The World Health Organization (WHO) and Chubb Ltd. signed an agreement creating a no-fault vaccine injury compensation program on behalf of the COVAX Facility, which is making COVID-19 vaccines available to 92 low- and middle-income countries. The program will provide compensation for rare but serious adverse events associated with the COVAX-distributed vaccines until June 30, 2022. Initially, the compensation program will be financed through donor funding, calculated as a levy charged on all doses of the vaccines distributed through COVAX, according to the WHO.
The U.K.’s Medicines and Healthcare Products Regulatory Agency updated three more guidances Feb. 23 to help drug companies navigate new Brexit procedures. The latest updates are related to applying for the unfettered access procedure for marketing authorizations approved in Northern Ireland, the European Commission reliance procedure, and the decentralized and mutual recognition procedure for marketing authorizations. All three guidances were first published Jan. 4.
The FDA is seeking public comment on topics that should be discussed at a workshop to be held later this year on best practices for developing and applying disease-progression models to support drug development, according to a notice to be published in the Feb. 24 Federal Register. Comments should be submitted to Docket No. FDA-2021-N-0031 by March 26.