EU Regulator Gives Novavax Green Light As Fifth COVID Vaccine Of The Block

The European Medicines Agency (EMA) said on Monday that it has authorized the vaccine from the US company Novavax against COVID-19 for use in people aged 18 and over, paving the way for a fifth coronavirus vaccine in the EU as the omicron variant of the coronavirus spreads.

Data from two large studies showed the vaccine to be around 90% effective, the EMA said, adding that there is currently limited data on its efficacy against some concerning variants, including omicron.

“After a comprehensive evaluation, the EMA Committee for Medicinal Products for Human Use (CHMP) concluded by consensus that the data on the vaccine were reliable and met EU criteria for efficacy, safety and quality,” the agency said. regulator.

COVID-19 infections have broken records in parts of Europe in recent weeks, and governments and researchers have struggled to beef up defenses against the rapidly spreading omicron variant of the coronavirus, prompting new restrictions. before the holidays.

Approval of the two-dose, brand-name Nuvaxovid vaccine comes well before possible authorization in the United States, where Novavax has faced manufacturing problems and expects to apply for approval by the end of the year.

The regulatory process in the EU has also taken longer than anticipated. The EMA began a continuous review of the data in February.

Novavax and the EU reached a preliminary agreement in December 2020 for the supply of the vaccine, but due to regulatory and production issues the final contract for up to 200 million doses was not signed until August.

The company said on Monday it would start shipping the vaccines to all 27 EU member states in January.

The vaccine received its first regulatory green light in Indonesia last month and is awaiting approval in Japan, where it would be manufactured and distributed by Takeda Pharmaceutical.