Novavax COVID Booster Faces Delay in EU, Receives Approval in the UK, Including Gaithersburg

19 Oct, 2023

Novavax COVID Booster Faces Delay in EU, Receives Approval in the UK, Including Gaithersburg

The United Kingdom's regulatory authorities have granted full marketing authorization for Gaithersburg-based Novavax's updated protein-based COVID-19 booster shot. However, in the European Union, the decision has been delayed.

The European Medicines Agency had been expected to approve the Novavax booster last week, but it has requested additional information. According to sources cited by the Financial Times, the agency had concerns regarding the potency of the latest version and aimed to ensure consistency in the vaccine's production across various manufacturing sites. Novavax has responded to additional queries from the European Medicines Agency's Committee for Medicinal Products for Human Use and is currently awaiting feedback.

The updated Novavax COVID vaccine had already received approval from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention the previous month. It has been distributed to pharmacies and healthcare providers in the United States. While it is too early to assess U.S. vaccination rates, Novavax remains optimistic about the ongoing rollout in the United States.

Besides the United States and the United Kingdom, the updated Novavax COVID booster has also received full authorization in Singapore.