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EU regulators recommend approval of Novavax vaccine

December 20, 2021

The European Union’s drugs regulator has cleared the way for the protein-based vaccine, which would be the fifth shot authorized for the bloc.

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A vial of the Novavax vaccine
Indonesia was the first country to approve the Novavax vaccineImage: Tomislav Miletic/PIXSELL/picture alliance

The European Medicines Agency (EMA) said Monday its experts recommend the conditional approval of the the Novavax vaccine.

The EU has already signed a deal to buy up to 200 million doses of vaccine, pending authorization for its use by the Amsterdam-based EMA.

The shot uses a more conventional technology than other vaccines — and is expected to be of particular use in the developing world. It's also thought that, because the vaccine uses a more conventional method to deliver immunity than alternatives, it could help address vaccine uncertainty.

Once the European Commission approves, Novavax will be the fifth vaccine approved for use in the bloc.

Novavax said its vaccine showed 90.4% efficacy against COVID-19 in a trial in North America. The company says it will start delivering vaccines to the EU in January.

Ahead of the expected announcement, Novavax Chief Executive Stanley Erck said the firm "looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform."

The vaccine "may help address major obstacles to global vaccination, including global distribution challenges and vaccine hesitancy," he added.

Why is Novavax different?

Novavax uses a similar technology as vaccines for hepatitis B and whooping cough, which do not have to be kept in ultra-low temperatures. This could give it a competitive edge logistically, particularly in regions with less-developed infrastructure.

It employs genetic engineering to grow harmless copies of the protein spike on the virus' coat. The spike is then purified and mixed with a chemical that boosts the immune system.

Newer technologies are used in the EU's existing vaccines. AstraZeneca and Johnson & Johnson use a common cold virus to deliver the genetic message that can provide immunity. BioNTech-Pfizer and Moderna use a hitherto largely untested Messenger RNA technology.

The World Health Organization last week gave emergency approval to the vaccine, which is produced by the US-based firm Novavax and the Serum Institute of India.

The vaccine — CovavaxTM — was the ninth vaccine to be granted approval by the body.

Novavax is currently is testing how the shots perform against the omicron variant. Like other manufacturers, it has started to formulate an updated jab geared to combat omicron specifically.

Ask Derrick: Novavax Rollout

rc/rt (AFP, dpa, Reuters, AP)