March 4 COVID Quick Takes: More guidance on vaccines for variants; plus EMA begins review of Sputnik V, Novartis-CureVac, Bharat-Ocugen, Novavax and more

The ACCESS consortium, a coalition of regulatory authorities from the U.K., Australia, Canada, Singapore and Switzerland, released guidance on Thursday outlining the data needed to approve variant-specific modifications to authorized COVID-19 vaccines. According to the guidance, immunogenicity and safety data, but not clinical efficacy data, will “usually” be required for adapted vaccines. Data from the initial pivotal trials and real-world evidence may also be used to support regulatory decisions. 

EMA starts rolling review of Sputnik V 
EMA’s CHMP started a rolling review of Sputnik V, a viral vector COVID-19 vaccine from N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology. ...