EMA Expects Data on Omicron-Specific Vaccine as Early as April

By Reuters Staff

March 18, 2022

(Reuters) - The European Medicines Agency's (EMA) leading vaccine expert on Thursday said that data on COVID-19 vaccines tailored for the Omicron variant should be available between April and the start of July, potentially paving the way for approval this summer.

Vaccine makers such as Moderna and Pfizer have begun testing COVID-19 vaccines designed to target Omicron after data showing that two initial COVID-19 vaccine doses provide only partial protection against the variant.

Based on data for Omicron-specific vaccines, the agency will decide on a timeline for the potential granting of approval.

The agency hopes to have the data this summer, thereby increasing the chances of a vaccine being available for use in the autumn, said Marco Cavaleri, the EMA's head of vaccines strategy.

The EMA added that its review of Russia's Sputnik V coronavirus vaccine has been halted.

"There is no activity in the review ... and I don't anticipate any in the immediate future," Fergus Sweeney, head of the Clinical Studies and Manufacturing Taskforce, said without elaborating.

The World Health Organization (WHO) on Wednesday delayed its assessment of Sputnik V for emergency use because of Russia's invasion of Ukraine.

A WHO official said the agency was facing other operational issues, including difficulties in booking flights and using credit cards.