The development and commercialization of cell and gene therapies during a pandemic, with regulators and payers demanding more data on effect duration and safety, has resulted in headwinds. Added to manufacturing and clinical trial recruitment issues, investors’ patience has been strained.

In addition to agreeing to emergency use of the Oxford University/Astra Zeneca and Sinovac vaccines, Brazil's medicines regulator has also published good manufacturing practices certificates for Pfizer and Janssen vaccine. It has questions about the Sputnik V authorization request.

A Dutch parallel registration and reimbursement pilot has brought benefits including more participation from healthcare professionals, and also forces company divisions to be less streamlined.