Pfizer and BioNTech have stopped recruiting for a large U.S. trial of their updated COVID‑19 vaccine, citing insufficient enrollment to generate the required data.
The trial, which targeted adults aged 50‑64, was designed to meet the FDA’s new requirement for large, placebo‑controlled studies in that age group. Enrollment stalled because more than 80 % of interested participants failed pre‑screening due to health criteria, and vaccine fatigue and a perceived lower risk of severe COVID‑19 have reduced willingness to enroll. Competition from other vaccines and the overall contraction of the COVID‑19 vaccine market have also contributed to the shortfall.
The pause delays the collection of efficacy and safety data for the updated formulation, potentially postponing regulatory submissions and the launch of a product that could have generated additional revenue. The broader market is expected to shrink from $13.71 billion in 2025 to $8.28 billion by 2030, underscoring the strategic shift away from COVID‑19 vaccines toward other therapeutic areas.
Pfizer’s fourth‑quarter 2025 revenue fell 1 % YoY, largely due to a decline in COVID‑19 product revenue, while excluding those products the company grew 9 % operationally. BioNTech’s full‑year 2025 revenue is projected at €2‑2.3 billion, with lower COVID‑19 vaccine sales in both Europe and the United States. Both companies are increasingly focusing on oncology and other high‑growth segments.
On the day of the announcement, Pfizer and U.S.‑listed BioNTech shares rose about half a percent, while Moderna’s shares climbed 2 %. The muted market reaction reflects the broader context of a contracting vaccine market and the companies’ strategic pivot to non‑COVID‑19 products.
Management commentary from BioNTech’s CFO Jens Holstein in November 2024 highlighted low demand and pricing pressures in low‑ and middle‑income countries, which has guided the company toward the lower end of its annual revenue expectations for COVID‑19 vaccines. The halt in recruitment aligns with that outlook and signals a continued shift away from the pandemic‑era product line.
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