Pfizer/BioNTech’s XFG-adapted COVID-19 vaccine has been approved by the US FDA, with the companies announcing the approval of the supplemental Biologics License Application (sBLA) for their 2026-2027 COVID-19 vaccine formula.

The formula targets the XFG variant and is suitable for adults aged 65 years and older, as well as in those aged from five to 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The FDA approval is based on evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY, as well as manufacturing/quality and non-clinical data showing that the XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants.

The selection of the XFG variant is based on guidance from the FDA as the preferred composition of COVID-19 vaccines for use in the US beginning in autumn 2026. The vaccine will be available in pharmacies, hospitals and clinics across the US.

To date, more than five billion doses of COMIRNATY have been distributed globally and it continues to demonstrate a favourable safety and efficacy profile.

The National Institute for Health and Care Excellence (NICE) has recommended Merck Healthcare’s Ogsiveo (nirogacestat) to treat adults with progressing desmoid tumours who require systemic treatment.

Desmoid tumours, also known as desmoid-type fibromatosis, are rare soft tissue tumours that have a reported annual incidence of approximately two to four cases per million people. In the UK, there are an estimated 340-410 new cases each year. They predominantly occur in adults aged 30-40 years and are more common in women.

Ogsiveo is the first and only systemic therapy approved in England to treat this invasive and often debilitating condition. In the phase 3 DeFi study, Ogsiveo demonstrated tumour reduction, as well as improvements in pain and quality of life.

Desmoid tumours often present as a firm or palpable lump. Symptoms vary according to the tumour location and may include pain, swelling, reduced mobility, difficulty carrying out day-to-day activities and fatigue. For some people, the pain and symptoms associated with desmoid tumours may significantly affect their mental well-being, causing anxiety, depression, fear and uncertainty about the future, as well as concerns regarding body image.