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Coronavirus pandemic
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Coronavirus: EU backs US’ Novavax as bloc’s 5th vaccine amid Omicron spread

  • Endorsement for two-dose jab comes ahead of possible authorisation in US, where firm has had to resolve manufacturing issues
  • Firm to start shipping vaccines to EU’s 27 member states in January; first regulatory ‘green light’ in Indonesia last month, awaiting approval in Japan

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Europe’s medicines watchdog has approved a Covid-19 vaccine by US-based Novavax. Photo: AFP
Reuters
The European Union’s drug regulator on Monday approved use of the Covid-19 vaccine from US-based Novavax in people aged 18 years and older, paving the way for a fifth coronavirus shot in the region as the Omicron coronavirus variant spreads.

Data from two large studies showed the vaccine has an efficacy of around 90 per cent, the European Medicines Agency (EMA) said, adding that there was currently limited data on its efficacy against some variants of concern, including Omicron.

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“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.

A health worker administers a Covid-19 vaccine to a child in Lisbon, Portugal, on December 19. Photo: Bloomberg
A health worker administers a Covid-19 vaccine to a child in Lisbon, Portugal, on December 19. Photo: Bloomberg

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

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The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the US, 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 European Medicines Agency started a rolling review of the data in February.

Demonstrators carry a placard depicting a child wearing a mask during a protest against Covid-19 restrictions in Belgium on December 19. The omicron mutation has added an extra layer of uncertainty, but Europe’s immediate problem is grappling with the wave of infections that has already put countries back into lockdown. Photo: Bloomberg
Demonstrators carry a placard depicting a child wearing a mask during a protest against Covid-19 restrictions in Belgium on December 19. The omicron mutation has added an extra layer of uncertainty, but Europe’s immediate problem is grappling with the wave of infections that has already put countries back into lockdown. Photo: Bloomberg

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.

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