EU drug regulator gives green light to US Novavax Covid vaccine

Europe's medicines watchdog has approved a Covid jab by US-based Novavax, which uses a more conventional technology that the biotech firm hopes will reduce vaccine hesitancy. 

Novavax said in January 2021 that its Covid-19 vaccine showed 89.3% efficacy in a phase 3 clinical trial. JUSTIN TALLIS AFP/Archivos

In a statement released this Monday, the European Medicines Agency said: "EMA has recommended granting a conditional marketing authorisation for Novavax's Covid-19 vaccine Nuvaxovid to prevent Covid-19 in people from 18 years of age."

Novavax is the fifth vaccine to be recommended for authorisation in the European Union, as the Omicron variant spreads across the bloc.

The US-developed vaccine is expected to start rolling out its deliveries to the European Union in the first quarter of 2022.

‼️ EMA recommends Nuvaxovid, the #COVID19vaccine developed by #Novavax, for authorisation in the 🇪🇺, to prevent #COVID19 in people from 18 years of age. #HealthUnion

👉 https://t.co/C0CrY8Jhih pic.twitter.com/bFDwTnh4Zf

— EU Medicines Agency (@EMA_News) December 20, 2021

Data shows upto 90% efficacy against Covid

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

The regulator added: "After a thorough evaluation, EMA's human medicines committee concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality."

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 holidays.

• Europe steps up vaccination of young kids as Omicron gains ground
• Moderna boss warns vaccines will struggle against Omicron variant

Red tape and regulation led to delays

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 European Medicines Agency 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 company said on Monday it would start shipping vaccines to the EU's 27 member states in January.

The shot received its first regulatory greenlight in Indonesia last month and is currently awaiting approval in Japan.