FDA Approves New COVID Vaccines, but There’s a Catch for Millions of Americans

BioNTech SE (BNTX) shares fell 10% after terminating a Phase 2 mRNA cancer vaccine trial for colorectal cancer due to futility. The setback contrasts with Moderna's recent success in melanoma, highlighting different outcomes in cancer types. BioNTech has €16.6B in cash and securities, and other trials remain ongoing. Investors await further data at ESMO Congress in October 2026.

The FDA approved COVID-19 vaccines from Pfizer, Moderna, and Sanofi targeting the XFG strain. Pfizer and Moderna's vaccines use mRNA technology, while Sanofi's does not. The approval covers individuals aged 65+ and those with underlying conditions. The CDC reports low vaccine uptake and increasing infections in 47 states.

Moderna and Merck reported success in a late-stage trial of their mRNA cancer vaccine for melanoma, marking a breakthrough after over a century of failed attempts. The vaccine, personalized for each patient, showed efficacy in preventing tumor recurrence. Wall Street estimates potential sales in the billions. Merck faces Keytruda patent expiration, while Moderna seeks new growth avenues. Both companies plan further trials and data analysis. Moderna's shares surged over 130% post-announcement.

The FDA approved updated Covid-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech on August 27, targeting the dominant XFG variant. The companies can now ship doses to pharmacies and doctors' offices, according to their statements.

Pfizer (PFE) and BioNTech (BNTX) received FDA approval for their XFG-variant COVID-19 vaccine, Comirnaty, for adults 65+ and high-risk individuals. Shipping began August 27.

The FDA approved updated Covid-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech targeting the dominant XFG variant. The vaccines are approved for individuals 65+ and younger with high-risk conditions. Manufacturers can now ship doses, but CDC recommendations and insurer coverage remain uncertain.