The State Agency of Medicines (ZVA) informs that the European Medicines Agency (EMA) has started evaluating the application for conditional registration of the Covid-19 vaccine “Nuvaxovid” (also known as NVX-CoV2373) developed by the pharmaceutical company Novavax. The evaluation will be carried out under an accelerated procedure and a conclusion on the registration of the vaccine could be provided within a few weeks if the data submitted on the efficacy, safety and quality of the vaccine are of sufficient quality and completeness.
The evaluation in such a short time is possible due to the fact that the ESA has already evaluated a significant part of the data on this vaccine during the accelerated evaluation procedure, which is being carried out before the evaluation of the marketing authorization application. At this stage, the Committee for Medicinal Products for Human Use (CHMP) assessed the results of laboratory tests (non-clinical data), 19 clinical trials in adults.
At the same time, the ESA Safety Committee completed an assessment of the company’s proposed vaccine risk management plan, which sets out measures to identify, characterize and mitigate the risks of this medicine.
In addition, in accordance with the accelerated deadlines for the evaluation of Covid-19, the Committee for Medicinal Products for Pediatric Use of the ESA issued an opinion on the company’s pediatric investigation plan describing how the medicine should be developed and studied in children.
If the ESA concludes that the benefits of Nuvaxovid in protecting against Covid-19 outweigh its risks, it will recommend that the vaccine be given a conditional marketing authorization. The European Commission will then speed up its decision-making process to grant a marketing authorization for the vaccine, which will be valid in all EU and EEA Member States for a few days.
The ESA will inform the CHMP of the conclusion.
Nuvaxovid, like other Covid-19 vaccines, is expected to protect the body against infection. The vaccine contains small particles of a protein (peak or S-protein) variant of the SARS-CoV-2 virus that has been developed in a laboratory. The vaccine also contains an ‘adjuvant’, a substance that helps to strengthen the immune response to the vaccine.
After the vaccine is given, the human immune system will recognize the protein particles as out of the body and will start to make 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 will recognize the peak protein on the virus and will be ready to fight it. Together, the antibodies and immune cells can protect against Covid-19 by killing the virus, preventing it from entering the body’s cells and killing the infected cells.
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