EU authorises Novavax as bloc’s fifth vaccine against Covid-19

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The European Commission authorised on Monday the use of the US-based Novavax Covid-19 vaccine in the EU for people 18 and over, paving the way for a fifth coronavirus jab in the region as the Omicron variant spreads.

"With five approved vaccines, the EU has a varied portfolio, based both on novel technologies, such as mRNA, and classic ones, like Novavax, which is protein-based," the head of the European Commission, Ursula von der Leyen, said on Twitter.

The decision came shortly after the EU drugs regulator had recommended its approval in over-18s. The newly authorised vaccine can now be deployed in countries that have bought it, with Novavax saying Monday it would start shipping vaccines to the bloc’s 27 member states in January.

Data from two large studies showed the vaccine has an efficacy of around 90 percent, the European Medicines Agency (EMA) said, adding that 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.

Covid-19 infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defences against Omicron, prompting renewed curbs ahead of the holidays.

The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the United States, where Novavax has had to resolve manufacturing issues and expects to file for approval by the end of the year.

The regulatory process in the EU has taken longer than expected, too. The EMA started a rolling review of the data in February.

Novavax and the EU reached a preliminary deal 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 only signed in August.

The shot 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.


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