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 U.S. biotech after long delays and paving the way for a fifth shot in the EU as the Omicron variant spreads quickly.
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.
The EU Commission followed shortly after the EMA’s decision to give the final official go ahead.
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 defences 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.
The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorization in the United States, where Novavax has had to resolve manufacturing issues and expects to file for approval of its first ever vaccine by the end of the year.
The regulatory process in the EU has taken longer than expected too. The EMA started a real-time 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 was only signed in August.
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.
On Friday, the World Health Organization (WHO) issued an emergency use listing to Novavax‘s vaccine made by the Serum Institute of India (SII), the world’s biggest vaccine maker, paving the way for its use in low- and middle-income countries where rollout has been much slower than in Europe.
Novavax said on Monday it had received the WHO’s emergency use listing for the company’s own version of the vaccine, which it will distribute in Europe and other markets.
Vaccines from Pfizer-BioNTech,, Moderna , AstraZeneca and J&J have already been approved for use in the EU. But faced with surging infections, the EMA has been speeding up reviews of other shots and treatments.
Novavax‘s protein-based vaccine uses alternative technology to the other four shots, which makes it more interesting to the EU as it has sought to diversify its portfolio of vaccines.
Still, it will be deployed into a market dominated by the Pfizer-BioNTech shot. The U.S.-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 vaccines and many countries are scrambling to administer third booster doses of the shot in a bid to strengthen defenses against Omicron.
With concerns about rare blood clotting, many EU countries have reduced their use of the AstraZeneca and J&J shots and many have donated them to low-income countries directly or through the COVAX program run by the WHO.
Novavax has about eight manufacturing locations, including those of the SII. Production of the shot in India at SII has also been approved by the EMA, an EU official told Reuters.
Antigens for the vaccine, the inactivated organisms that trigger an immune response, are made at Novavax‘s factory in the Czech Republic.
Novavax said earlier this month it could begin manufacturing a vaccine tailored for Omicron in January, while it tests its current vaccine against the variant.