Also known as: COVID-19 shot, COVID-19 shots, COVID vaccines
The acting director of the CDC delayed publication of a report showing the COVID-19 vaccine cut emergency department visits and hospitalizations for healthy adults last winter by about half. The Department of Health and Human Services did not immediately respond to request for comment.
Moderna shares declined nearly 6% amid extreme options market volatility and a new patent infringement lawsuit from BioNTech. The company faces significant financial challenges with negative earnings and declining revenue growth, while valuation metrics suggest potential overvaluation. Technical indicators point to bearish short-term momentum as the stock approaches key support levels.
Moderna will pay $2.25 billion to settle patent disputes with Arbutus Biopharma and Genevant Sciences over lipid nanoparticle technology used in its COVID-19 vaccine. The settlement removes uncertainty for Moderna's vaccine pipeline and sent the stock surging over 11%. The company expects to end 2026 with $4.5-$5 billion in cash and return to revenue growth by year-end.
A study of nearly 70,000 children found girls exposed to SARS-CoV-2 infection in utero had a 44% increased risk of autism spectrum disorder. The research showed 3.97% of pregnant women had COVID-19 infection, with most cases occurring in the third trimester. No increased risk was observed for boys or for speech/language and motor delays overall.
Moderna has settled with Arbutus and Genevant, facing a potential $1.3 billion liability contingent on Federal Circuit's decision. Multiple institutional investors have increased their stakes in the biotech company during recent quarters.
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06864143 |
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age |
COMPLETED | PHASE2 |
| NCT06683352 |
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People |
COMPLETED | PHASE1/PHASE2 |
| NCT06355232 |
Covid-19 and Influenza Oral Vaccine Study |
RECRUITING | PHASE1 |
| NCT06178991 |
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza. |
COMPLETED | PHASE3 |
| NCT06163677 |
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza. |
WITHDRAWN | |
| NCT06116669 |
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women |
RECRUITING | NA |
| NCT06097273 |
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age |
COMPLETED | PHASE3 |
| NCT05919472 |
Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women |
COMPLETED | NA |
| NCT05618548 |
Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium |
UNKNOWN | |
| NCT05587868 |
COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients |
UNKNOWN |
