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Inactivated vaccine: Novavax applied for EU approval

Inactivated vaccine: Novavax applied for EU approval

Status: 11/17/2021 6:15 PM

The American pharmaceutical company Novavax has applied for a marketing authorization in the European Union for the vaccine. The European Union Medicines Agency wants to announce a decision on the first protein-based vaccine against Covid-19 in a few weeks.

A fifth vaccine against Covid-19 could soon be approved in the European Union. The European Medicines Agency (EMA) has announced that it intends to accelerate the examination of the application for approval of the vaccine from the American biotechnology company Novavax.

A decision can be made within a few weeks “if the data provided are sufficiently reliable and complete to demonstrate the efficacy, safety and quality of the vaccine.” It will be the first protein vaccine against Covid-19 to be approved.

If the EMA recommends a conditional marketing authorization, the EU Commission must still give its final approval. But this is a matter of form.

Unlike pre-approved vaccines, a Novavax product called Nuvaxovid (NVX-CoV2373) is neither an mRNA vaccine — like preparations from BioNTech and Moderna — nor a vector vaccine like those from AstraZeneca and Johnson & Johnson.

It is called a dead vaccine. The vaccine contains small particles made from a laboratory copy of the spike protein Sars-CoV-2. The body’s defense system interacts with protein “extracts”, thus building up immune protection against COVID-19 diseases. Many influenza vaccines also work according to this principle – with the difference that protein “clumps” of influenza viruses stimulate an immune reaction to them. Like all vaccines, Nuvaxovid is designed to prepare the immune system for potential infections.

In the crucial Phase 3 study of 30,000 patients, the vaccine showed an overall efficacy of about 90 percent. However, the intended approval was delayed because Novavax had to deal with production problems.

The European Union secures 200 million cans

The vaccine won emergency approval this month in the Philippines and Indonesia. The application for US approval is due to be submitted at the end of the year. The European Union has secured up to 200 million cans from the company.