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November 17, 2021 The European Medicines Agency is evaluating the conditional marketing authorization application for Novavax's Covid vaccine, Nuvaxovid. Ema herself announced it. The evaluation will proceed quickly and an opinion "could be released within weeks if the data presented is sufficiently robust and complete to demonstrate the efficacy, safety and quality of the vaccine," reads a statement.  



"Such a short period of time - explains the Agency - is possible only because the EMA has already examined a substantial part of the data on the vaccine during a continuous review. During this phase, the Human Medicines Committee (CHMP) of the Ema evaluated data from laboratory studies (non-clinical data), some information on the quality of the vaccine and how 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 trials in adults ". 



The Nuvaxovid vaccine contains tiny particles made from a version of a protein found on the surface of Sars-Cov-2 (the Spike protein), which was made in the laboratory. It also contains an 'adjuvant', a substance that helps boost immune responses to the vaccine. When a person is given the vaccine, their immune system will identify the protein particles as foreign and produce natural defenses - antibodies and T cells - against it. they. If the vaccinated person later comes into contact with SARS-Cov-2, the immune system will recognize the Spike protein on the virus and be ready to attack it. The vaccine is produced in the United States, in August 2021 the European Union signed a contract for 200 million doses, subject to the approval of theEMA for its use against SARS-CoV-2 variants.



The EMA is also working on the request for an opinion also from Johnson & Johnson.

According to the pharmaceutical company that produces it (Janssen), it has been shown to be 100% effective against severe forms of Covid-19 after administration of two doses and 75% after a single dose.

The company therefore communicated its intention to submit to the European Medicines Agency (EMA) the authorization request for a complete package that includes the single dose plus a booster dose.

The J&J vaccine is currently licensed as a single dose.