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The FDA on Thursday cleared Pfizer and BioNTech's updated COVID-19 vaccine for the 2026-2027 season, and shipping began the same day. The following morning BioNTech said it was ending a mid-stage cancer trial. Shares fell.
The approved vaccine, COMIRNATY XFG, targets the XFG variant of SARS-CoV-2, the strain the FDA designated as the preferred composition for vaccines entering the U.S. market this fall, according to the companies' August 27 announcement. The companies say lab data show the shot generates immune responses against multiple currently circulating variants, including XFG.1.1, NB.1.8.1 and several others.
Clearance covers adults 65 and older, and individuals aged 5 through 64 with at least one underlying condition that raises their risk of severe COVID-19 outcomes. The companies said the vaccine will be available at pharmacies, hospitals and clinics across the U.S. within days.
The COVID approval was not what moved the stock. On Friday, BioNTech separately said it was terminating a Phase 2 study of autogene cevumeran — its experimental personalised mRNA cancer vaccine — in patients with resected colorectal cancer, after an independent data safety monitoring board recommended stopping the trial for futility, according to BioSpace, which cited BioNTech's own press release. Reuters reported that BioNTech's U.S.-listed shares fell close to 9% on the news. Shares closed 8.37% lower at $102.0750, on dollar volume of about $313 million.
The colorectal cancer trial, known as BNT122-01, was testing autogene cevumeran as a standalone therapy — not in combination — to prevent disease recurrence in high-risk patients after surgery. The futility finding means the monitoring board determined the trial was unlikely to meet its goals even if it continued. No safety problems were cited as the reason for stopping, according to BioSpace.
The COVID vaccine itself carries a longer record. The companies say more than five billion doses of COMIRNATY have been distributed globally to date, and the XFG adaptation follows the same annual reformulation process as prior seasons. BioNTech holds the marketing authorisation for the vaccine in the U.S., the EU, the United Kingdom and other countries, according to the August 27 announcement.
Autogene cevumeran had been one of BioNTech's more closely watched oncology programmes. A standalone failure in colorectal cancer does not end the programme — the therapy has been studied in combination with other treatments in different tumour types — but it narrows the path for what the company had positioned as a flagship in personalised cancer immunotherapy.