EU grants full marketing authorisation for Novavax’s Covid-19 vaccine

US-based Novavax received its first full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) in the EU.

Nuvaxovid is now fully authorised as a primary series vaccine for general Covid-19 prevention for individuals aged 12 years and older and as a booster dose in adults aged 18 years and older.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2023, surrounding the vaccine’s full approval.

The full authorisation comes a few years after the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, in December 2021. At the time, Nuvaxovid was the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets worldwide.

Nuvaxovid is a novel Matrix-M adjuvant protein-based vaccine that has received a US Food and Drug Administration (FDA) emergency use authorisation but has not yet received full US approval.

In a 6 July press release, Novavax’s president and CEO John C Jacobs said: “In addition to the EU, we are preparing to file for full approval in the US as well as other markets and are committed to ensuring protein-based options are available worldwide. Vaccine choice remains an integral part of public health measures.”

The immunisation is developed by producing copies of the spike protein on the SARS-CoV-2 virus that causes the disease. As a first booster, the vaccine must be given at least six months after a patient receives their first vaccination with an approved Covid-19 vaccine.

The European Commission’s decision was based on results from the Phase III PREVENT-19 trial (NCT04611802) that investigated the safety, immunogenicity, and efficacy of Nuvaxovid. Study data demonstrated that the vaccine had an efficacy of 79.5% in preventing the disease and 82% specifically for preventing the Delta variant. According to GlobalData, the company is also studying the vaccine in nine ongoing clinical trials to evaluate its use in infants (NCT04611802), pregnant women (NCT04705116) and more patient groups.

GlobalData is the parent company of Pharmaceutical Technology.

During the pandemic, the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, making it the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets globally.