The European Union’s drug regulator on Monday approved the Covid-19 vaccine from US-based Novavax in people over 18, paving the way for a fifth coronavirus shot as the Omicron variant takes hold.
Data from two large studies showed the vaccine has an efficacy of around 90%, the European Medicines Agency (EMA) said, adding 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 the fast-spreading Omicron coronavirus variant, 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 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 company said it would start shipping vaccines to the EU’s 27 member states in January.
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.
The first study, conducted in Mexico and the US, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people).
The vaccine had a 90.4% efficacy in this study.
The second study conducted in the UK also showed a similar reduction in the number of symptomatic COVID-19 cases (10 from 7,020 people) compared with people given placebo (96 from 7,019); in this study, the vaccine efficacy was 89.7%.
Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%.
There is currently limited data on the efficacy of Nuvaxovid against Omicron.
The side effects observed with Nuvaxovid were usually mild or moderate and cleared within a couple of days after vaccination.
The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headaches and nausea.