COVID combination vaccine.
• For 2025, Moderna projects revenue between $1.5-2.5 billion and plans to reduce costs by nearly $1 billion, with an expected year-end cash balance of approximately $6 billion.
FDA Approves Moderna's mResvia RSV Vaccine for Older Adults
• The FDA has approved Moderna's mResvia (mRNA-1345), an mRNA vaccine, for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and over.
• mResvia demonstrated 78.7% efficacy against RSV with two or more symptoms at 3.7 months, decreasing to 62.5% at 8.6 months follow-up in clinical trials.
• The CDC's ACIP recommended mResvia for adults 75 and older and those aged 60-74 at increased risk of severe RSV, with ongoing trials evaluating other age groups.
• mResvia enters a competitive market with GSK's Arexvy and Pfizer's Abrysvo, potentially differentiating itself through convenient administration and a lack of reported Guillain-Barré syndrome cases.
Moderna Faces Investor Concerns Despite Pipeline Progress and Cost-Cutting Efforts
• Moderna's stock has significantly dropped in 2024 due to waning COVID-19 vaccine demand, despite positive data and new approvals.
• The company is implementing substantial R&D cuts to achieve profitability by 2028, a plan that initially underwhelmed investors.
• Recent safety concerns with Moderna's RSV vaccine in younger populations have added to the company's challenges.
• Upcoming Phase III data for Moderna's cytomegalovirus vaccine is a critical catalyst that could significantly impact the stock's trajectory.
FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions
• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity.
• Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors.
• Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors.
• Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.
PMCPA Sanctions Moderna for Code Violations in COVID-19 Vaccine Promotion and Trial Recruitment
• The UK's Prescription Medicines Code of Practice Authority (PMCPA) found Moderna in breach of industry ethics for inappropriately promoting its Spikevax COVID-19 vaccine and using unapproved clinical trial recruitment materials.
• Moderna faces financial penalties and public disclosure requirements after being found to have "brought discredit upon and reduced confidence in the pharmaceutical industry" through its actions.
• The ABPI has updated its code of practice with new mandatory disclosure requirements and procedures, set to take effect in 2025, aiming to enhance transparency in healthcare professional relationships.
EMA Approves Third Dose of Pfizer and Moderna COVID-19 Vaccines for Immunocompromised Individuals
• The European Medicines Agency (EMA) has approved a third dose of the Pfizer and Moderna vaccines for individuals with weakened immune systems, to be administered at least 28 days after the second dose.
• Studies suggest that an additional dose of these vaccines enhances the production of antibodies against COVID-19 in immunocompromised patients, potentially increasing their protection.
• For individuals with normal immune systems, booster doses may be considered at least 6 months after the second dose, particularly for those aged 18 and older, based on data showing increased antibody levels.
• The EMA will continue to monitor data on the safety and effectiveness of COVID-19 vaccines, including the risk of rare side effects following booster doses.
COVID-19 Infection During Pregnancy Does Not Impair Child's Neurodevelopment, Study Finds
• A new study indicates that children exposed to COVID-19 in utero do not show significant neurodevelopmental delays at ages 12, 18, and 24 months.
• The research examined data from over 2,000 mother-child pairs, with approximately 11% of mothers infected with COVID-19 during pregnancy.
• Follow-up analyses, considering factors like trimester of infection and fever, also found no significant differences in developmental outcomes.
• An accompanying editorial advises caution, noting potential limitations of the screening tool and conflicting findings from other studies.
Autoantibodies to Protein S Linked to Coagulopathy Following COVID-19 Vaccination
• A new study identifies autoantibodies against protein S as a potential cause of coagulation-related adverse events following COVID-19 vaccination.
• Researchers compared patients with coagulation issues post-vaccination to healthy controls and those with other adverse events.
• The study utilized bead-based assays and ELISA to detect autoantibodies, confirming protein S autoantibodies in a subset of patients.
• Functional assays suggest these autoantibodies impair protein S activity, potentially explaining the observed coagulopathy.
Moderna's mRNA Norovirus Vaccine Enters Phase 3 Trial
• Moderna's mRNA-1403 norovirus vaccine has entered a pivotal Phase 3 trial, evaluating its efficacy, safety, and immunogenicity in adults.
• The global trial, named Nova 301, aims to enroll approximately 25,000 participants, focusing on adults aged 60 years and older.
• mRNA-1403 is a trivalent vaccine designed to protect against multiple norovirus genotypes, addressing a significant public health concern.
• Interim Phase 1/2 data showed promising safety and immunogenicity, supporting the Phase 3 trial's initiation and potential for regulatory submission in 2026.
EMA Recommends Approvals for Novel Therapies Targeting Cancer, Hemophilia, and Neurological Disorders
• The EMA's CHMP recommended ten new medicines for approval, including Alhemo for hemophilia and Wainzua for hereditary transthyretin-mediated amyloidosis.
• Positive opinions were adopted for two influenza vaccines, Fluad and Flucelvax, and for Siiltibcy, a diagnostic for Mycobacterium tuberculosis infection.
• CHMP recommended extensions of indication for twelve already authorized medicines, expanding treatment options for various conditions.
• The committee elected Bruno Sepodes as its new chair and Outi Mäki-Ikola as its new vice-chair, effective September and October 2024, respectively.
Bavarian Nordic's Mpox Vaccine Shows Promise in Adolescents, Securing EMA Approval
• Bavarian Nordic's mpox vaccine, MVA-BN (Imvanex), has received EMA approval for use in adolescents aged 12-17, potentially expanding access in Africa.
• A NIH-sponsored clinical trial demonstrated that adolescents showed non-inferior immune responses and similar safety profiles to adults after two doses.
• The WHO has prequalified Imvanex for 'off-label' use, which may facilitate its use in infants, pregnant women, and immunocompromised individuals during outbreaks.
• Bavarian Nordic is planning a Phase II clinical trial to assess the immunogenicity and safety of MVA-BN in children aged 2-12 years.
Updated COVID-19 Vaccines Targeting JN.1 and KP.2 Variants Show Promise
• Updated COVID-19 vaccines targeting the JN.1 lineage have demonstrated improved immune responses against newer subvariants like KP.2 and KP.3, offering enhanced protection.
• Regulatory bodies in the US and UK have approved JN.1-specific vaccines from Moderna, Pfizer, and Novavax, with Australia currently evaluating Spikevax and Comirnaty.
• The FDA has recommended and approved vaccines targeting the KP.2 strain, with minimal difference expected between JN.1 and KP.2 boosters in providing updated protection.
• While mRNA vaccines are effective, Novavax offers an alternative protein-based option, though its updated booster is not yet under consideration in Australia.
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