The European Union on Monday approved the use of Novavax’s Covid-19 vaccine in people 18 years and older, giving a boost to the US biotech after long delays and paving the way for a fifth shot in the EU as the Omicron variant spreads.
Data from two large studies showed the vaccine has an efficacy of around 90%, the European Medicines Agency (EMA) said.
It is not clear yet how Novavax performs against the Omicron variant, or whether a booster dose will be needed. Some early data has suggested that many two-dose vaccines do not work well against the variant while a third shot improves their efficacy.
Novavax said earlier this month it could begin manufacturing a vaccine tailored for Omicron in January.
Novavax shares closed down more than 7% on Monday.
Novavax said it would start shipping vaccines to the EU’s 27 member states in January as part of its deal to supply up to 200 million doses.
Member-states have ordered around 27 million doses for the first quarter, enough to inoculate about 13.5 million people, the Commission said.
Covid-19 infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defenses against the fast-spreading Omicron, prompting renewed curbs ahead of the Christmas holidays.
“May this authorization offer a strong encouragement to everyone who has not yet been vaccinated or boosted, that now is the time to do so,” said the head of the bloc’s executive Commission, Ursula von der Leyen, in a statement.
Vaccines from Pfizer-BioNTech, Moderna , AstraZeneca and J&J have already been approved for use in the EU.
Novavax’s protein-based vaccine uses alternative technology to the other four shots, which helps the EU diversify its portfolio of vaccines.
Still, it will be deployed into a market dominated by the Pfizer-BioNTech shot. The US-German partners have contracts for the supply of up to 2.4 billion doses through 2023 for the EU’s population of 450 million.
Almost 70% of EU citizens have received two vaccine doses and many countries are scrambling to administer third booster doses in a bid to strengthen defenses against Omicron. [Reuters]