ESA has received an application for conditional registration of Novavax Covid-19 – archyde

The State Medicines Agency (ZVA) has announced that the European Medicines Agency (EMA) has started examining the application for the conditional registration of the Covid-19 vaccine “Nuvaxovid” (also known as NVX-CoV2373) developed by the pharmaceutical company Novavax. The assessment will be carried out in an accelerated process and a conclusion on the registration of the vaccine could be made within a few weeks if the data provided on the efficacy, safety and quality of the vaccine are of sufficient quality and completeness.

The evaluation in such a short time is possible because the ESA has already evaluated a substantial part of the data on this vaccine as part of the accelerated evaluation process, which is carried out before the evaluation of the approval application. During this phase, the Committee for Medicinal Products for Human Use (CHMP) evaluated the results of laboratory tests (non-clinical data) from 19 clinical studies in adults.

At the same time, ESA’s Safety Committee completed an assessment of the company’s proposed vaccine risk management plan, which includes measures to identify, characterize and mitigate the risks of this medicine.

In addition, in line with the expedited deadlines for the assessment of Covid-19, ESA’s Pediatric Medicines Committee has issued an opinion on the company’s pediatric investigation plan, which outlines how the medicine should be developed and tested in children.

If the ESA concludes that Nuvaxovid’s benefits outweigh its risks in protecting against Covid-19, it will recommend that the vaccine be given conditional marketing authorization. The European Commission will then accelerate its decision-making process for granting a marketing authorization for the vaccine, which is valid for a few days in all EU and EEA member states.

ESA will inform the CHMP of the conclusion.

Nuvaxovid, like other Covid-19 vaccines, is designed to protect the body from infection. The vaccine contains small particles of a protein variant (peak or S-protein) of the SARS-CoV-2 virus developed in the laboratory. The vaccine also contains an ‘adjuvant’, a substance that helps increase the immune response to the vaccine.

After the vaccination, the human immune system recognizes the protein particles as foreign and begins a natural defense against them (antibodies and T cells). If a vaccinated person is later exposed to the SARS-CoV-2 virus, the immune system recognizes the peak protein of the virus and is ready to fight it. Together, the antibodies and immune cells can protect against Covid-19 by killing the virus, preventing it from entering the cells of the body and killing the infected cells.

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