EU regulator approves Novavax as region's fifth Covid-19 vaccine

Novavax said it would start shipping vaccines to 27 EU member states in January

Europe's medicines watchdog has approved the Covid shot from US-based Novavax. AFP

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The EU's drug regulator on Monday approved the use of the Covid-19 vaccine from US-based company Novavax for people 18 years and older, paving the way for a fifth coronavirus shot in the region as the Omicron variant spreads.

Data from two large studies showed the vaccine has an efficacy of about 90 per cent, the European Medicines Agency (EMA) said, though it added there was 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.

Novavax said it would start shipping vaccines to the EU's 27 member states in January. Its Nasdaq-listed shares were up about 10 per cent in US premarket trading following the EU approval.

Coronavirus infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defences against the fast-spreading Omicron variant, prompting renewed curbs before the Christmas holidays.

The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well before possible authorisation in the US, where Novavax has had to resolve manufacturing issues before it files for approval by the end of the year.

The regulatory process in the EU has taken longer than expected, too. Novavax and the EU reached a preliminary deal in December 2020 to supply 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.

Once EMA has endorsed or refused a product, the executive body of the EU, the European Commission, makes the final decision, which typically matches what EMA has said.

Separately, Novavax said the commission's decision was expected “imminently".

Novavax's protein-based vaccine uses different technology from the other four shots, which makes it a more intriguing option as the EU seeks to diversify its portfolio of vaccines.

The company has about eight manufacturing locations, including those at the Serum Institute of India (SII), the world's biggest vaccine maker.

Production of the shot in India at the SII has also been approved by EMA, an EU official said.

Antigens for the vaccine, the inactivated organisms that trigger an immune response, are made at Novavax's factory in the Czech Republic.

This month, Novavax said it could begin manufacturing a vaccine tailored to Omicron in January while it continues to test whether its current vaccine works against the variant.

On Friday, the World Health Organisation issued an emergency use listing for SII's version of the Novavax vaccine.