The European Medicines Agency is evaluating the conditional marketing authorization application for Novavax’s Covid vaccine, Nuvaxovid. Ema herself made it known. 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.
Covid, Novavax asks WHO for emergency authorization for the vaccine
Covid vaccines for teens, how they work and which ones could be approved
by Valeria Pini
“In parallel – continues the note – the safety committee of Ema (Prac) has completed the preliminary assessment of the risk management plan proposed by the company, which outlines the measures to identify, characterize and minimize the risks of the drug .
Second dose vaccine, that’s why switching is not a good idea
by Elvira Naselli
In addition, EMA’s Committee for Medicinal Products for Children has issued its opinion on the company’s pediatric investigation plan, which describes how the medicine should be developed and designed for use in children, in accordance with the accelerated timeframe for Covid-19 medicines.
Covid, the Novavax vaccine authorized for the first time in Indonesia
by Fiammetta Cupellaro
“Novavax vaccine 90.4% effective”
by Valeria Pini
If the EMA concludes that Nuvaxovid’s benefits outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorization. The European Commission will therefore speed up the decision-making process in order to grant a conditional marketing authorization valid in all EU and SEA member states within a few days “.
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 will produce natural defenses – antibodies and T cells – against them. If, later, the vaccinated person comes into contact with SARS-Cov-2, the immune system will recognize the spike protein on the virus and be ready to attack it.
Novavax, a Covid vaccine different from all the ones we have
by Daniele Banfi
.