The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.

India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country.  Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.