The European Medicines Agency paves the way for a fifth authorised COVID jab in the bloc, approving its use in adults.
The European Union has approved the use of Novavax’s COVID-19 vaccine in people 18 years and older, giving a boost to the US biotech after long delays and paving the way for a fifth shot in the EU as the Omicron variant spreads quickly.
Data from two large studies showed the vaccine has an efficacy of about 90 percent, the European Medicines Agency (EMA) said, adding there was currently limited data on its efficacy against some variants of concern, including Omicron.
“After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,” the regulator said on Monday.
The EU Commission followed shortly after the EMA’s decision to give the final official go ahead.
Novavax said it would start shipping vaccines to the EU’s 27 member states in January as part of its deal to supply up to 200 million doses.