Filenews 17 November 2021
The European Medicines Agency (EMA) has begun evaluating the application for a conditional marketing authorisation for Novavax's COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The evaluation will evolve with an accelerated timetable and a relevant opinion on the marketing authorisation may be issued within weeks, provided that the data submitted are sufficiently robust and complete to substantiate the efficacy, safety and quality of the vaccine.
The shortened timeline is possible as the EMA has already evaluated a significant portion of the data on the vaccine during a rolling review. During this phase, the EMA's Committee for Medicinal Products for Human Use (CHMP) evaluated data from laboratory studies (non-clinical data), some information on the quality and production of the vaccine as well as data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against COVID-19 from clinical studies in adults.
At the same time, the EMA's Safety Committee (PRAC) has completed its preliminary assessment of the company's proposed Risk Management Plan (RMP), which outlines measures to identify, characterize and minimise the risks of the drug.
In addition, the EMA Committee on Medicines for Children (PDCO) has issued its recommendation for the company's paediatric investigation plan (PIP), which describes how the drug is developed and studied for use in children, in line with accelerated timelines for drugs against COVID-19.
If the EMA concludes that Nuvaxovid's benefits outweigh its risks in terms of protection against COVID-19, it will recommend that a conditional marketing authorisation be issued. The European Commission will then speed up the decision-making process with a view to issuing a conditional marketing authorisation within days, which will be valid in all EU and EEA Member States.
The EMA will contact further in the opinion of the CHMP.
How the vaccine is expected to work
Like other vaccines, Nuvaxovid is expected to prepare the body to defend itself against infection. The vaccine contains tiny particles of a laboratory version of the protein found on the surface of SARS-CoV-2 (spike protein (S)),. It also contains an "adjuvant", a substance that helps boost immune responses to the vaccine.
When a person is given the vaccine, his immune system will recognize the protein particles as foreign and produce natural defences - antibodies and T cells - against them. If, later, the vaccinated person comes into contact with the SARS-CoV-2 virus, the immune system will recognize the spike protein in the virus and be ready for attack. Antibodies and cells of the immune system can protect against COVID-19 by killing the virus through synergy, preventing it from entering the body's cells and destroying infected cells.
