The European Medicines Agency (EMA) has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid, the agency announced.
The EU assessment will proceed under an accelerated timeline.
An opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the vaccine’s efficacy, safety, and quality.
The regulator said it could come to a swift decision because it had already started a rolling review of the clinical data backing the vaccine in February.
During the rolling review, EMA’s human medicines committee (CHMP) assessed data from laboratory studies (non-clinical data), some information on the quality of the vaccine and the way it will be produced, and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against COVID-19 from clinical studies in adults.
EMA’s safety committee (PRAC) completed the preliminary assessment of the risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine’s risks.
Furthermore, EMA’s committee for medicines for children (PDCO) has issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children under the accelerated timelines for COVID-19 medicines.
If EMA concludes the benefits of Nuvaxovid outweigh its risks in protecting against COVID-19, it will recommend granting a conditional marketing authorisation.
The shot is the first protein-based vaccine to be assessed by the EMA.
Novavax submitted its authorisation request in October to the UK’s regulator, and, earlier this month, Indonesia became the first country to approve the vaccine.
Protein-based vaccines can be stored in a normal fridge, making them an alternative to more expensive shots that require ultra-cold chain storage and distribution.