On Monday, the EMA backed the use of Nuvaxovid, a vaccine developed by Novavax, for adults, making it the fifth Covid shot to date to be given the green light by the bloc’s drugs regulator.
“After a thorough evaluation, the EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine was robust and met the EU criteria for efficacy, safety and quality,” the agency said.
The EMA cited two large studies undertaken by the biotech firm in which the vaccine demonstrated efficacy of around 90% against strains of Covid-19 prevalent during the trials. The body admitted that there was limited data on some variants of concern, including Omicron.
The shot has been billed by some as an important development in overcoming vaccine hesitancy as Novavax’s jab is a protein vaccine which uses the same inoculation technology already used for decades against hepatitis, shingles, and other viral infections.
It requires two doses and is stable at refrigerated temperatures of between two and eight degrees Celsius. Data suggests only mild to moderate side effects are experienced by recipients.
The approval comes amid a sharp wave of new Covid-19 infections, driven by the Omicron variant. The vaccine had been undergoing a rolling review since February, and Novavax said it would start delivering to the EU in the first quarter of 2022.
It is expected that the UK will also approve the jab in the coming weeks. Novavax is yet to apply for approval in the US, where it has had to resolve manufacturing issues.
The firm’s share price jumped by more than 10% on Friday after the World Health Organization approved the shot made on license by the Serum Institute of India.
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