Latest: Coronavirus in Spain figures (23 Dec)
The European Medicines Agency (EMA) has approved the use of the Nuvaxovid vaccine against Covid-19 for people aged 18 years, developed by the US-based Novavax, paving the way for a fifth vaccine option in Europe in addition to Pfizer-BioNTech, Moderna, AstraZeneca and Janssen.
Data from two large studies showed the vaccine has an efficacy of around 90%, the EMA said on Monday, adding that there was currently limited data on its efficacy against some variants of concern, including the fast-spreading Omicron.
The studies involved over 45,000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given a placebo (dummy) injection; in the other study, participants were equally split between Nuvaxovid and placebo. People did not know if they had been given Nuvaxovid or placebo.
The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic Covid-19 cases from seven 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). ‘This means that the vaccine had a 90.4% efficacy in this study,’ the EMA stated.
The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic Covid-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%, the EMA stated.
‘Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%,’ y the EMA concluded. ‘The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were on-going. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,’ the agency added.
‘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,’ it 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 variant, prompting renewed curbs ahead of the holidays.
The endorsement for the two-dose Nuvaxovid vaccine, 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 company said on Monday it would start shipping vaccines to the EU’s 27 member states in January.
‼️ EMA recommends Nuvaxovid, the #COVID19vaccine developed by #Novavax, for authorisation in the 🇪🇺, to prevent #COVID19 in people from 18 years of age. #HealthUnion
— EU Medicines Agency (@EMA_News) December 20, 2021
👉 https://t.co/C0CrY8Jhih pic.twitter.com/bFDwTnh4Zf
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