The European Medicines Agency (EMA) supported the use of the American vaccine on Monday Novavax for being safe and effective, so recommended authorizing your license, becoming the fifth vaccine to overcome the European scientific filter in this pandemic.
“The EMA has recommended granting a conditional marketing authorization for the COVID-19 Nuvaxovid vaccine from Novavax,” the agency explained in a press release.
First protein-based vaccine approved by the EMA
After a “comprehensive” evaluation, The EMA Committee for Human Medicines (CHMP) concludes that Novavax meets the European Union (EU) criteria for “Efficacy, safety and quality”.
This vaccine is recommended for adults over 18 years old, should be administered in two doses, with 21 days apart, and can be stored, manipulated and distributed to refrigerator temperature.
This vaccine, also known as NVX-CoV2373, is based on a stabilized form of protein S (Spike, in English) of the virus, for which a technology of nanoparticles recombinant protein.
The antigens of the purified protein in the vaccine they cannot replicate or cause COVID-19. Is the first vaccine based on proteins that the EMA recommends against COVID-19 and “will support vaccination campaigns in EU Member States during a crucial phase of the pandemic,” adds the agency.
How has it developed?
To develop the vaccine, the company studied the doses in a few 45,000 people. In the first of the studies, about two-thirds of the participants received the vaccine and the rest received a placebo injection (dummy). This first analysis found a reduction in the 90.4% in the number of symptomatic cases of COVID-19 from 7 days after the second dose.
In the second study the participants were divided equally between the Novavax vaccine and a placebo injection. In this case, the efficacy of the vaccine was 89.7%. That is, the efficacy of the vaccine in the studies was around 90%.
Efficacy against Omicron
Regarding its efficacy against variants, the EMA explains that “there are limited data on the efficacy of Nuvaxovid against other variants of interest, including omicron”. When the vaccine was in development, the most prevalent variants at the time were Alpha and Beta next to the original strain.