The EMA announced yesterday that it has started evaluating the application, building on data already received through a rolling review process that has been ongoing since February.
Novavax received the first authorization for its COVID-19 vaccine earlier this month in Indonesia, and has also been given the green light in The Philippines. The company expects to submit a complete package to the US Food and Drug Administration (FDA) by the end of the year.
Brand name revealed as Nuvaxovid
The vaccine, NVX-CoV2372, is set to be branded as Nuvaxovid in the EU.
If authorized, the protein-based vaccine would offer a different type of vaccine to those already authorized in the bloc (Pfizer and Moderna’s mRNA vaccines; and AstraZeneca and Johnson & Johnson’s viral vector vaccines).
A UK Phase 3 trial reported efficacy of 96.4% against the original virus strain, 86.3% against Alpha (B.1.1.7) and 89.7% efficacy overall.
A Phase 3 trial in the US & Mexico showed 100% protection against moderate/severe disease and 90.4% efficacy overall.
Phase 3 trials of Novavax' candidate have demonstrated 89.7% efficacy (96.4% efficacy against the original virus strain and 86.3% against the Alpha B.1.1.7 variant).
"Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.
The chemistry, manufacturing and controls (CMC) data package submitted to EMA (as well as other global regulatory agencies) is based on Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume.
This will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
In an update yesterday, the EMA said: “The assessment [of Novavax’s COVID-19 vaccine] will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.
“Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review. During this phase, 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.
“In parallel, 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.”
Meanwhile, the EMA’s committee for medicines for children (PDCO) has issued its opinion on Novavax’s paediatric investigation plans, which outlines how the vaccine should be developed and studied for use in children.
The Novavax/SII vaccine has recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines. The companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO).
Novavax has also made regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada and with the WHO. Earlier this week, Novavax and South Korea biotech partner SK bioscience announced a Biologics License Application (BLA) submission to the Ministry of Food and Drug Safety (MFDS) in the country.
Novavax expects to submit the complete package to the US FDA by the end of the year.
